Medicine Archives - Page 2 of 4

Women in Science – Ann Graham from fighting cancer to helping kids

Finding herself on a pediatric ward something inside her changed and she became determined to do something to help the youngsters who were being robbed of so much. Read her truly inspiring story in our most recent Women in Science feature, we were truly humbled after speaking with her. Could you give us an overview…

Skye and Beacon collaborate on sleep pnea in obesity trial

As Skye embarks on their CBeyond phase 2 clinical trial, we explore the motivation, methodology, and expected outcomes of incorporating Beacon’s advanced sleep monitoring technology into their research. We also discuss the broader implications of this partnership and the potential for nimacimab to transform the treatment landscape for obesity and OSA. Can you provide more…

pharmacovigilance with AI and innovation

James, who joined Qinecsa three years ago after stints at Genpact and Accenture, discussed the company’s mission, products, and the critical role of AI and machine learning (ML) in shaping the future of PV. Qinecsa’s mission and offerings Qinecsa is a PV technology and services company dedicated to enhancing patient safety. “We have a suite…

Strategies for CDMOs to prepare for the 2032 BioSecure Act

This article features insights from leading experts at CAI, including Alice Redmond, Harry Benson, Jonathan Thompson, and David Shenberger. They discuss strategies for optimizing facilities, balancing costs, and leveraging advanced technologies to navigate the upcoming regulatory landscape. With the BioSecure Act set to take full effect by January 2032, what immediate steps should domestic CDMOs…

AI tool enhances drug discovery for age-related diseases

The organizations say this collaboration uses the strengths of both to create a cutting-edge platform designed to uncover new insights into drugs, diseases, and biological networks by systematically exploring hidden biological patterns. The new discovery tool, to be developed on SAS Viya, a robust cloud-native AI and data platform, will, they say, combine Rejuvenate Biomed’s…

Bateman Horne Center advances ME/CFS and long COVID care

As a 501(c)(3) nonprofit organization, BHC has made significant strides in addressing chronic health challenges that affect millions of people globally. In recognition of the critical role of medical education in improving patient care, the Open Medicine Foundation (OMF) partnered with BHC in 2022 to create the OMF-supported Medical Education Resource Center (MERC). Now celebrating…

Oxford experts unveil breakthrough online therapies for anxiety and PTSD

These internet-based solutions are designed to support patients with social anxiety disorder, post-traumatic stress disorder (PTSD), and anxiety disorders in children, and they have been recommended by the National Institute for Health and Care Excellence (NICE) for their efficacy and accessibility. Despite the UK government’s commitment to allocate 8.9% of NHS funding to mental health…

Women in Science – Ann Graham from fighting cancer to helping kids

Piramal Pharma Solutions surpasses revenue milestone in innovation

For the first time, revenue earned from innovation programs has surpassed that from generic projects. Over the past five years, Piramal has seen its innovation revenue rise from 35% of total revenue in FY19 to more than 50% in FY24, representing a Compound Annual Growth Rate (CAGR) of 20%. Commercial manufacturing This significant growth includes…

Shaping the future of clinical trials through data and AI

Clark highlights several key trends and advancements shaping the industry today. The explosion of data and complexity Clark opens the discussion by pointing out the unprecedented growth in data volume and complexity in clinical trials. “There’s a significant explosion in the amount of data coming out,” he notes, emphasizing that this data influx comes from…

Understanding the impact of ICH E6(R3) on clinical research

The E6(R3) Guideline for Good Clinical Practice revises ICH E6(R2) and is expected to go live in 2025. To understand the potential impacts of this guideline on clinical research, Outsourcing-Pharma spoke with TransCelerate BioPharma Inc. member Madeleine Whitehead, RBQM Product and People Lead at Roche, and ACRO Forum member Nicole Stansbury, senior vice president of…

Challenges and strategies in parenteral drug development at Lonza

To gain insight into this complex landscape, we spoke with Abbas Razvi, head of pharmaceutical development, and Sandro Holzer, head of process development bioconjugates at Lonza. In this Q&A, they share their expertise on accelerating development timelines, integrating new technologies, navigating regulatory hurdles, and ensuring high-quality standards. Discover how Lonza uses creative strategies and interdepartmental…

Women in Science: Deep Genomics’ Tehmina Masud

With an inquisitive mind and by asking endless questions, she soon found herself studying medicine and fully understanding what her dad meant when he said the future of medicine lay within genetics, mathematics and computer science. Read our interview to find out how Tehmina ended up as vice president and head of target identification at…

$2 Million in grants awarded to tackle neurodegenerative diseases

This funding will be distributed over two years to four pioneering research projects that emerged from the Tauopathy Challenge Workshop. The Tauopathy Challenge Workshop, initiated to bridge gaps in the understanding of primary tauopathies such as Frontotemporal Dementias (FTDs) and Progressive Supranuclear Palsy (PSP), brought together neuroscience experts from around the globe. The workshop focused…

EU rejects lecanemab for Alzheimer’s treatment

On Friday (July 26), the European Union’s drugs regulator, the Committee for Medicinal Products for Human Use (CHMP), advised that the drug lecanemab, a treatment for Alzheimer’s disease, should not be approved for use in the EU. The decision comes as a disappointment to many in the medical community, especially given the promising research behind…

Next-gen mobile technologies transform clinical research

By creating a future of cheaper and faster studies, these innovations are paving the way for more targeted treatments and therapy advancements. In this article, we explore recent advancements in clinical trials, the role of patient engagement, and the impact of AI and data analytics on research efficiency and accuracy. Advancements in clinical trials: Embracing…

More power to the pharmacists or is the extra work too much?

The move was made to help free up access to care for patients across pharmacies and dental practices and to give patients faster, simpler and fairer access to primary care. This article follows on from a story published in OSP about how pharmacists will be able to intervene to help identify people at risk of…

IQVIA’s One Home – streamlining clinical research tech

This SaaS-based solution simplifies the workflow for clinical trial site staff, enabling them to focus more on patient care and advancing trials, thereby reducing delays and increasing the number of trials that can be managed simultaneously. OSP spoke to Liss Easy, VP and GM clinical technologies at IQVIA to find out how. Can you explain what…

Donanemab approval – a new era for Alzheimer’s treatment

At the Alzheimer’s Association International Conference, experts from the Emmes Group discussed the impact of this new therapy on the future of Alzheimer’s drug development, the importance of early detection, and innovative strategies for clinical trials. So, what donanemab’s approval means for the Alzheimer’s treatment landscape? The approval of donanemab is a game-changer in the…

Cure51 co-founders on changing cancer treatment

In this exclusive interview, they share insights into their mission to decode exceptional cancer survival cases, their innovative methodologies, and future plans to transform oncology. Can you tell us more about the founding story of Cure51 and what inspired you to start this venture? Cure51 was founded on the principle that the answers to some…

pharmacovigilance with AI and innovation

Bellamy, who joined Qinecsa three years ago after stints at Jam Packs and Accenture, discussed the company’s mission, products, and the critical role of AI and machine learning (ML) in shaping the future of PV. Qinecsa’s mission and offerings Qinecsa is a PV technology and services company dedicated to enhancing patient safety. “We have a…

Agilent snaps up biologics CDMO BIOVECTRA

The deal, which was financed by cash and debt financing, is due to close before 2025 and will see BIOVECTRA shuffled into Agilent’s Diagnostics and Genomics Group. Agilent will blend BIOVECTRA’s expertise in biologics and active pharmaceutical ingredients with its own CDMO services, which specialize in oligonucleotides and therapeutics based on the gene editing tool…

Third Arc Bio to run multiple programs in 2025 thanks to funding

Third Arc Bio has announced the closing of a $165 million series A round led by Vida Ventures and co-led by Cormorant Asset Management and Hillhouse Investment. Multiple other investors participated, including Omega Funds, Goldman Sachs Alternatives, and AbbVie Ventures among others. The Boston-based company develops multifunctional antibodies that can precisely activate or inhibit T…

Rusan Pharma’s Ankleshwar facility gains US FDA GMP approval

This significant milestone, achieved following a comprehensive five-day on-site inspection from April 29 to May 3, 2024, marks a critical step in Rusan Pharma’s expansion into the US API market. Dr Kunal Saxena, managing director of Rusan Pharma, said: “This GMP approval by the US Food and Drug Administration underscores our unwavering commitment to maintaining…

Inspiring women in science: Laura Child’s journey

Her journey in life sciences began with a deep childhood curiosity about the natural world, leading to a career in drug development and clinical trials. Laura’s experience spans from working as a clinical research associate to becoming a program director, and eventually transitioning into the marketing side of life sciences. Along the way, she has…

Women in Science: Neurologist Antonella Favit-VanPelt

From asking endless questions about the causes of illness as a young girl to pioneering therapeutic innovations as an adult, Dr Favit-VanPelt’s journey is marked by relentless curiosity and a drive to find new ways to help patients. Her advice to young women entering science is simple yet profound: be curious, challenge the status quo,…

ViiV Healthcare reports positive data on Apretude use during pregnancy

The findings come from the HIV Prevention Trials Network (HPTN) 084 open label extension (OLE) study, which evaluated cis-gender women in sub-Saharan Africa who became pregnant while using Apretude for HIV pre-exposure prophylaxis (PrEP). According to ViiV Healthcare, the data showed that Apretude was generally well tolerated among pregnant women and maintained cabotegravir levels above…

Pharmacists’ key role in liver health and disease prevention

Her leadership encompasses visionary support, development, and advocacy for FIP’s 144 member organizations, representing four million members globally. Dr. Duggan’s responsibilities include strategic planning and collaboration with international entities like WHO and the UN. Additionally, she chairs the World Professions Health Alliance, which advocates for 31 million health professionals across various disciplines, including medicine, nursing,…

JOGO Health collaborates with Mayo Clinic to study tremors

This partnership aims to revolutionize the understanding and treatment of various tremor conditions, using the combined expertise of both organizations in medical analysis and device development. The collaboration is framed as a ‘know-how’ agreement, wherein the two entities will pool their respective strengths to delve into Parkinson’s tremors, functional tremors (FT), and essential tremors (ET).…

Caroline Shleifer: Leading AI-driven regulatory intelligence

She has a PharmD-PhD in Medical Physics and is a seasoned professional with a deep understanding of healthcare, law, and regulatory affairs. We were delighted to speak to her as one of our Women in Science to find more about her journey to get where she is now and what she learnt along the way. …

GLP-1 drug demand sees €900M investment from CordenPharma

The expansion will cover existing facilities as well as brand new constructions. CordenPharma aims for all its facilities to meet the most stringent quality and technical standards for the manufacturing of peptides with pharmaceutical purposes, including biological license application (BLA) requirements to facilitate the approval of biological products. CordenPharma’s facilities in the Colorado, US site…

Roche announces good early results for oral GLP-1 receptor agonist

Genentech, a Roche Group member, announced this week that its investigational oral, glucagon-like peptide-1 (GLP-1) receptor agonist CT-996 showed good results at phase 1, with a 6% reduction in weight at 4 weeks compared with placebo. Roche acquired CT-996 as part of its $2.7 billion acquisition of Carmot Therapeutics, a biotech based in Berkeley, California,…

The top 5 CDMOs developing advanced therapies

The manufacturing and regulatory process of biopharmaceuticals is highly complex and costly to implement, which can be challenging for big pharma companies and startups to take on themselves. Outsourcing the task to CDMOs allows these companies to spend less of their own time and resources at the cost of surrendering full control of the process.…

Avista and Hamilton Lane partner to grow Cosette Pharmaceuticals

The companies will jointly control Cosette, with a focus on accelerating innovation and growth. Since Avista’s initial investment in Cosette in December 2018, Cosette has launched new products through research and development efforts, acquisitions, and licensing deals. This includes the acquisition of Ambien and Ambien CR in the United States from Sanofi US. The company…

FDA approves Voquenza for non-erosive GERD treatment

This marks the third FDA approval for Voquenza, which is also approved for treating all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and in combination with antibiotics for eradicating Helicobacter pylori (H. pylori) infection. A significant milestone for GERD patients Terrie Curran, president and CEO of Phathom Pharmaceuticals, a biopharmaceutical company, highlighted…

Marwan Fathallah’s vision for DIA, the future of healthcare innovation

With an impressive career spanning 35 years in the healthcare industry, Fathallah shares his vision for the future of DIA and the evolving landscape of healthcare and diagnostics. Liza Laws (LL): What motivated you to join DIA in 2023, and what are your primary goals as President and CEO? Marwan Fathallah (MF): I’ve been in…

Nipro Invests $397.8M in NC, creating 232 jobs in Pitt County

This significant project is set to create 232 jobs in Pitt County and marks a milestone in Nipro’s expansion into the U.S. market. “North Carolina’s highly skilled workforce, top-notch education system, and leadership in the life sciences industry continue to attract projects that make a difference in the lives of everyday North Carolinians,” said Christopher…

IDT expands synthetic biology facility to boost capacity

This state-of-the-art facility not only doubles IDT’s production capacity but also introduces cutting-edge technologies and energy-efficient measures to enhance gene synthesis capabilities. With rapid gene synthesis offerings on the horizon and a strategic vision for growth, IDT is poised to meet the burgeoning demand in the synthetic biology market and drive the next wave of…

Transforming healthcare with a data-driven focus

By leveraging diverse data sources and advanced analytics, the company says it empowers the healthcare continuum to make informed clinical decisions, streamline processes, and improve patient outcomes. Its mission is to transform healthcare delivery by addressing gaps in care and supporting the development of personalized interventions, ultimately driving patient-centered innovation and enhancing overall healthcare quality.…

Celadon completes eighth harvest, on track for 15 in 2024

This accomplishment highlights the company’s creative approach and steady march towards completing 15 harvests within the calendar year. With its eighth harvest now successfully completed, Celadon Pharmaceuticals is not just meeting expectations but setting new standards in the cultivation and production of cannabis-based medicines. This achievement marks a pivotal step forward in the company’s mission…

The top 5 startups developing psychedelic drugs

Investment in psychedelic drugs started booming in 2020. The lockdowns brought by the Covid-19 pandemic highlighted the importance of mental health, and the legalization of psychoactive compounds is progressively spreading worldwide. A key milestone was the FDA decision in 2020 to fast-track and award breakthrough designation to a depression treatment based on psilocybin from Compass…

An Interview with Tim Martin of Yseop

In an insightful interview, Tim Martin, vice president, product, at Yseop, discusses the company’s recent advancements, notable collaborations, and the significant impact their AI-driven solutions are having on big pharma. He was speaking to senior editor, Liza Laws, during DIA Global in San Diego. From enhancing the efficiency of medical writers to ensuring data privacy…

How does Leal Health’s GenAI transform cancer patient care?

This innovation is poised to transform patient access to cancer care by leveraging advanced AI capabilities to provide personalized treatment options, streamline patient journeys, and enhance overall care. LL: Can you provide an overview of Leal Health’s new GenAI single point of access technology and how it revolutionizes patient access to cancer care? The addition…

How is wearable tech enhancing sleep tracking in clinical trials?

Her insights, captured in the white paper “Closing the Gap in Our Understanding of Sleep Health with Fit-for-Purpose Wearable Digital Health Technologies,” underscore the transformative potential of wearables in providing accurate, real-world sleep data. This comprehensive understanding is essential for improving patient outcomes and supporting regulatory approvals. The white paper is available for download here.…

Tyra Biosciences announces proof of concept data in hypochondroplasia

Tyra Biosciences has released positive results from a preclinical proof of concept study testing its lead drug candidate, TYRA-300, in animal models of hypochondroplasia (HCH). HCH is a type of skeletal dysplasia, a genetic condition that causes the underdevelopment of limbs and other body parts. There are currently no approved treatments for people living with…

Vox Pop Pharma – where will AI be in five years?

Industry leaders give their takes on what else is in store for AI-based tools in the pharma space. AI-powered algorithms have taken many industries by storm and pharma is no exception. For example, many companies are using AI to empower drug discovery and the search for disease targets by crunching reams of literature, helping human…

CEO discusses hormone-free male birth control development

Bakshi shares the innovative approach of YCT-529, the results of their Phase 1a study, and the anticipated impact on reducing unintended pregnancies. This conversation highlights the significance of male contraception in the broader landscape of reproductive health and the challenges faced in pioneering such a transformative solution. What inspired you to develop a hormone-free birth…

Unlocking innovation: Women in Science

In this interview, she shares insights into her role, personal journey, challenges faced, and advice for aspiring women in science. Could you give us an overview of your work?  My role as a global technical developer at Roquette revolves around uncovering new ways to unlock business opportunities through high-quality pharmaceutical excipients. This can look like…

Barriers to opioid treatment access in the US

This Q&A with Sheeba Ibidunni, public health expert and the VP of operations at Sonara Health explores the socio-economic factors fuelling the epidemic, the barriers to accessing life-saving medications, promising government interventions, the impact of state laws, and innovative solutions like telehealth platforms. Can you elaborate on the specific socio-economic factors that you believe are fueling…

Unveiling a key player in ovarian cancer survival

The initiative seeks to understand the crucial role of the omentum, a lesser-known yet vital organ in cancer treatment and overall health. From diagnosis to determination Meg’s journey with ovarian cancer began in 2014, marked by vague symptoms like nausea and abdominal distension. “I looked like I was four months pregnant by night,” she recalls.…

dsm-firmenich unveils advanced CBD drug product intermediate

The IP-protected CBD intermediate brings superior functionality allowing for a higher drug loading compared to currently commercially available products, paving the way for oral dosage forms with enhanced bioavailability. This will enable the development of more convenient and patient-friendly dosage forms – like tablets, including orally disintegrating tablets (ODTs) or chewables – making CBtru a…

Women in Science – Vector Labs’ Pam James

With a lot of familial inspiration, an early love of science developed for Pam James, here we find out how she got to reach her position of vice president. Could you give us an overview of your work? I serve as the VP, Product at Vector Laboratories. I oversee R&D, product management, product marketing,…

How does the FDA’s Accelerated Approval Program impact patients?

Ginny brings a wealth of knowledge and experience to the table from her diverse background in nursing, law, and regulatory policy. The conversation delved into the intricacies of global regulatory practices and the importance of collaboration in the industry. Liza Laws (LL): Thanks for joining me, Ginny. Could you start by introducing yourself and explaining your…

Eli Lilly enters $140M partnership with Radionetics Oncology

Eli Lilly has entered a strategic partnership with Radionetics Oncology, a biotechnology company focusing on the discovery and development of targeted radiopharmaceuticals to treat a broad range of solid tumors. As part of the agreement, Eli Lilly will pay $140 million upfront to Radionetics Oncology with the goal of advancing the company’s pipeline of drug…

CatSci acquires Reach Separations to offer chromatography services

The deal was supported by Keensight Capital, a private equity manager focusing on pan-European investments in the technology and healthcare sectors. Headquartered in the UK, and with facilities in the UK and France, Reach Separations provides state-of-the-art chromatography services for the analysis and purification of therapeutics. The company makes use of supercritical fluid chromatography (SLC)…

Tyra Biosciences announces proof of concept data in hypochondroplasia

How is wearable tech enhancing sleep tracking in clinical trials?

Esteve invests €100 million in Spanish API manufacturing muscle

The construction project will be financed until 2026 by a €100 million ($108 million) investment by the company. The facilities, slated to begin operations in early 2026, will involve production and service buildings in addition to up to 150 cubic meters of reaction volume. With the new manufacturing facility, Esteve expects its production capacity in…

ALS treatment slows down disease progression by 36%

Results from the PARADIGM clinical trial have revealed that PrimeC, a treatment being developed by NeuroSense Therapeutics, was able to significantly slow down disease progression in ALS patients. The phase 2b clinical trial recruited 68 people living with ALS across Canada, Italy and Israel, who were followed for up to 18 months. ALS patients treated…

ELRIG UK & The Protein Society host drug discovery conference

This collaboration aims to unite experts from various fields to explore how emerging protein science can address the challenges in drug discovery. ELRIG UK, known for its commitment to delivering high-quality scientific conferences and networking events, focuses on innovative research that can transform drug discovery. TPS, an international scholarly society dedicated to advancing protein research,…

Revolutionizing clinical trials: Yonalink’s game-changing tech

YonaLink, a pioneering company in digital healthcare, is set to change that. In an in-depth interview with senior editor, Liza Laws, Gav Martell, co-founder of Yonalink, shared insights into his journey, the company’s groundbreaking technology, and the promising future of clinical trials. The genesis of Yonalink Gav Martell’s path to Yonalink is a testament to…

The evolution of personalized medicine for reproductive health

Also known as precision medicine, this kind of individualized treatment is designed specifically for the patient and has revolutionized cancer therapies in recent years. These treatments also have massive potential for reproductive health and, by extension, the developmental and reproductive toxicology (DART) field, which studies the toxicological effects on reproductive health and development. The most…

The pharma industry’s commitment to sustainability

These efforts are driven by the need for transparency, compliance, and sustainability in response to pressures from stakeholders, including investors, regulators, and consumers. In this piece, industry experts share their insights on the actions being taken and the challenges faced in this important area. Insights from industry leaders: Nic Nunn-Faron, nonprofit & local government advisory…

FDA greenlights Verona’s game-changing COPD drug Ohtuvayre

This groundbreaking approval is expected to transform the market for patients suffering from moderate to severe exacerbations, particularly those with limited treatment options. Asiyah Nawab, a Pharma Analyst at GlobalData, provides her expert insights on the approval and its implications. “Ohtuvayre, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, has great potential to dominate the market…

The top 5 emerging startups fuelling drug discovery with AI

Check out five upcoming AI players attracting investor attention for their potential to speed up drug discovery. Drug discovery is a laborious undertaking that traditionally involves lots of trial-and-error drug screening to arrive at a potential candidate for further development. For this reason, the process can take several years and many millions of dollars to…

Revolutionizing clinical trials: Yonalink’s game-changing tech

Mainz Biomed’s cancer stool test takes on liquid biopsies

In an interview with Biopharma Reporter, Mainz Biomed CEO Guido Baechler explains how his company’s stool test for colorectal cancer compares with well known, multicancer blood tests like Galleri. Early detection blood tests such as Grail’s Galleri typically involve isolating DNA from the blood and deploying machine-learning algorithms to scan the DNA for early signs…

Will Novo Nordisk’s $4.1BN US investment transform drug manufacturing?

This expansion, one of the largest in the company’s history, aims to enhance the production of injectable treatments for obesity and chronic diseases. This investment will create 1.4 million square feet of production space, doubling the footprint of Novo Nordisk’s existing facilities in North Carolina. The new facility will generate 1,000 jobs, in addition to…

How does the FDA’s Accelerated Approval Program impact patients?

Sonara Health’s innovative app enhancing access to methadone treatment

With his background in psychiatry, Michael observed the daily struggles of patients in Opioid Treatment Programs and developed Sonara to offer a more flexible and supportive approach. This groundbreaking solution allows patients to demonstrate responsible methadone use, earn take-home doses faster, and achieve their recovery goals with greater ease. Liza Laws (LL): If you could…

CluePoints’ growth investment from EQT: What’s next?

CluePoints is a cloud-based software platform specializing in Risk-Based Quality Management (RBQM) and data quality oversight in clinical trials. The platform is designed to streamline processes, improve data integrity, and ensure risk compliance, making clinical trials safer and more efficient. The investment by EQT, a firm with a strong track record in healthcare and technology,…

EMA’s new clinical trials guideline

This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP had a conversation with Vesta…

Deep dive – why did IQVIA launch a participant payments service?

IQVIA recognized the intricate challenges associated with participant payments in clinical trials, which often involve cumbersome processes and multiple vendors, leading to delays and dissatisfaction among participants. Jim provides insights into the motivations and objectives behind launching this comprehensive solution. Can you explain the core motivations behind launching IQVIA’s participant payments service? IQVIA recognized the…

Mainz Biomed’s cancer stool test takes on liquid biopsies

How are AI and real-world data speeding up drug development?

The panel featured Ariel Berger, executive director of integrated solutions and real-world evidence at Aventura; John Van Hoy, executive director of AI and advanced analytics at PPD; and Gino Pirro, vice president of product and technology at PPD. The conversation highlighted how AI and real-world data are transforming the landscape of clinical trials. Disease models…

Is behavioral science key to patient-focused drug development?

Last year, Astellas Pharma established a behavioral science consortium to perform research aimed at better understanding what matters to patients and their carers, findings that will be channeled into drug development. Health organizations are developing a keen interest in behavioral science too. The World Health Organization (WHO) recently appealed for experts to join its global…

How will Cellibre’s $2M NIH grant revolutionize pharma production?

This first-of-its-kind phase 2 grant will expedite the commercialization of cannabinoid ingredient production via precision fermentation. The funding aims to develop cost-effective active pharmaceutical ingredients for treating conditions such as appetite suppression, obesity, inflammation, and diabetes. Cellibre, established in 2019 by a team of biomanufacturing innovators, is dedicated to creating a sustainable manufacturing company that…

DSP Expansion Adds 200,000 sq.ft. to Boost R&D Capacity

The expansion will introduce 200,000 sq. ft. of additional space, addressing the growing demand for Grade-A facilities amid a rising global appetite for research and development (R&D). The new storage and logistics areas will support over 500 customers, including industry giants such as AstraZeneca, Pfizer, BeiGene, and GE Healthcare. This expansion aligns with Dubai’s strategic…

uMotif revolutionizing clinical trials with innovative eCOA solutions

However, the eCOA/ePRO market has seen minimal innovation since the transition from paper-based forms to digital formats two decades ago, leaving a gap in meeting the escalating demand for improved patient reported outcomes driven by heightened regulatory requirements. Speaking on the pressing need for industry-wide transformation, Steve Rosenberg, CEO of eCOA/ePRO provider uMotif, he said:…

Combogesic IV – a new era of opioid-free pain relief medication?

This new medication, approved by the US FDA in October 2023, combines 1,000 mg of acetaminophen and 300 mg of ibuprofen to address mild to severe pain in adults. The introduction of Combogesic IV offers healthcare providers in the US an innovative and non-opioid option for pain management. The American Society of Anesthesiology (ASA) emphasizes…

How does genetic polymorphism affect Alzheimer’s treatments?

This key study explores the influence of CYP2C9 genetic polymorphisms on the pharmacokinetics (PK) of delta-9-tetrahydrocannabinol (THC) and its active metabolites in Alzheimer’s disease (AD) patients. Titled ‘A study on CYP2C9 polymorphism, in Puerto Rican Alzheimer’s patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol,’ it is accessible at the European Society of Medicine website.…

CluePoints’ growth investment from EQT: What’s next?

EMA’s new clinical trials guideline

How will Thermo Fisher’s new EU Facility impact trials?

This expansion of Thermo Fisher’s clinical trial network in Europe will help foster global clinical trial innovation and provide biorepository storage solutions. Thermo Fisher Scientific Inc., a global leader in serving science, has launched this cutting-edge facility to support pharma and biopharma customers with tailored, end-to-end solutions throughout the clinical supply chain. This includes services…

What are the challenges in signal management in pharmacovigilance?

The conversation delves into the complexities of signal management in the PV landscape, highlighting recent advancements and the challenges faced under stringent regulatory requirements. Dr Buddha shares his expertise on how evolving technologies and methodologies are enhancing the detection, evaluation, and management of drug safety signals, ensuring patient safety and regulatory compliance. LL: The life sciences…

Lokavant unveils AI solution for clinical trial optimization at DIA

Spectrum supports study teams by providing real-time predictions and control over trial timelines and costs, ensuring successful trials in today’s complex landscape. Clinical trials today are more intricate than ever. Late-phase studies now collect over 3.5 million data points, triple the amount from a decade ago, and must juggle an average of 26 endpoints, including…

How does genetic polymorphism affect Alzheimer’s treatments?

Lokavant unveils AI solution for clinical trial optimization at DIA

How does genetic polymorphism affect Alzheimer’s treatments?

Systech unveils game-changing turnkey solution for pharma rework and aggregation

In a groundbreaking development, Systech, a subsidiary of Markem-Imaje and Dover, has introduced a turnkey manual aggregation and rework solution tailored for pharmaceutical manufacturers, CMOs, CDMOs, re-packagers, and wholesalers.

uMotif revolutionizing clinical trials with innovative eCOA solutions

GiftHealth’s vow to enhance patient outcomes

John Romano, president, and co-founder, shares exclusive insights into how these innovations are set to tackle industry challenges and enhance patient outcomes. Can you share any new products or services your company is unveiling at this year’s DIA? The Gifthealth team continues to innovate and develop tools to improve the medication access journey for patients.…

how CluePoints is transforming research

This was to discuss what they describe as the groundbreaking impact of their Sub-population Optimization & Modeling Solution (SOMS). This cutting-edge technology, he says, integrated with advanced artificial intelligence, is poised to transform the landscape of clinical trials. Here’s what you need to know about how SOMS is setting new standards in trial precision, rescue…

path forward is giving sites their own log-in credentials

Advarra is set to reveal solutions tailored to address current challenges in the pharmaceutical and healthcare industries. With the results from the 2023 Advarra Site Survey highlighting the burden of training and use of sponsor technology on sites, it is putting forward solutions such as single sign-on and integrated technology ecosystems to streamline study start-up…

Lokavant unveils AI feasibility solution at DIA 2024

This innovative technology allows study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction. By automatically incorporating ongoing financial forecasting, Spectrum dynamically adjusts budgets based on real data, ensuring accurate modeling and efficient trial management. Product and Service Innovations: Can you share any new…

A year of innovation: Roquette’s US center milestone

The center, envisioned as a hub for groundbreaking research and development in pharmaceutical sciences, has thus far successfully lived up to its promise of fostering innovation and accelerating drug development. To gain deeper insights into the successes and future directions of the US Innovation Center, Outsourcing Pharma had the privilege of speaking with Vinod Tuliani,…

Is Stardog AI the cure for pharma batch delays?

Enter Stardog, an AI and data startup at the forefront of revolutionizing how drugs are brought to market. As pharmaceutical companies navigate the complexities of manufacturing, one major bottleneck emerges: the quarantine process. Batches placed in quarantine can lead to significant delays as plant operators struggle to pinpoint the root cause of issues that prevent…

FDA and CluePoints agreement boosting clinical data quality

FDA and its stakeholders have a vested interest in ensuring the integrity of clinical trial data and the safety of participants while clinical research is being conducted. People taking part in clinical trials can be put at significant risk of harm if clinical research misconduct such as fabrication or omission of data in reporting study…

Is Stardog AI the cure for pharma batch delays?

Enzene Bioscience’s creative approach to biosimilars

He says the strategic expansion into continuous manufacturing facilities aims to revolutionize the accessibility and affordability of life-saving medicines. LL: Could you introduce yourself and share a bit about your background leading up to your role at Enzene? HG: My journey in bioprocessing started with a PhD in biochemistry from the University of Tennessee. I…

Positive CHMP opinion for Mirum’s Livmarli in PFIC

This endorsement comes from the phase 3 March study showing a highly significant reduction in pruritus severity compared to placebo across all PFIC types. The CHMP’s assessment highlights that Livmarli offers significant clinical benefits over existing therapies. Additionally, the Committee for Orphan Medicinal Products (COMP) recommended maintaining the Orphan Drug Designation for Livmarli in PFIC.…

Shionogi expands infectious disease R&D to the US

The big announcement was made at the BIO International Convention, where top policy and health leaders gathered to discuss the future of pandemic preparedness and antimicrobial resistance. The new lab, established through Shionogi’s group company Qpex Biopharma, is set to boost their capabilities in infectious disease and pandemic preparedness. The new Shionogi Qpex Lab will…

Diane Lacroix on Clinical Trials Day

Diane shares her expert insights on how creative data solutions are transforming the landscape of clinical research, enhancing efficiency, and improving patient outcomes. What significance did Clinical Trials Day hold for your company? Each year, Clinical Trials Day is an opportunity for eClinical Solutions to celebrate the people involved in clinical trials and the advancements…

Revolutionizing drug development: AI’s game-changing potential

Christine Allen, a veteran with 25 years in drug formulation, is at the forefront of this breakthrough. She says Intrepid Lab’s innovative AI-driven platform is poised to transform drug development, drastically reducing costs, and improving success rates. From rapidly optimizing formulations to extending the life of off-patent drugs, this technology, she tells OSP, promises a…

Greenphire wins big at the 2024 MedTech Breakthrough Award

The company says its mission is geared towards enhancing clinical research site performance and participant satisfaction. This prestigious accolade recognizes Greenphire’s outstanding achievements in improving the participant experience through advanced patient-facing solutions. This marks the company’s fifth consecutive win, highlighting its sustained excellence in innovative solutions, client support, and ongoing advancements. The MedTech Breakthrough Awards…

UK’s Celadon shipping cannabis-based medicine to the US

Following the signing of an introductory sales contract with a long-established American business, Celadon has successfully shipped two different medical cannabis products across the pond. This shipment represents the company’s first international commercial supply. The American business is a supplier to various US government departments, and this initial sale has the potential to grow into…

Women in Science – this week Orla Cussen

Coming from Donegal in the northwest of Ireland, where there isn’t much industry to a more than 20 years supporting engineers, she explains how she got from A to B and the challenges and triumphs she encountered along the way. Could you give us an overview of your work? I am the engagement delivery lead…

biggest psychiatric breakthrough in 40 years

Cybin is driven by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches – developing differentiated next-generation psychedelic therapeutics – and treatment regimens to address the unmet needs of patients across a multitude of mental health issues. After receiving just two doses of one of Cybin’s developing drugs – three weeks apart – a…

Asahi Kasei’s $1.1 billion power move

This strategic acquisition, valued at approximately SEK 11.8 billion (around $1.1 billion), aims to make Calliditas a wholly owned subsidiary, significantly boosting Asahi Kasei’s international footprint. With shareholders offered SEK 208 ($20) per share and SEK 416 ($39) per ADS, and major stakeholders already on board, this deal is poised to revolutionize Asahi Kasei’s presence…

how can pharma companies fight antimicrobial resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As…

Bicycle Therapeutics balance sheet boosted by $555M

The recent financing boosts Bicycle Therapeutics’ balance sheet, bringing the pro forma cash position to approximately $1 billion. This financial runway is expected to extend into the second half of 2027, providing robust support for the ongoing advancement of their clinical-stage pipeline. Kevin Lee, CEO of Bicycle Therapeutics, said: “We are excited to announce today’s…

Atropos funding surge enhancing AI in healthcare

This funding surge comes as the company continues to advance the application of generative AI through its platform, Geneva OS. The investment round was spearheaded by Valtruis, with substantial contributions from Cencora Ventures, McKesson Ventures, and Merck Global Health Innovation Fund, in addition to the continued support of existing backers like Breyer Capital, Emerson Collective,…

Swixx Biopharma creating new breed of global pharma partners

It has achieved this with the acquisition of Pharma Consulting Group S.A., the holding company of Laboratorios Biopas SA. This move significantly extends and transforms Swixx BioPharma’s footprint, adding $220 million in sales, over 300 employees, and therapeutic coverage in neurology, oncology, immunology, gastroenterology, rare diseases, and specialty. The acquisition of Biopas is immediately accretive,…

Elinzanetant shows significant reduction in menopausal hot flashes

Detailed results from studies Oasis 1 and 2 will be showcased at the 2024 ACOG Annual Clinical & Scientific Meeting in San Francisco. The studies demonstrate that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, associated with menopause in women. This…

How has geopolitical tension created problems for life sciences?

She has a PharmD-PhD in Medical Physics and is a seasoned professional with a deep understanding of healthcare, law, and regulatory affairs. OSP was extremely keen to speak to Caroline and dig deep into a major talking point in the industry – the geopolitical tensions between the US and China and to find out everything…

Study digs deep on clinical trials to find out what sponsors want

The survey included 127 pharmaceutical sponsor respondents and 79 research site respondents, analyzing their perspectives working together on site feasibility questionnaires. OSP wanted to dig a little deeper into the findings so arranged to speak to Marcy Kravet, head of oncology strategy at Inato. What were the key motivations behind conducting this survey on site feasibility…

Clinical Trials Day – Praxis on putting people first

The association says the day (May 20) is a ‘joyful opportunity to pause in reflection, recognition, and admiration of all that has been accomplished thanks to clinical trials and the people behind them’. OSP had plenty of questions to put to Karen Grobe, senior vice president, managing director and Karen Renzi, vice president, strategy both at…

How can One2Treat revolutionize clinical trial designs?

One2Treat aims to make the clinical trial process as seamless as possible and answered a number of the questions we put to Samuel Salvaggio who bridges clinical insights with biostatistics. Patient Engagement: How do you involve patients in the design and execution of your clinical trials? We place a strong emphasis on incorporating patient…

Startup facilitating catheter insertion by improving probe usability

Samuel Poulin, presented Install-VASc and shared his insights into another innovative project aimed at transforming ultrasound-guided catheter insertion, highlighting the potential for improved patient outcomes and reduced healthcare costs. He explained that in the evolving world of medical technology, the accurate insertion of catheters remains a significant challenge. “Currently, caregivers insert catheters by hand, which…

how can pharma companies fight antimicrobial resistance?

How is SamaCare reducing financial and patient burdens?

This round was led by new investor Questa Capital, with participation from existing investors Vive Collective and South Park Commons. With this new investment, SamaCare aims to accelerate the development of its one-stop patient access platform, designed to save healthcare organizations time and resources while ensuring that patients receive therapy sooner. The company says it…

How can One2Treat revolutionize clinical trial designs?

Pam Diamond – The Sound of Medicine

Here she explains all about the challenges and triumphs that saw her reach her position of chief medical officer at Curavit including her links to the Sound of Music’s von Trapp family. Could you give us an overview of your work? I received my medical degree from the University of Rochester School of Medicine in…

Durect’s hope for people with alcohol-related hepatitis

Durect Corporation is a late-stage biopharma company championing the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury and cancer through the use of larsucosterol. James E. Brown, president and CEO of Durect, said: “We’re pleased with the FDA’s decision to grant Breakthrough Therapy designation to…

PrecisionLife and Metrodora Institute join forces

The goal is to propel clinical trials aimed at speeding-up the diagnosis and treatment of ME/CFS and long COVID patients. The trials, slated to enroll up to 1,000 participants, are set to unveil outcomes as early as this year, marking a significant stride in the quest for enhanced medical solutions for these debilitating conditions. Myalgic encephalomyelitis,…

How has geopolitical tension created problems for life sciences?

Indica Labs gets FDA clearance for platform giving pathologists the best tools

This significant 510(k) clearance permits the use of HALO AP Dx in conjunction with the Hamamatsu NanoZoomerS360MD Slide scanner for in-vitro diagnostic use and paves the way for its future compatibility with additional FDA-cleared slide scanners. HALO AP is a globally deployed enterprise digital pathology platform that Indica Labs says has revolutionized the analysis, management,…

Novartis to showcase next-gen manufacturing solutions at BIO 2024

BPR: What new products or innovations is Novartis showcasing at BIO 2024 this year? At BIO 2024, Novartis Contract Manufacturing will actively demonstrate its commitment to supporting both existing and potential manufacturing partners around the globe, by showcasing its cutting-edge technologies. These capacities include mammalian drug substance manufacturing, microbial drug substance manufacturing, cell therapy, gene…

ReciBioPharm seizes viral and nucleic acid therapeutics opportunity at BIO 2024

BPR: What new products or innovations is your company showcasing at BIO 24? This year, we’re showcasing our fully integrated, digitally controlled, nested RNA manufacturing platform. BPR: What are you hoping to achieve from the event? We aim to share our innovations with mRNA developers and look forward to connecting with new friends and family…

‘BIO is a very important convention for us’

BPR: What new products or innovations is Cytiva showcasing at BIO 2024 this year? BIO is a very important convention for Cytiva. We are really looking forward to speaking with our customers and potential customers about how we can better collaborate and work together to accelerate the development of advanced therapeutics. Just ahead of BIO,…

Ecolab Life Sciences to showcase bioquell qube and more at BIO 2024

BPR: What new products or innovations is your company showcasing at BIO 2024 this year? This year we are delighted to share our innovative modular rapid bio-decontamination isolator – the bioquell qube. Providing all the essentials in isolation technology to protect critical bio-processing aseptic steps in a plug and play modular isolator which can be scaled up…

Inceptua expands early access program for cefiderocol in Latin America

While antimicrobial resistance is on the rise, a greater number of people still succumb to infections caused by drug-sensitive bacteria. The study reveals that ongoing development of drug resistance is unavoidable, driven by the large populations of pathogens and their exposure to antibiotics. Furthermore, the researchers say, opportunistic pathogens will continue to endanger patients with…

Elinzanetant shows significant reduction in menopausal hot flushes

New drug offers safer, non-toxic alternative for pain relief

The drug, SRP-001’s promising results from its phase 1 trial were also published. The announcement was made by South Rampart Pharma Inc. and the study was led by Hernan Bazan, co-founder and CEO of South Rampart. It was titled “Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region,”…

Showcasing innovation in cell line development technology

BPR: What new products or innovations is Abzena showcasing at BIO 2024 this year? Abzena has recently launched our AbZelect and AbZelectPRO cell line development (CLD) platforms, to enable the rapid generation and selection of high-yielding mammalian cell lines for therapeutic protein and recombinant vaccine production. Thiobridge is Abzena’s conjugation technology that makes use of the…

Study highlights lack of awareness of cholesterol-related cardiac risks

Presented at ISPOR 2024, the findings emphasize the need for integrating patient needs and preferences into strategies for managing unhealthy cholesterol (low-density lipoprotein cholesterol or LDL-C). The community-led research, a first of its kind by Global Heart Hub, aims to drive action towards changing the course of atherosclerotic cardiovascular disease (ASCVD), the leading cause of…

Roquette’s new capsules – solving drug delivery issues

The company says its new product, built on its advanced Lycagel pea starch technology, offers manufacturers the freedom to select the optimal plasticizer combination, customizing formulations to meet diverse production and end-user needs. It also sets new standards in quality, stability, and performance for plant-based softgels. Gelatin-based softgel capsules are widely used in the nutraceutical…

Oral drug for kidney disease launched in China by Everest Medicine

This official launch marks a significant advancement in patient care in mainland China, introducing a new era in the treatment of IgA nephropathy (IgAN). IgA nephropathy (IgAN) is a common chronic kidney disease which mainly affects young adults. In IgAN a protein called immunoglobulin A (IgA) becomes trapped in the very fine filters of the kidney (glomeruli), causing…

Sanofi’s billion euro investment in France

This move is part of a larger €3.5 billion program within the country. The investment will be allocated to facilities in Vitry-sur-Seine in Val de Marne, Le Trait in Seine-Maritime, and Lyon Gerland in the Rhône region. Its primary objective is to reduce France and the wider EU’s dependence on manufacturing capacity outside the region,…

AI platform to be used in fight against cancer

Brian Hashemi, executive chairman and CEO of Novigenix, and Sabine Tejpar, founder of the IMMUcan Consortium, are leading this collaborative effort aimed at driving groundbreaking advancements in immuno-oncology through the amalgamation of cutting-edge technologies and collaborative expertise. The IMMUcan Consortium, under the guidance of Merck and the European Organisation for Research and Treatment of Cancer…

Has the battle against antipsychotic weight gain been won?

The Virginia-based company has revealed promising results from its phase 1b clinical trial assessing RDX-002, a novel small molecule therapy designed to address this pressing medical concern. The trial, conducted over two weeks, has yielded findings that emphasize the potential of RDX-002 in mitigating the adverse metabolic effects associated with antipsychotic medications, the company says.…

Owlstone Medical secures $6.5M for breath-based diagnostics

The money is to support the development of breath-based diagnostics for infectious diseases. The funding comprises a $5 million equity investment and an initial $1.5 million grant from the Bill & Melinda Gates Foundation, marking the foundation’s first equity position in a breath diagnostics company. The Bill & Melinda Gates Foundation (BMGF), formed from the…

Montreal miniseries – startup AFX Medical’s brainchild

Yesterday, (April 29), during a packed program of events, OSP was invited to watch presentations from four startups nurtured by Centech, that are reaching a critical stage in their projects. In a series of articles, these will be covered as part of several interviews, presentations, and visits, OSP was lucky enough to attend and cover.…

Lonza unveils AI-powered route scouting service for small molecule development

This offering aims to streamline the identification of synthetic routes for novel active pharmaceutical ingredients (APIs) by using Lonza’s extensive chemical supply chain intelligence and in-house expertise, combined with AI technology from Elsevier (Reaxys). The development pipeline for small molecule APIs is becoming increasingly complex, driven by the intricate structures of modern drug candidates. As…

Life sciences sector deserves a purposeful fit-to-fund programme

Titled ‘State of the Discovery Nation (SODN) 2024: Fostering a Dynamic, Sustainable Medicines Discovery Sector,’ the report published in conjunction with the UK BioIndustry Association and the Association of the British Pharmaceutical Industry highlights the critical need for concerted efforts to mitigate funding risks in medicines discovery and attract more investors. The report emphasizes the…

Shionogi pays Maze $150M to advance Pompe disease compound to trial

The agreement, announced today, underscores Shionogi’s dedication to expanding its pipeline in the rare disease domain. According to the National Organization for Rare Disorders (NORD) Pompe disease is a rare disease continuum with variable rates of disease progression and different ages of onset. First symptoms can occur at any age from birth to late adulthood.…

Development leap in addressing neurological conditions

This first-in-human study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117567 in healthy adult participants. The compound, a muscarinic M1 preferring (M1/M4) selective agonist, holds promise for addressing cognitive symptoms in patients with neurological and neuropsychiatric conditions. Muscarinic receptors, pivotal in various bodily functions including brain activity, have long been targeted for…

Is investing in mental health a smart business decision?

As Mental Health Awareness Week 2024 approaches, employers must recognize the power of data in improving staff wellbeing. Peter Taylor, senior director, and global head of human resources at Phastar, sheds light on this critical issue, emphasizing the need for proactive measures to support employees’ mental health. “The costs of low mental health, both personal…

Montreal’s Displaid – disrupting the cardiac landscape

This week the second in the series comes from Jonathan Boudreau, a co-founder of Displaid and a finalist in the Effervescence conference startup competition. He spoke out on Displaid’s mission: to disrupt the landscape of cardiac care without resorting to invasive procedures. His presentation was a call to address the looming global crisis of heart…

Boehringer’s global health mission: Fighting C-R-M diseases

This initiative will integrate select Walgreens community pharmacies as clinical trial sites, focusing on phase 3 trials for individuals grappling with obesity or being overweight, and type 2 diabetes. The collaboration seeks to break down barriers and foster representation, particularly among underrepresented communities among black and Hispanic adults in the US. Ramita Tandon, chief clinical…

From ninth grade biology to the STEM industry

Having been originally interested in engineering, she soon realized that path was not the best for the set of skills she had before beginning her journey into life sciences. OSP: Could you give us an overview of your work? My current role is Vice President of Scientific Affairs at BioIVT. I lead an amazing team…

PCI Pharma Services $100M capital investment fill finish project

The ongoing construction and validation activities mark a significant step in the company’s ambitious $100 million capital investment project, tipped for completion later this year, with full-scale production set to commence in early 2025. The new 50,000-square-foot facility will feature twin lyophilizers and a state-of-the-art large-scale isolator filling line, forming the backbone of PCI’s commitment…

Elevating healthcare product launches through smart data

Inizio Engage, a life science consulting firm, is aiming to address this challenge through its data-driven and evidence-based methodology. During a presentation at Reuters Pharma USA, Mike Stout, president, US commercial, and Sese Abhulimen, president, global decision optimization, outlined how the company is focused on optimizing brands and accelerating impact using data. “We want to…

An interview with LGM Pharma

LGM Pharma, under Raje’s visionary stewardship, has undergone a remarkable journey of expansion and transformation since its acquisition by New Harbour Capital Private Equity in 2018. Initially focusing on supply chain logistics, the company has since diversified its offerings to encompass manufacturing, formulation development, and analytical services, solidifying its position as a holistic solution provider…

An improvement for lab rat welfare as Olden Labs says AI can help

Using artificial intelligence (AI), genetic engineering, and robotics, the company said it proudly introduces the world’s first automated animal research lab. Founded by a team of experts spanning diverse disciplines, including a Harvard PhD biologist, a Forbes 30 Under 30 AI developer, and engineers from 10X Genomics and Apple, Olden Labs stands backed by supporters…

Psychedelic hub offers course for professionals to develop in the field

Starting on May 27 in London, this practitioner program is designed for healthcare professionals and students in professional training who are interested in delving into the psychedelic-assisted therapy area. The course aims to equip participants with the necessary knowledge to safely, ethically, and effectively administer psychedelic treatments within a regulated healthcare environment. Upon completion of…

A look into Organon’s mission and vision

However, Canadian company Organon wants to change this, a spin off from Merck & Co., Inc., it has a mission to focus solely on women’s health globally. The company is led by by CEO Michael Casia and he says: “Our mission is deeply rooted in the belief that women’s health deserves dedicated attention and resources. “We aim to…

Owlstone Medical secures $6.5M for breath-based diagnostics

From banking to biotech – Renée Aguiar-Lucander’s unique path in science

BPR: Could you give us an overview of your work? I joined Calliditas Therapeutics as CEO in 2017, and in this role I have led the company from a small team of just 10 people to an international biopharmaceutical company with over 200 employees. Calliditas is now a successful commercial-stage biopharma company with a pipeline…

Montreal miniseries – startup AFX Medical’s brainchild

Lonza unveils AI-powered route scouting service for small molecule development

Has the battle against antipsychotic weight gain been won?

Wendy Cheng on global AI regulation in pharmaceuticals

Wendy specializes in applying advanced methodologies to address complex healthcare research challenges and has used machine learning and other predictive modelling techniques, including latent class analysis to identify cost clusters in disease patient populations, and group-based trajectory analysis to identify disease prognosis patterns. Can you provide insights into the current global regulatory landscape governing AI…

Adapting to regulatory shifts and market demand

BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business? Our new APS-qualified manufacturing facility aligns with Annex 1 compliance standards, which are critical for clients targeting European markets, while also meeting the highest quality standards for U.S. markets. Unlike older facilities undergoing retrofitting to meet these standards,…

Platform integrates formulation development and on-demand GMP manufacturing

OSP caught up with them before the event, which is taking place in the Pennsylvania Convention Center, Philadelphia, between May 7-9. How does your company stay ahead of industry trends and developments in the pharmaceutical sector? Quotient Sciences is built on our three foundational pillars of science, agility, and culture. We’ve always maintained that a…

Potential for Astellas’ new prostate cancer drug with EC approval

“The extended approval allows enzalutamide to be administered either as monotherapy or in combination with androgen deprivation therapy (ADT) for adult men with high-risk biochemical recurrent (BCR) nmHSPC who are unsuitable for salvage-radiotherapy,” said president and CEO of Astellas, Naoki Okamura. “This approval is based on results from the phase 3 Embark trial in 1,068…

Women in Science Wednesday – Karen Ooms’ journey to Quanticate

She works as joint chief operating officer at a specialist biometrics CRO called Quanticate where she looks after the programming and statistics functions. Could you give us an overview of your work? My role is rather broad but roughly falls into the following categories, although every day is unique! Ensuring that the needs of our customers…

on industry trends and bringing new treatments to market

We caught up with the company once more and put a few more questions to CEO Sebastian Coppe about the forthcoming CPhI North America being held from May 7-9 at the Pennsylvania Convention Center. As a company which has launched to address strategic challenges in the biopharma industry today, where do you see the value…

An interview with LGM Pharma

Elevating healthcare product launches through smart data

Inizio Engage, a life science consulting firm, is aiming to address this challenge through its data-driven and evidence-based methodology. Duering a presentation at Reuters Pharma USA, Mike Stout, president, US commercial, and Sese Abhulimen, president, global decision optimization, outlined how the company is focused on optimizing brands and accelerating impact using data. “We want to…

WuXi AppTec strongly denies sharing clients’ data with Beijing

It has been widely reported that in early February US intelligence officials told senators working on a biotech security bill, off the record, that WuXi AppTec had transferred the US intellectual property without consent according to two sources. Reuters reported that a classified briefing to several senators was led by the FBI, the State Department,…

Oncimmune ventures into age-related disease biomarker research

The company says its renowned ImmunoINSIGHTS platform is recognized for its prowess in antibody marker discovery and will now be used to unearth novel biomarkers associated with ageing and age-related conditions. It says this will underscore Oncimmune’s unwavering commitment to confronting the multifaceted challenges posed by aging, where it aims to play a key role…

Vivalink and RSRT to accelerate treatments for Rett syndrome

The collaboration marks a significant stride towards shifting symptom assessment paradigms in Rett syndrome through the use of cutting-edge wearable technology. Rett syndrome manifests with a range of challenges including speech impairments, motor skill deficiencies, and autonomic dysfunction, impacting vital functions such as breathing patterns, heart rate variability, and sleep. To address the critical need…

Momentous CE marking for life-saving device

This achievement marks a significant milestone in the company’s journey, granting European Union medical providers access to a life-saving device and highlighting the company’s global expansion efforts. The CE marking was granted under stringent European Medical Device Regulations, signifies the approval of the COBRA-OS as a safe and effective medical device for aortic occlusion. Notably,…

Ultrahuman launches US smart ring manufacturing facility

It is now poised to become the first facility in the United States dedicated to producing wearable rings. This strategic move comes hot on the heels of a recent $35 million investment, propelling Ultrahuman towards the top of the smart ring market. Located in Indiana, the UltraFactory is set to start operations within the next six…

‘We are all about making sterile supply simple’

BPR: What new products or innovations is your company showcasing at CPHI North America this year? We are a CMO focused on supporting the needs of clients looking to bring terminally sterilised injectables to market. For the US in particular in 2022 48% of all drug shortages related to injectable medicines. The ability to ensure a…

How Biosynth is coming to CPHI North America with an ‘even bigger toolbox’

BPR: What new products or innovations is your company showcasing at CPhI North America this year? With the new acquisitions over the past 2 years, Biosynth comes to CPHI North America this year with an even bigger tool box. Along with our novel chemiluminescent and fluorescent small molecule enzyme substrates, two of our newest and…

Growing mini trees – exploring QS-21, the vaccine adjuvant

We delved into the fascinating world of vaccine adjuvants, particularly focusing on QS-21, a purified plant extract derived from the soap bark tree (Quillaja saponaria) indigenous to Chile, Peru, and Bolivia. Known for its potential in boosting vaccine effectiveness, QS-21 contains water-soluble triterpene glycosides, a type of compound called saponins, which are believed to enhance…

Women in Science – Katrina Rice on making the world a little better

As chief delivery officer, biometrics services at eClinical Solutions, Katrina is driving clinical data transformation, and building a thriving services organization equipped to address growing trial complexity and accelerate cycle times through end-to-end data strategies and practical innovation. Could you give us an overview of your work? As eClinical Solutions’ Chief Delivery Officer, Biometrics Services,…

Test that can enhance the likelihood of identifying colorectal cancer produced by Mainz Biomed

Mainz Biomed has been manufacturing ColoAlert which is a non-invasive mt-stool DNA screening test designed for early detection of cancer. OSP wanted to know more about this potentially life-changing and life-saving test and sat down with Mainz to find out more. OSP: What is ColoAlert and how does it function in the detection of colorectal…

Against animal testing in pharma? See what the industry says

The company said its project represents a significant investment of $200 million over the past four years, with an additional $300 million earmarked for the next five years. In what it has called a comprehensive investment strategy, Charles River said it encompasses a range of technological innovations, strategic partnerships, and advocacy efforts all geared toward…

Giving the gift of health by finding solutions to the cost and complexity of prescription drugs

The company was founded by healthcare technology startup veteran John Romano, and the company launched a pilot program in Ohio and quickly expanded into all 50 states. Today, the team has grown to include technologists, data scientists, patient advocates, and path-to-purchase experts and the company’s purpose is simple: to help people get the prescribed care…

LGM Pharma to meet growing demand in geriatric and pediatric areas

As the company will be attending CPhI North America, OSP caught up with Hamilton Lenox, senior vice president of business development and operations. How does your company stay ahead of industry trends and developments in the pharmaceutical sector? LGM remains at the forefront of industry trends and developments in the pharmaceutical sector by prioritizing customer…

world’s fifth leading killer by 2040 if left untreated

Following on from this news, OSP put several questions to the pharma giant to dig deeper into the study. Can you provide more insights into the methodology used in the IMPACT CKD study, particularly regarding how the modeling analysis was conducted and the data sources utilized? The IMPACT CKD microsimulation model simulates chronic kidney disease…

The doors have opened at Thermo Fisher Scientific’s new innovation hub

The state-of-the-art facility will be an innovation and co-creation/working lab that supports the creation, testing, and validation of new services and products that help advance clinical trial research. OSP interviewed Sarah Englert, the senior director of innovation and program management (pictured) about what the lab means to the company and what it hopes to achieve. OSP:…

A new weapon against gonorrhoea

These findings, set to be showcased at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global event in Barcelona on April 30, 2024, mark a significant advancement in combatting the escalating challenge of gonorrhoea, particularly concerning drug-resistant strains. In the trial, gepotidacin demonstrated a robust microbiological success rate of 92.6%, showcasing its non-inferiority…

Pharma embraces combined PV solutions IQVIA study reveals

In her current role as senior director of integrated pharmacovigilance (PV) solutions, she provides senior leadership and oversight to the safety tech-service integrated offering delivery combining IQVIA’s expertise both from a technology and service perspective focusing on accuracy, efficiency, compliance, standardization, and automation. Here she discusses a recent study and how PV is managed by…

Charles River – looking for alternatives to animal testing

The project represents a significant investment of $200 million over the past four years, with an additional $300 million earmarked for the next five years. This comprehensive investment strategy encompasses a range of technological innovations, strategic partnerships, and advocacy efforts all geared toward reducing reliance on animal testing. “Advances in science and technology have brought…

Qinecsa acquires Insife to elevate pharmacovigilance tech

This strategic move, the company says, aligns with Qinecsa’s vision to emerge as the premier provider of digital pharmacovigilance solutions. With a strong focus on innovation and excellence, Qinecsa says it has earned a reputation as a trusted global partner in pharmacovigilance. With platforms like Reportum and CVW, Qinecsa believes it empowers life science companies…

AstraZeneca’s Impact CKD study: Alarming projections for 2032

The study forecasts that by 2032, up to 16.5% of the population in these countries could suffer from CKD, with a staggering rise of up to 59.3% in advanced-stage cases. Ruud Dobber, executive vice-president of AstraZeneca’s BioPharmaceuticals business unit, stressed the gravity of these projections, stating, “Our modelling emphasises the enormous impact CKD could have…

The key to getting pharma trials up and running

OSP spoke to Frontsin about why the CROs are under greater pressure to deliver measurable results quickly at lower costs. He said the company’s growth initiative enables CROs to evaluate the power of Oracle technology with their potential sponsors. As part of the CRO Growth Initiative, many CRO professionals have also taken advantage of the program’s…

Rare primary immunodeficiency drug trial’s enrollment complete

Leniolisib, marketed as Joenja in the US, obtained FDA approval in March 2023 for treating APDS in adult and pediatric patients aged 12 and above. Pharming aims to incorporate data from this trial into global regulatory submissions for leniolisib’s pediatric approval for APDS, starting in 2025. Anurag Relan, chief medical officer of Pharming, said: “This…

Medicxi invests $40m in D3 Bio, enhancing oncology pipeline

The investment will accelerate the development of D3 Bio’s pipeline of oncology compounds, particularly its lead asset DS3-001. D3S-001 is a new generation small molecule KRAS G12C inhibitor with differentiated properties and could potentially address the large unmet need of patients with cancers harboring KRAS G12C mutations. The treatment is currently in phase 2 development…

Andreas Raabe – carving out a niche for Adragos Pharma

Andreas Raabe, the visionary CEO behind Adragos Pharma, shares his insights into the company’s recent expansion and strategic objectives. With a background in biology, Raabe embarked on a mission to transform the CDMO landscape, aiming to carve out a niche for Adragos Pharma as a dynamic and agile player in the pharmaceutical industry. Reflecting on…

Selkirk’s rises to manufacturing biologics challenges with expansion

Founded in 2018 by a group of industry veterans with diverse expertise, the company has swiftly carved a niche for itself in the fill/finish segment of pharmaceutical manufacturing. With a relentless focus on reliability and a commitment to excellence, the company says it is poised for a significant expansion that will not only bolster its…

Is the headache over for migraine sufferers?

The National Institute for Health and Care Excellence (NICE) has endorsed atogepant, a novel oral medication, as a preventive treatment for both chronic and episodic migraines. This recommendation is poised to change migraine management for up to 170,000 individuals across England. Atogepant, also known as Aquipta and produced by AbbVie, represents a major shift in…

Hope for Fragile X Syndrome: Zatolmilast granted Orphan Status

This was announced yesterday (April 12) by the executive officer, Isao Teshirogi, of Shionogi BV, the European subsidiary of Shionogi & Co., Ltd. Pete Richardson, managing director, UK Fragile X Society, said: “FXS is a frequently misunderstood condition and too often individuals and families struggle to gain access to the support they need from health…

Experts hail Cystic Fibrosis drug for babies and children a breakthrough

This discovery marks a significant moment for Cystic Fibrosis treatment, with experts hailing it as a breakthrough. Lead researchers have emphasized the monumental nature of this finding, especially as it pertains to the treatment of Cystic Fibrosis in infants. The drug, Ivacaftor (Kalydeko), originally formulated for adults, has gradually gained approval for use in younger…

Recent pharma industry appointments that should be on your radar

By Isabel Cameron and Liza Laws 11-Apr-2024 – Last updated on 11-Apr-2024 at 12:27 GMT Facebook Twitter Linkedin Email to a friend Related tags Pharma industry appointments People on the move Pharmaceutical industry Bio Pharma Reporter and Outsourcing Pharma is back with our latest instalment of movers and shakers – breaking down all the key…

FDA’s thumbs up for Prenosis’ AI for sepsis: a game-changer?

Prenosis, a player in the realm of health technology, has secured this milestone with the full authorization of its diagnostic software, which it says marks a watershed moment in the field of healthcare innovation. Sepsis, a grave medical condition triggered by the body’s heightened response to infection, has long posed quite a challenge to healthcare…