Medicine Archives - Page 3 of 4

Elisa Cascade on why women should never be afraid to ask

OSP: Could you give us an overview of your work? With more than 30 years of experience in the clinical research industry with a focus on using technology to transform clinical research for all stakeholders, I sit on the Advarra Executive Leadership Team and serve as Advarra’s Chief Product Officer. In this role, I am…

Andaman7 unveils AI-powered health record update

This update introduces three new AI tools geared towards providing patients with deeper insights into their health records, thereby enhancing communication and understanding between patients and healthcare providers or researchers. The new AI tools integrated into Andaman7 v5 include Simplification, Summarization, and Translation. Simplification utilizes AI to convert complex medical terminology into easily understandable text…

Can NHS England and Gilead Sciences eradicate hep C by 2025?

This partnership aims to eliminate hepatitis C by 2025, aligning with global efforts to eradicate the virus and improve public health outcomes. Since its inception in 2019, the Strategic Procurement agreement between Gilead, NHS England, and various stakeholders has made significant strides in treating and curing hepatitis C. Over 84,000 individuals have benefited from this…

Step forward in Scotland for endometrial cancer treatment

Clinicians in Scotland can now administer dostarlimab in conjunction with platinum-containing chemotherapy for adult patients diagnosed with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer, who are suitable candidates for systemic therapy. With approximately 740 new endometrial cancer cases reported annually in Scotland, an estimated 240 of these cases progress to…

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…

FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension patients

It is the first and only once-daily single-tablet combination therapy by the US Food and Drug Administration (FDA). OPSYNVI combines macitentan, an endothelin receptor antagonist (ERA), with tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a streamlined treatment option for adults with PAH. PAH, characterized by the narrowing of small pulmonary arteries and elevated blood pressure…

Beacon Biosignals expands sleep analysis capabilities

This milestone marks a significant expansion of Beacon’s analysis platform, extending its application from at-home sleep monitoring to comprehensive coverage of traditional in-lab polysomnography (PSG). The software, developed by Beacon Biosignals, automatically stages sleep from electroencephalogram (EEG) signals of clinical PSG recordings. This advancement promises to aid in the diagnosis and evaluation of sleep and…

How can the industry overcome real-world data integration challenges?

Q: How has the use of data evolved in clinical trials and what are the challenges that the industry is facing in this area? Data is the lifeblood of the pharmaceutical industry. Data integration from a myriad of sources supports many important areas of research – from trial site identification, patient finding and eligibility and…

Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’

We sat down with Dr Laura to find out the origins of her fascination with science, the importance of effective communication and how she fosters a diverse working environment. OSP: Could you give us an overview of your work? As vice president of research at CluePoints, I support a team of research scientists responsible for…

More from Pluss as it launches Celsure XL VIP pallets

The company is aiming to transform pharmaceutical shipping and storage standards worldwide. Engineered to meet the evolving needs of the global pharmaceutical market, Pluss promises these VIP pallets provide unmatched reliability, affordability, and sustainability. The company says the pallets are meticulously crafted using ‘premium materials and feature cutting-edge vacuum-insulated panel (VIP) technology’ combined with phase…

Trialbee -on a mission of improving patient recruitment

During the successful SCOPE Summit held in Orlando earlier this year, OSP was delighted to catch up with Matt Walz, who is CEO of the company that gets patients from referrals through to clinical trials using its Honey platform. OSP: Can you provide an update on Trialbee since we met at the last conference? MW:…

Using AI – SimBioSys and General Inception’s cancer pact

The collaboration, announced today (April 3), is poised to leverage advanced AI and biophysical modeling to gain deeper insights into tumor biology and accelerate the creation of safer and more effective cancer therapies. “We’re excited about this collaboration because all new oncology drug incubations under General Inception will be able to use SimBioSys’ state-of-the-art PhenoScope…

Vox Pop Pharma – the industry speaks

The news that broke yesterday (April 3) confirmed the collaboration’s aim to speed up the creation of safer and more effective cancer therapies and saw responses come in from across the pharma sector. Let’s hear what they had to add to the story. Dr Jo Varshney, CEO, and founder of VeriSIM Life, says: “Based on…

More from Pluss as it launches Celsure XL VIP pallets

Molecure’s 2023 milestones and what lies ahead

The company wantd to share some of its highlights and significant advancements in both clinical and preclinical programs. The company aims to continue its momentum into 2024 and 2025 with robust research initiatives. In a statement, Marcin Szumowski, CEO of Molecure S.A., emphasized the exceptional progress made during 2023. “Last year was an exceptional year…

HUTCHMED & Innovent Secure NDA for cancer combo in China

The drug is intended for the treatment of advanced endometrial cancer and the news carries significant weight as it comes with Priority Review status, underscoring the potential impact of this therapeutic approach in addressing a critical medical need. “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.…

Bora Pharmaceuticals acquires Upsher-Smith from Sawai and Sumitomo

With this acquisition, Upsher-Smith now operates as a wholly-owned subsidiary under the Bora Group umbrella. Bobby Sheng, chairman and CEO of Bora Group, assumes the position of chairman for Upsher-Smith, while Rich Fisher, COO and president of Upsher-Smith, remains in charge of day-to-day operations, reporting directly to Mr. Sheng. Mr. Sheng emphasized the strategic significance…

Quibim AI: Revolutionizing liver disease diagnosis

The device is aimed at transforming the diagnosis and management of diffuse liver diseases through advanced AI-driven MRI analysis. The company announced the product launch, which has received CE and UKCA marks for use in the European Union and the United Kingdom, marking a significant milestone in liver disease diagnostics. Chronic liver diseases pose a…

Enhancing AI in the clinical trial landscape

OSP: Could you start by sharing a bit about your background and how you got involved with Cluepoints? PH: Certainly. We established the company in 2012, and over the years, especially in recent times, we’ve seen significant growth in the adoption of risk-based quality management (RBQM) and associated statistical AI and machine learning software within…

Denmark and NVIDIA aiding innovation across multiple sectors

At the heart of this initiative lies the deployment of one of the world’s most powerful AI supercomputers, signaling a significant leap forward in research and innovation across diverse fields, including healthcare, life sciences, and environmental sustainability. The partnership, lead by the Novo Nordisk Foundation and the Export and Investment Fund of Denmark (EIFO), signifies…

Partnership announced to advance personalised medicine

This is intending to advance the development of personalised medicines, improve drug efficacy and outcomes in patients with specific chronic disorders by combining dose-optimised drug therapy with digital care. Dr Paul Goldsmith is chief medical officer and innovation officer, co-founder and president of Closed Loop Medicine. He said: “As clinicians, we know that dosing of…

This week’s woman in science

From math hater to a leader in clinical data, it’s been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar. She tells us how she discovered her love of statistics, why honing her craft has fed her passion to make a difference, and that she will never pull the…

The trial has started – can psychedelics help with alcohol addiction?

The trial, already underway at King’s College London, will now expand to include Clerkenwell Health’s research facility near Harley Street, London. It is focusing on evaluating the safety, tolerability, and pharmacodynamic effects of a novel psychedelic compound, BPL-003, in combination with psychological support tailored for AUD patients. BPL-003, a synthetic formulation of mebufotenin (5-MeO-DMT), promises…

integrating technology to enhance the patient experience

It was an insightful and interesting discussion about feeling close to patients as well as the importance of having a strong female role model and leader. OSP: Could you both introduce yourselves and tell us about your roles at CTM and what drew you to the company? KS: I’m Katherine Seay, the executive vice president…

skip the cliches and focus on the customers

In April 2022, Anju, a leading provider of comprehensive software solutions to the life sciences industry, announced the appointment of Laurence (Larry) Birch as its chief executive officer.Larry brought more than three decades of life sciences, software, and global management experience to Anju, and the company said he was uniquely prepared to lead the company…

Beacon Biosignals expands sleep analysis capabilities

using real-world data to bridge the evidence gap

LL: Before we delve into the specifics of your work at Atropos Health, could you provide a bit more background about yourself and your involvement in tech-enabled trials? BH: Certainly. I’m the CEO and co-founder of Atropos Health. My journey into the realm of health tech and data sciences began during my tenure at Stanford…

how is ICON overcoming real-world challenges?

In an interview he spoke to OSP about data integration and overcoming challenges to optimise clinical trial diversity. OSP: How has the use of data evolved in clinical trials and what are the challenges that the industry is facing in this area? Data is the lifeblood of the pharmaceutical industry. Data integration from a myriad…

Meyos €2.3 million for improving lives of CKD patients

Led by Cenitz and joined by investors including KIMA Ventures, Advans Lab, and Bpifrance, the funding will support Metyos in developing its biowearable sensor and disease management platform. Founded by CEO Alexandre Boulanger and CTO Olga Chashchina, Metyos aims to transform CKD management by providing continuous health monitoring through its technology. Alexandre Boulanger, CEO and…

can it transfrom clinical research?

By integrating various patient-centric outcomes into a single treatment assessment, One2Treat aims to accelerate the delivery of new treatments to the market while reducing trial sample sizes. Traditional clinical studies often focus on a limited number of primary endpoints, neglecting valuable data and failing to capture the full impact of treatments on patients’ lives. One2Treat’s…

Safeguarding emotional well-being through rare disease journeys

The Foundation is a patient-led nonprofit organization dedicated to enhancing access to diagnosis, research, and care for individuals grappling with undiagnosed and ultra-rare diseases. Mary Morlino, a patient navigator deeply involved in supporting undiagnosed and ultra-rare patients through UDNF’s patient navigation program, led this initiative alongside Cristol Barrett O’Loughlin, the founder and CEO of Angel…

FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension patients

eClinical empowering organizations to be more efficient and effective

During SCOPE 2024 in Orlando, Dawn Kaminski, vice president of business development operations at eClinical Solutions, shared valuable insights into the company’s latest innovations and their impact on the industry. Kaminski, with over 25 years of experience in the field, outlined eClinical’s commitment to revolutionizing clinical trial operations through their platform, the eClinical Data Cloud.…

DP World building resilience into healthcare supply chains

This is the company’s approach despite being amidst increasing disruptions to global trade. With 1,000 jobs already created and plans for further expansion, DP World seeks to address the complex logistics challenges faced by the healthcare and pharmaceutical industries. The expansion comes at a crucial time when businesses are prioritizing strategies to enhance resilience in…

myTomorrows collaborates with the ALS Association

myTomorrows is a global health technology company and says it is revolutionizing the landscape of clinical trial accessibility through its original platform. The partnership with the ALS Association underscores myTomorrows’ commitment to ensuring that individuals facing life-threatening diseases have access to all potential treatment options. Under this collaboration, myTomorrows says the ALS Association will make…

What are pharma titans hoping to achieve at this year’s DCAT?

Outsourcing Pharma addressed a number of those attending to produce a ‘written roundtable of what these companies wanted to achieve during this big week in the pharma calendar. Representing a diverse spectrum of expertise and vision, companies Enzene, Adragos, Quotient, Purolite, Tjoapack, Exothera, and Abzena have begun a collective journey with shared aspirations and distinct…

‘British companies investing in the UK should not be headline news’

The news comes after AstraZeneca CEO Pascal Soriot previously branded the UK as a ‘very unattractive’ place to do business. So, what changed and will the cash injection encourage other pharma giants to increase their investment in the UK? “AstraZeneca’s vaccine was integral to the pandemic response in 2020, demonstrating how homegrown innovation can have…

Quibim AI: Revolutionizing liver disease diagnosis

Merck invests €300M in Korea bioprocessing center

This significant investment marks the largest by Merck’s Life Science business sector in the Asia-Pacific region to date and underscores the company’s dedication to expanding its presence in this rapidly growing area. Anticipated to create around 300 new jobs by 2028, this move solidifies Merck’s commitment to fostering growth and innovation in the region’s life…

Lonza to acquire manufacturing site from Roche in major $1.2 billion deal

The site, in Vacaville, California, is one of the largest biologics manufacturing facilities in the world, with a total bioreactor capacity of 330,000 liters. According to Lonza, the move will significantly increase its large-scale biologics manufacturing capacity for mammalian therapies and extend the presence of its facility network in the U.S. The company also plans…

Roquette snaps up IFF Pharma Solutions for $2.85 billion

According to Roquette, the tie-up will ‘rebalance’ its portfolio across health and nutrition, as well as expanding its pharma product portfolio range. It will also expand the company’s position in the ‘attractive’ excipients market and enhance Roquette’s US footprint. “After last year’s acquisition of Qualicaps, today’s announcement is a decisive step in our journey to…

Women in Science – Abzena’s Petra Dieterich on creating new medicines

She has held leadership positions in project management, technical operations, and business development. Working in the CRO and CDMO environment she has led projects for customers across the globe, helping them to achieve their goals in clinical trials and low-volume commercial manufacture. Petra holds a D. Phil in synthetic organic chemistry and an MBA from…

Boost for patients with schizophrenia as BSM completes $14BN deal

This acquisition marks a significant milestone in the healthcare industry, particularly in the field of neuroscience, as it focuses on a potential first-in-class, small molecule muscarinic modulator known as KarXT treatment for schizophrenia in adults, which was invented at PureTech. Eric Elenko, chief innovation officer at PureTech, said: “This acquisition recognizes the enormous potential of KarXT…

FDA takes proactive approach to AI with clear strategy

With a dual focus on fostering innovation and ensuring patient safety, the FDA’s approach seeks to provide regulatory predictability, promote international collaboration, and issue guidance to support the development and evaluation of AI-enabled medical devices and drugs. One of the cornerstones of the FDA’s strategy is international cooperation. Recognizing the global nature of AI development…

Developing angina drug shows promise in trial with no patient headaches

The drug is aimed at treating chronic stable angina pectoris and conducted in Portugal, the exploratory phase 1a pharmacokinetics study, involving 16 healthy adult volunteers, concluded just before the end of last year (2023). The study focused on evaluating the pharmacokinetics of AUX-001, an oral, extended-release, once-daily version of nicorandil, a medication used to treat…

An alternative to Wim Hof’s icy dips? Discover nervous system modulator Nurosym

This approach, along with the increasingly popular practice of cold exposure, is reshaping the pharma and wearable industry’s understanding of how to optimize physiological and mental well-being. Extreme athlete Wim Hof has lauded the potential of these methods, emphasizing their profound impact on human health. Parasym, a pioneering neurotechnology company has introduced Nurosym, a wearable…

Chronic pain clinical trial produces highly encouraging results

The analysis, conducted by York Health Economic Consulting (YHEC), revealed compelling insights into the efficacy and cost-effectiveness of Celadon’s cannabis-based medicines in treating chronic pain. According to the report, patients enrolled in the feasibility study experienced a remarkable 49.6% reduction in pain scores within the first month of using cannabis-based medicines. This significant reduction was…

AION Labs’ CombinAble.AI: AI-powered antibody design redefined

This startup, born out of AION Labs’ startup challenge, aims to enhance the development of biological therapeutics by using the latest AI technologies. The company says CombinAble.AI represents a bold departure from traditional antibody optimization methods, which often involve laborious trial-and-error processes. By embracing advanced machine learning models and computational simulations, AION says the platform…

Women in Science – Maravai’s Kate Broderick’s fascinating story

Could you give us an overview of your work? I am the chief innovation officer at Maravai Life Sciences, the parent company to several life science brands, including TriLink BioTechnologies, Alphazyme, and Cygnus Technologies. I direct the research and development focus for the company and lead where we should be going in the future. Altogether,…

A Conversation with Dave Hanaman

I recently had the privilege of engaging in an enlightening conversation with Dave Hanaman, the co-founder of Curavit. Our conversation covered a wide array of topics, ranging from recent achievements to industry trends and the future trajectory of clinical research. Since our last discussion, Curavit has achieved a series of significant milestones, reflecting what they…

eClinical empowering organizations to be more efficient and effective

eClinical Innovations Streamline Clinical Trial Processes: Insights from Dawn Kaminski In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes. During SCOPE 2024 in Orlando, Dawn Kaminski, vice president of business development operations at eClinical, shared valuable insights into the company’s latest…

AION Labs’ CombinAble.AI: AI-powered antibody design redefined

Urgent need for more epilepsy treatments says Angelini Pharma

Partnering with scale-up Wazoku, Angelini Pharma announced yesterday (March 11) that it aims to make use of the collective wisdom and expertise of its 700,000-strong crowd to drive innovation in epilepsy treatment. The challenge, titled ‘New Digital Approaches to Target Discovery in Epilepsy,’ marks the beginning of a strategic collaboration between Angelini Pharma and Wazoku.…

Cresset expands North American presence with new Boston site

The company has taken a significant step towards its international expansion by establishing a new facility in Boston, which is said to be one of the world’s premier hubs for pharmaceutical and life sciences industries. Operating from its headquarters in Cambridge, UK, Cresset has emerged as a global player in drug discovery solutions, with more…

Negev Capital celebrates psychedelic medicine milestones across globe

It says three of its companies have recently made groundbreaking achievements including Beckley Psytech, Filament Health, and MindBio Therapeutics. With this side of the industry developing rapidly and many claiming 2024 could be a watershed year for the sector, this pipeline of advanced clinical milestones and regulatory approvals in major markets including the US. “We…

Insights from Medable’s Colin Weller

The purpose of the discussion was to delve a bit deeper into the challenges and advancements in the pharmaceutical industry, particularly regarding the use of digital technologies in clinical trials. Colin’s background, industry frustrations, the impact on patients, and the future direction of clinical trials were just some of the subjects tackled. When asked about…

James Riddlle of Advarra shares insights on clinical trial engagement

James Riddle, the company’s senior vice president of global review services operations, shares valuable insights into the company’s vision and its impact on the healthcare industry. Throughout his conversation with senior editor of Ousroucing Pharma Liza Laws, a deeper understanding of the importance of engagement in clinical trials and the strategies employed to optimize participant involvement…

Metabolon introduces ‘groundbreaking’ bioinformatics platform

The announcement was made at Biomarkers UK, and it was used as an opportunity to showcase Metabolon’s latest platform designed, the company says, to propel the landscape of metabolomics analysis. Drawing on more than two decades of industry-leading experience, Metabolon says it now boasts an established database of more than 5,400 biologically relevant metabolites, the…

Medidata’s data-driven solutions to enhance patient experiences

They discuss their roles and experiences and how Medidata handles clinical research. The conversation covers topics ranging from patient engagement to technological advancements, highlighting the importance of human touch in clinical trials and the integration of data-driven solutions to enhance patient experiences. LL: Just to kick things off, could you both introduce yourselves and explain…

ClinOne launches enhanced self-service platform

This expansion, powered by True Software as a Service (SaaS), introduces advanced self-service configuration management capabilities, empowering users to streamline clinical trial setup and management like never before, ClinOne says. This seminal development, the company says, signifies a significant shift in the clinical trial landscape, putting the power directly in the hands of customers to…

Almac Group expands facilities to meet growing client demand

These expansions cater to the rising demand for commercial manufacturing, packaging, and peptide production, bolstering the operations of its business units, Almac Pharma Services and Almac Sciences. The first facility, spanning 32,000 square feet, is a custom-built high-volume plant for Almac Pharma Services, significantly amplifying the capacity for commercial manufacturing and packaging of sachet drug…

Slope at SCOPE – has the sample management revolution only just begun?

During SCOPE 2024 held in Orlando, he shared insights into the complexities of sample management and data reconciliation, alongside precision medicine, shedding light on the challenges faced by teams in the industry. The company, a provider of solutions for sample and data management in clinical trials, also unveiled its progressive tools aimed, it says, at…

Parents inspire dementia-friendly finance app

This investment is poised to propel financial inclusion and equality for those navigating the challenges of dementia. It is geared towards assisting individuals living with dementia in managing their everyday finances, Hailing from Southampton, Jayne thought about the idea for Sibstar while caring for her parents, both grappling with dementia. Her appearance on the show…

How curiosity and determination inspired Hayley Crowe’s journey from bench to c-suite

BPR: Could you give us an overview of the work that you do at Purolite? What do you oversee at the company? I’m excited to share that we recently combined our life sciences business with our Purolite business – so I now have a global life sciences business, which is a new endeavour! However,…

Form Bio and Gingko Bioworks join to accelerate drug development

This collaboration integrates Ginkgo’s licensable assets and manufacturing capabilities with Form Bio’s cutting-edge AI-driven solutions for gene therapy optimization. The partnership offers a comprehensive solution for gene therapy developers, streamlining product optimization and accelerating the journey from lab to clinic while conserving resources. By combining Form Bio’s in silico solutions with Ginkgo’s AAV products and…

Veterans’ charities rally to help find volunteers for PTSD trial

To find the 40, it will need to screen up to 1,000 people which is why several leading veterans’ charities have joined forces for this mission. Charities including Head Up and re:mind are joining MQ Mental Health Research in seeking ex-service personnel who might benefit from an innovative treatment, combining the use of an investigational…

Drug discovery key to Cresset and Enamine partnership

The partnership aims to champion innovative solutions for the early stages of the drug discovery process. The companies will focus on the development of revolutionary technology to facilitate the screening of ultra-large chemical spaces during the virtual screening process in drug discovery. Virtual screening involves searching libraries of small molecules to identify structures most likely…

Medidata’s data-driven solutions to enhance patient experiences

Survey uncovers several critical factors motivating physicians

They are across diverse therapeutic areas regarding their participation in clinical trials, challenges faced, and the status of digitalization within the field. The survey uncovered several critical factors motivating physicians to engage in trials, with 80% of them citing a significant emphasis on advancing scientific knowledge, 55% gaining early access to novel treatments, and 55%…

ICON’s Kathleen Mandziuk drug development journey

She explains how the intense experience now gives her a new sense of pride and dedication to the transformation of healthcare and clinical research as she takes us on her journey to clinical research and drug development at ICON. Could you give us an overview of your work? I lead an incredible team of experts…

Proscia partners with Pramana to enhance digital pathology solutions

This partnership marks Pramana’s integration into the Proscia Ready partner alliance, aimed at empowering life sciences organizations and diagnostic laboratories with enriched, high-quality data, including DICOM images, for enhanced research and clinical operations. The Proscia Ready initiative, established to expedite the widespread adoption of digital pathology, offers laboratories the flexibility to choose from a range…

Emmes submits Duchenne video assessment qualification plan to FDA

The company has officially submitted its Duchenne Video Assessment (DVA) qualification plan to the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) for thorough review. This submission marks a significant moment not only for Duchenne muscular dystrophy (DMD) research but also for the utilization of video assessments as primary endpoints…

New innovation hub launched by RSSL

This dedicated platform aims to bolster small- and medium-sized biotech organisations by providing them with essential resources and support to expedite the development of cutting-edge products. Jacinta George, managing director of RSSL, expressed the company’s vision, stating: “Our goal is to drive vital research and support innovation across the entire life science sector.” The Innovation…

Radboud University – finding the best way to diagnose rare diseases

Deploying genomic technologies helps researchers to better understand the causal mechanisms of diseases improving the accuracy of diagnoses which can help offer patients and their families a possible direction for the future. According to the US National Institute of Health, an estimated 7,000 rare diseases collectively impact between 3.5% to 5.9% of the global population.…

First participant dosed in phase 1 clinical trial for RXC008

The company focuses on discovering and developing small-molecule, targeted therapeutics for the treatment of fibrotic disease and cancer. RXC008 is a wholly owned gastro-intestinal (GI) targeted Rho-associated coiled-coil containing protein kinase (ROCK) inhibitor, being developed as a potential first-in-class treatment for patients with fibrostenotic Crohn’s disease. The primary objective of this first-in-human study is to…

Global biotech, Lifebit, achieves significant milestone

The company says this achievement signifies a major advancement in research and development capabilities within the pharmaceutical industry, driven by the federated data partnerships forged by Lifebit. In an era where traditional drug development processes are characterized by sluggishness, exorbitant costs, and inefficiency, Lifebit says its milestone is a beacon of hope. The company says…

Biogen’s positive step for ALS and neuromuscular disease patients

As a result, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Qalsody (tofersen). This recommendation is for the treatment of adults with ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If approved by the European Commission (EC), Qalsody will mark…

ICON’s Kathleen Mandziuk drug development journey

Survey uncovers several critical factors motivating physicians

join our panel of industry experts

Gone are the days when oral methods were the primary means of administering medication. Today, continuous innovations have expanded the arsenal of delivery methods to include implants, patches, syringes, and various solutions for transdermal, topical, and oral systems. These advancements not only cater to diverse health needs but also address the challenges posed by an…

Genuinely exciting phase 3 results for CymaBay’s seladelpar

CymaBay Therapeutics, Inc., a biopharmaceutical company focusing on innovative therapies for liver and chronic diseases, recently (Feb 21) announced the publication of detailed results from the RESPONSE phase 3 trial in The New England Journal of Medicine (NEJM). The trial evaluated seladelpar, an investigational agent and the only potent, selective peroxisome proliferator-activated receptor delta (PPARδ)…

uMotif and MoCA collaborate to deepen commitment to CNS research

This collaboration aims to streamline the process of capturing cognitive function and eCOA/ePRO data, marking a significant milestone in the field of neurological research. uMotif CEO Steve Rosenberg. In announcing the partnership with MoCA Cognition, uMotif CEO Steve Rosenberg explained: “The goal is to bring sponsors, CROs, sites and patients the combined power of modern…

Artax announces first patient dosed in psoriasis treatment trial

According to the National Instituye of Arthritis and Musculoskeletal and Skin Diseases, psoriasis is a chronic, long-lasting disease in which the immune system becomes overactive, causing skin cells to multiply too quickly. Patches of skin become scaly and inflamed, most often on the scalp, elbows, or knees, but other parts of the body can be affected…

Rare diseases interview with Clincierge’s CEO, Scott Gray

It was created by The European Organization for Rare Diseases (EURORDIS) to bring together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers and their families. In advance of the day, OSP spoke to president and CEO Scott Gray, of Clincierge, a patient logistics management company about treatments, collaborations and the…

Innovative Trials partners with Oliver Patch Project for trial retention

Brian Burkhardt began the Oliver Patch Project in 2020 after his son, Oliver, was diagnosed. Children going through treatment can receive regular patches, uniquely designed by artists, to keep them motivated and focused on staying positive throughout their treatment journey. More than 35,000 patches have provided support to thousands of children and teenagers in each…

AstraZeneca’s Tagrisso approved as an important new treatment option

AstraZeneca’s small molecule Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 phase 3 trial published in The…

Doctor at Mendel AI invents a Google for medical records

Going many steps further than just reshaping technology, Dr Karim Galil has been a big part of creating a platform likened to the ‘Google for medical records’. Throughout modern medicine, the journey towards innovation and progress often stems from personal experiences and the desire to end human suffering. Driven by a profound understanding of the…

From Principal IRB to Univo

It is a next-generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies. The company is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials. At last week’s SCOPE Summit…

OVID Health’s initiave rewarding companies’ patient-centricity launches

Health communications consultancy, OVID Health made the announcement today (February 22) that the only Patient Partnership Initiative (PPI) is marking its half decade of the program that shares and celebrates best practices in partnership working towards raising standards across the whole industry. “We are thrilled to reach this milestone of the fifth anniversary of the…

NICE guidance recommends GSK’s Omjjara as treatment option

It can also be used as a treatment for symptoms in adult myelofibrosis patients with moderate to severe anaemia. Myelofibrosis, a rare blood cancer characterized by bone marrow scarring, affects approximately 1,970 individuals across England, Wales, and Northern Ireland. Momelotinib marks the first JAK-inhibitor treatment available in England and Wales for both newly diagnosed and…

Clerkenwell Health’s psychedelic drug trial seeks participants

With treatment-resistant depression, standard solutions aren’t enough. They might not make an impact or your symptoms may only improve temporarily. Now, an international clinical trial is investigating a novel synthetic formulation of the psychedelic substance 5-MeO-DMT, also known as Mebufotenin, for Treatment Resistant Depression (TRD). The trial has now expanded into a new London location…

Women in Science: Sygnature Discovery’s Jane Kendrew

She is now director of translational oncology, at Sygnature Discovery. OSP interviewed Jane to find out more about her career journey – from school to where she is now. Could you give us an overview of your work? As a department, we work with academics, biotechs and large pharma to support critical aspects of their drug…

Florence Healthcare and Slope join forces to strengthen processes

The companies say uniting will address research site demand for end-to-end solutions to increase efficiencies across all trials. Slope is a global clinical trial execution platform for sites used by more than 75% of NCI-designated cancer centers for inventory and sample management. Florence Healthcare is a site enablement platform used by over 18,000 connected research…

Arvinas doses first patient with previously undruggable disease

Arvinas Inc. is using its first oral PROTAC, or PROteolysis-TArgeting Chimera, protein degrader in development to treat neurodegenerative diseases. In preclinical studies, the ARV-102 PROTAC, has been shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2) which is a large multidomain scaffolding kinase. Increased activity and expressions of LRRK2 is…

Adevărul despre suplimentele de colagen

suplimentele de colagen Colagenul este o proteină care se găsește în piele, oase și cartilaj, iar multe companii susțin că are beneficii împotriva îmbătrânirii. Cele mai populare produse sunt cremele și pastilele care ar trebui să îmbunătățească aspectul pielii ridate, să întărească părul și unghiile, să ajute la sănătatea intestinului și chiar să promoveze pierderea…

AstraZeneca’s Tagrisso approved as an important new treatment option

How Stella Vnook is ‘infusing innovation’ into cell therapies with Likarda’s technology

Having spearheaded the development of companies focused on CAR-T, CAR-NK, and gene-editing technologies, Vnook encountered challenges with CAR-T efficacy on solid tumors, where NK and T cells struggled to maintain their intended targets. Now, Stella runs a company which she believes is able to tackle that exact issue. At Likarda, Vnook leads a team dedicated…

Artax announces first patient dosed in psoriasis treatment trial

Advarra’s single sign-on for sites

Some of the biggest subject areas included overburdened clinical sites along with patient retention. To improve clinical research, these key areas must change. Budgeting and contracting have always been the top burden for sites, but in a new survey, technology jumped to the top for the first time. This is significant. On average, sites are…

dsm-firmenich announces partnership with Zerion for CBD innovation

The company says patients currently have to self-administer large volumes of cannabidiol (CBD) to achieve a helpful therapeutic outcome. The partnership grants dsm-firmenich global access to ZERION AS’s Dispersome technology, developed to significantly increase the bioavailability of oral CBD compared to commercially available CBD oils. The companies say that not only will the collaboration inspire…

Phesi celebrates 100 million global patient data milestone

The company, a provider of patient-centric data analytics made the announcement today (February 6), that this unparalleled volume of data will allow sponsors to access data on patients with more than 4,000 indications, plan more successful trials, and stimulate clinical development activity with a high degree of accuracy. The company says that with such a…

New data from Japan shows early resolution of common Covid-19 symptoms

The trial met its primary and key secondary endpoints, making ensitrelvir the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection. The study found that once-daily administration of ensitrelvir led to a statistically significant reduction in the time to resolution of five typical COVID-19…

Roche pulls plug on camonsertib agreement with Repare Therapeutics

Repare has said that it will take back control its global development and commercialization rights to camonsertib (RP-3500), it says is a potential best-in-class, oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase). Roche notified Repare that, effective from May 7, 2024, it is terminating its agreement for the development of camonsertib following a…

First treatment for Friedreich’s ataxia in Europe granted approval

Omaveloxolone will be the first therapy within the European Union to treat Friedreich’s ataxia (FA) in adults and adolescents aged 16 and over. The company announced yesterday (February 12) that the European Commission has given its approval for the small molecule drug, known as Skyclarys. Sylvia Boesch is the principal investigator of the MOXIe study…

Pharmacies in crisis need Charac’s digital help

Thanks to an injection of funds from private equity firm, Traditum, funds raised are now around the £4 million mark following three earlier funding rounds. The company plans to further enhance its online platform for independent pharmacies and accelerate its growth in the UK and internationally. In January, the government and NHS England launched The…

New appointments in the pharma industry so far in 2024

Related tags appointments People on the move Pharma industry Jobs Outsourcing Pharma and BioPharma Reporter breaks down the key people on the move in the pharma industry. Enhanc3D Genomics, Cytomos and Cellular Origins are among the companies welcoming new faces to top jobs.

Verisense Health adopts Datavant’s data connectivity platform.

The digital health technology and data company made the announcement last week (February 6) that by using the platform, it can link its digital health panel to other real-world data (RWD) sources and further progress objective, digital health research. Verisense Health’s panel captures participants’ longitudinal, raw, wearable sensor data, together with their patient-reported outcomes data.…

IQVIA: Healthcare data regional compliance complexity requires AI, ML and NLP automation

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear.

Good news for Hong Kong as colorectal cancer treatment approved

The announcement was made today (January 30) that there was marketing approval by the Pharmacy and Poisons Board of Honk Kong for the treatment of adults with previously treated CRC with Elunate. The drug is a selective oral inhibitor of vascular endothelial growth factor (VEGF) receptors -1, -2 and -3, which play a pivotal role…

Top minds from pharma, academia and tech to sit on ArisGlobal’s new generative AI council

The Global Council is a small and exclusive top-tier group of AI tech, academia, regulatory agency leaders, and the life sciences (pharma) industry, including Microsoft. The group’s remit is to pinpoint and showcase repeatable use cases that will shape the targeted use of next-generation artificial intelligence and machine learning (AI/ML) innovation, particularly in the form…

Kinnov Therapeutics alcohol use disorder (AUD) drug progressing well

Historically, the recommended treatment has focused on abstinence and achieving complete sobriety. However, having observed this method’s lack of efficacy, Emmanuel de Rivoire, CEO of Kinnov Therapeutics, (pictured below) has agreed to discuss an alternative treatment strategy with OSP. This new approach, he says, aims to reduce levels of alcohol consumption amongst heavy drinkers, through…

use of elC may surpass use of paper consent forms

Medable partnered with Duke University Department of Population Health Sciences Bioethics and stakeholder (BASE) lab for the pilot study that compared participant comprehension and usability, satisfaction, and preference of enhanced elC versus text-only elC. It specifically explored the use of interactive videos, graphics, calendars, and other tools to augment text in an elC form. The…

Pfizer and Arvinas’ jointly develop oral treatment for breast cancer

Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC) ER degrader specifically for estrogen receptor-positive and HER2-negative metastatic breast cancer previously treated by endocrine-based therapy that is being jointly developed by Arvinas and Pfizer. Being developed jointly by Arvinas and Pfizer, the drug candidate is a heterobifunctional PROTAC (proteolysis-targeting chimera) and selective estrogen receptor degrader (SERD)…

Pharmacies in crisis need Charac’s digital help

New appointments in the pharma industry so far in 2024

Rani Therapeutics announces promising phase 1 results for oral Stelara biosimilar

Ustekinumab is a human IgG1қ monoclonal antibody that binds to the p40 protein subunit used by both the interleukin-12 and interleukin-23 (IL-12 and IL-23) cytokines. In the early study with 20 participants, RT-111 was found to be well-tolerated and delivered ustekinumab with high bioavailability. Currently, ustekinumab is available only as a subcutaneous injection (SC) and…

Immunic’s CSO – on exploring the fascinating world of viruses

She loves her job and works within a team that believes in the power of diverse perspectives and robust discussions. Read on to discover how she got to where she is today. Could you give us an overview of your work? As chief scientific officer, I oversee the scientific strategy and preclinical development pipeline for…

Brainomix 360 platform for stroke care endorsed by NICE

Brainomix 360 (formerly known as e-Stroke) helps clinical decision-making in stroke and was among more than a dozen technologies assessed by NICE, a highly respected health evaluator with a stringent evidence-based approach. Its recommendations carry global significance. The company says the NICE guidance elevates the Brainomix 360 stroke platform, the European market leading solution now…

Phesi celebrates 100 million global patient data milestone

finding cancer trial patients like finding needle in haystack

The company recently announced its Omnichannel Network partnership with Massive Bio, a global leader in AI-enabled patient journey mapping platform, to help better connect cancer patients and their oncologists/haematologists to clinical trials. Adamski, senior director of omnichannel solutions, says that because of the difficulty in recruiting for cancer trials the companies are ‘bringing their best and…

Lightship at SCOPE 2024 – and its people first approach to trials

Motivated by a commitment to underserved populations, he joined Lightship to prioritize access, choice, and equity in clinical trials, ensuring no group is left behind. Drawing from roles at institutions like UCLA, USC, City of Hope, and Science 37, Sepehr employs novel and innovative strategies to enhance clinical trials. He holds an MPH from the…

AI trend to continue at SCOPE 2024

She has more than 15 years in the life science technology industry significant experience in the investigator grant administration domain having led and provided oversight to the successful technology adoption efforts for clients ranging from top 10 CROs to small and mid-size Sponsor companies. An early clinical career focused on the psycho-social impact of long-term…

Repare Therapeutics receives $40 million Roche payment

It earned the milestone payment from Roche for developing and commercializing camonsertib (RP-3500 or RG6526), an oral small molecule drug in Roche’s TAPISTRY trial under its worldwide license collaboration. Tapistry is a phase 2, global, multicenter, open-label, multi-cohort clinical trial designed to evaluate the safety and efficacy of targeted therapies or immunotherapy in participants with…

EDETEK platform delivers custom configurable workflows

EDETEK provides clinical technology solutions for the biopharmaceutical, medical devices and CRO companies. The new product forms part of the CONFORM Informatics Platform – Statistical Computing Environment (SCE) which, the company says was built to solve many challenges faced by clinical programmers and statisticians. It features a cloud-native design, modern web-based user interface, ability to…

Stevanato bringing advanced biopharmaceutical products to market

The company announced that the two new solutions for efficient small batch pharmaceutical manufacturing – the EZ-fill Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC). The company says when a context where reducing time-to-market is key, its new EZ-fill Kit offers fast access to an adaptable and versatile…

Evaro secures $1.5 million to transform minor healthcare access

Evaro was founded in 2018 by Thuria Wenbar, an emergency doctor and software developer, and her husband, Oskar Wendowski, a pharmacist, after they discovered that 25% of accident and emergency (A&E) consultations and 40% of GP appointments were focused on minor health conditions. The round was led by Cornerstone VC and Exceptional Ventures, with participation from Catalisi’s investment…

NeoPhore’s small molecule drugs pipeline gets additional £9.6M

Neophore Limited, a neoantigen immune-oncology company, is generating next-generation, immuno-oncology therapeutics to improve clinical outcomes for cancer patients made the announcement today (February 1). The extension of £9.6 million ($12.2 million) had participation from its existing syndicate, CPF managed by Sixth Element Capital, Claris Ventures, Astellas Venture Management, 3B Future Health Fund, 2investAG, and the…

GSK drug for enlarged spleen given UK marketing authorisation by MRHA

The drug is for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Professor Claire Harrison, deputy chief medical officer…

Stevanato bringing advanced biopharmaceutical products to market

Good news for Hong Kong as colorectal cancer treatment approved

IQVIA: Healthcare data regional compliance complexity requires AI, ML and NLP automation

Pistoia Alliance flagship project IDMP-O published

The global not-for-profit alliance advocates for ‘greater collaboration in life sciences research and development and now plans to support the implementation of IDMP-O across the pharmaceutical sector. It is now calling for pharma, technology companies, health authorities, and regulators to register interest in dedicated training programs on integrating IDMP-O into workflows. The ontology is already…

Lokavant’s trial platform – a game-changer in the industry

He says Lokavant’s solution can provide valuable insights to help streamline your trial process and ensure its success. 1.Why do you think it is important to attend SCOPE? Much like our mission at Lokavant, SCOPE provides every major stakeholder in our industry with an opportunity to connect with other innovators and is the perfect event…

Curavit at SCOPE 2024 – on seeing green shoots in the industry

The company uses technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations from wherever they live, work, or study taking away the need for travel. Dave Hanaman serves as president and chief commercial officer for Curavit – a company he co-founded he is an operating partner for…

Medable’s hope – driving down the 12-year drug development lifecycle

The company provides an end-to-end, global cloud platform with a flexible suite of tools that allows sponsors, patients, providers & CROs to work together as a team in clinical trials. The company’s vision is to accelerate the path to human discovery and medical cures. Colin Weller, vice president and general manager of Evidence Platform, he…

SCOPE 2024 – the top space for collaboration across clinical development

The company’s goal is to help life sciences organizations around the world accelerate clinical development initiatives with expert biometrics services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and eClinical biometrics services aim to give clients self-service access to all their data from one centralized location; plus,…

SCOPE 2024 – driving innovation in clinical trials

At the zenith of innovation, OM1 crafts solutions that harness the potential of real-world data and artificial intelligence with solutions like OM1 Aspen and PhenOM. We put some questions to OM1’s Chief Commercial Officer, Shawn Bates in the build-up to SCOPE 2024. Why do you think it is important to attend SCOPE? With uncertainties in…

Breye Therapeutics ApS developing oral ophthalmology drugs

Breye Therapeutics ApS announced today (January 25) that the first patient has been dosed in a phase 1b/2a clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular edema (DMA). The Danish company is a clinical-stage biopharmaceutical company developing new oral therapies for retinal vascular diseases within ophthalmology. Breye is developing…

Partnership to enhance efficiency of development for cancer medicine

The two companies aim to develop the next wave of imaging-based diagnostics for precision medicine. Merck is a leading science and technology company that develops next-generation precision medicine technology targeting a wide range of cancers. The two companies are exploring how to harness the potential of biomarkers and radiomics to predict a cancer patient’s response…

AI trend to continue at SCOPE 2024

Veeva at SCOPE – primary focus will be driving innovation

We put some questions to him in advance of the summit. What are the current top priorities for the clinical research industry? Artificial intelligence (AI) and automation have become priority areas. However, the technology remains relatively unproven because the outcomes of using AI are still to be determined. Most companies are in the early stages…

SCOPE the place to connect and have meaningful chats

The company provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance and is advancing clinical trials to make them safer, smarter, and faster. Why do you think it is important to attend SCOPE? SCOPE’s size and focus on clinical operations – both best practices today and future innovations…

Colleen Acosta – addressing the unmet needs in women’s health

Could you give us an overview of your work? We have a world class team of leaders in the fields of reproductive health and the microbiome. Freya’s drug candidates comprise full-spectrum microbiota and rationally selected strain consortia, which have the potential to restore an optimal, non-inflammatory vaginal microbiome. Freya announced positive topline data from its…

Saama platform users now get instant responses to data queries

The company uses AI and advanced analytics to automate key clinical development processes in a bid to accelerate time to market by taking out manual, resource-intensive processes. For the first time, users can ask questions of their data in natural language, and instantly receive responses – eliminating costly data analysis delays. Additionally, data management and…

Gerresheimer medical device manufacturer expands in Georgia

The expansion will create more than 200 new jobs adding to the 260 it already supports there. The German-based company with a plant in Georgia offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems, medical devices, and solutions for the health and cosmetics industry. The existing Gerresheimer manufacturing facility is already in the…

Clinical Trial Media launches online portal for studies and trials

The company works with pharmaceutical companies through all stages of clinical research made the announcement earlier this month (January 2024). The new portal enables people to learn how to get involved in the research process and get matched with appropriate studies. Clinical Trial Media says this will help its part in bringing critical therapies and…

Luka Yancopoulos, CEO of Grapevine, on data management and supply chains

Luka Yancopoulos is CEO of Grapevine and explains the importance, and challenges, of standardizing data from different sources in order to process it at scale. What are some of the top challenges you see companies facing in implementing data and AI solutions for supply chain visibility? How does Grapevine help address those? Imagine you’ve got a…

SGD Pharma’s goal to become market leader in glass packaging

CEO Olivier Rousseau says that SGD Pharma intends to significantly grow in 2024, with a sustained and consistent approach to its strategies. Underpinning this objective Rousseau outlines the investment achievements already notched up in 2023, which he says illustrates how SGD Pharma has paved the way for this planned growth. He said: “The start of 2023…

GSK’s £200 million investment in the UK and $1.1 billion acquisition

The company formerly known as Glaxosmithkline will put the money towards its sites there until 2025 including constructing new facilities and assembly lines. The company also intends a £67 million revamp of one of its Scottish factories in Montrose with the investment being used to plump up its production of the compounds it uses in…

SmartLabs’ $48 million funding to accelerate scientific development

The company provides flexible laboratory infrastructure and resourcing solutions and welcomed the participation to the funding round from ArrowMark Partners, Winslow Capital Management, and Conversion Venture Capital (CVC2). The company said the Series C financing marks the ‘beginning of the next chapter in the advancement and optimization’ of its laboratory solution portfolio and follows several…

Nitisinone brought to rare disease patients thanks to partnership

The partnership, announced today (January 18) will make NITYR (nitisinone) tablets available for eligible patients in the UK with Hereditary Tyrosinemia Type 1 (HT-1) and Alkaptonuria (AKU). A Free Goods Programme is a compliant way for medicines that are not approved in their country of intended use to be made available for patients who either…

the importance of federal learning for clinical research

He developed a paper on clinical development to proactively address industry issues earlier this month and OSP put some questions to him in a bid to find out more. In the context of accelerating study startup in clinical research and drug development, the integration of Federated Learning (FL) is highlighted as a pivotal advancement. Could…

the need for clearly defined regulatory approval

A tour of a mock home with all the technology in place was certainly eye-opening, so we were keen to follow up on their latest vision outlined in a full report. The company says its main aim is to bring the right care to every person, no matter where they are. It uses AI-driven solution…

Investment of €10 million for drug delivery company DelSiTech

The financing was co-led by new investors DRW Venture Capital LLC, headquartered in Chicago, and Tolmar International Ltd., based in Dublin, Ireland, which together contributed more than €9 million. The remaining financing was funded by existing DelSiTech shareholders. Lasse Leino, chief executive officer at DelSiTech, said: “We welcome DRW and Tolmar to DelSiTech as new…

KBI Biopharma and Argonaut Manufacturing Services form strategic alliance

The companies say the arrangement provides the seamless manufacturing by combining KBI’s leading drug development and biologics manufacturing services with Argonaut’s experience in sterile fill-finish. The alliance reinforces both companies’ commitment to supporting customers in bringing clinical and commercial therapies to patients quickly, safely, and efficiently. KBI and Argonaut say biopharmaceutical organizations are expected to…

Cormica Bradford equipment expansion supporting key client programs

The company says it is known for its ‘unwavering commitment to enhancing patient lives through comprehensive testing services’ and that the investment is a strategic step in supporting key client programs. The expansion includes the introduction of two Agilent 1260 Infinity II LCs – described as a robust high-performance liquid chromatography instrument offering a choice…

Nutriband Inc. signs fentanyl agreement with Kindeva Drug Delivery

Nutriband Inc., a company that develops transdermal pharmaceutical products has signed a commercial development and clinical supply agreement with its partner, Kindeva Drug Delivery. The agreement is for Nutriband’s lead product Aversa Fentanyl. Under the agreement, CDMO Kindeva, will perform commercial manufacturing process development and manufacture clinical supplies for the human abuse liability clinical study…

Medable hopes new technology will cut trial build time by half

The company that provides technology for modern clinical trials says early application of the technology in electronic clinical outcomes assessment (eCOA) deployments – a major delay to study startup industry-wide – is groundbreaking. By automating laborious, manual tasks such as testing, Medable says it saves substantial time and removes eCOA from the critical path to…

Gen Li, president and founder of Phesi on data management

Here’s a summary of our question and answer session. How has the role of data management in clinical development changed? The biopharmaceutical industry has adopted new technologies at an unprecedented pace in recent years. Data from patient records, laboratory research and experiments, clinical studies and scientific publications have all been submitted to digital repositories, giving…

Picodya’s new technology enables real-time monitoring of human immune status

The company is the creator of the first hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) and announced the deployment of its B-Matrix technology in National Institutes of Health (NIH) laboratories. Picoyda says this could further the PREMISE (Pandemic REsponse REpository through Microbial and Immune Surveillance and Epidemiology) goal of establishing a…

MilliporeSigma and ACD/Labs in collaboration for ChemTwins platform

MilliporeSigma’s first release version of its digital reference material (dRM) ChemisTwin provides scientists in quality control labs with an automated structure verification tool by NMR. NMR is an abbreviation for Nuclear Magnetic Resonance. An NMR instrument allows the molecular structure of a material to be analyzed by observing and measuring the interaction of nuclear spins…

Fortrea, Advarra and Veeva form partnership to reduce trial burdens

The partnership aims to deliver an integrated patient- and site-centric solution provoding a smooth and effective clinical trial experience. Fortrea says that because the industry is constantly faced with complex challenges, it wanted to establish an alliance of industry partners, starting with the founding members – Veeva and Advarra, to tackle these challenges head-on. The…

Evotec joins forces with the Crohn’s & Colitis Foundation

The foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis. Under the collaboration, Evotec joins forces with the foundation’s IBD therapeutics incubator program that facilitates collaboration between the Foundation, academic researchers, and industry partners to translate groundbreaking basic research…

WNS on the trials and tribulations of data management

The company says that if business partners are able to harness health date with strong partnerships with the healthcare industry, new use cases will emerge as artifical intelligence (AI) is used correctly and effectively. We put a number of questions to Doctor Gauri Puri who leads the business for life science projects within the healthcare…

Hutchmed’s hope for adults with primary immune thrombocytopenia

The company has announced new drug application (NDA) acceptance in China for its small molecule drug, sovleplenib, and it has also been granted priority review by the China National Medical Products Administration (NMPA). The drug being given to patients who have received at least one previous therapy, sovleplenib is a novel, selective, oral inhibitor targeting…

Luka Yancopoulos, CEO of Grapevine, on data management and supply chains

Nadège Pelletier from childhood microscope to CSO

OSP: Could you give us an overview of your work? As the CSO, I lead Barinthus Bio’s scientific and technical teams in all phases of drug discovery and early development, from project initiation and platform development, up to clinical PD readouts and manufacturing. This is a very exciting time as we do have a few…

New technology could ‘meaningfully impact’ brain trauma

According to the company, its central nervous system (CNS) CAPTON platform improves distribution and proportionate drug activity based on pathology in situ, as well as limiting drug exposure to those areas of the brain suffering pathogenic stress. The chemistry behind the approach involves substituting an essential sulfonate group on suitably configured drugs with an activity-disqualifying…

Where is the industry at with inborn errors of immunity?

Before her arrival, Stefanski was an associate professor of pediatrics at the University of Minnesota and was actively involved in clinical care and research involving children with life-threatening blood and immune system disorders. One of her areas of focus was the use of cord blood units in stem cell transplants and other cellular therapy. She…

ACG joins coveted list of WEF’s Global Lighthouse Network

The company that says it is the largest of its kind, is celebrating the inclusion of its capsule manufacturing facility in Pithampur, India. The WEF’s Global Lighthouse Network (GLN) is a community of manufacturers that shows leadership in using Fourth Industrial Revolution (4IR) technologies to transform factories, value chains and business models, for compelling financial…

Thermo Fisher’s hope to improve outcomes for ARDS patients

The PPD clinical research business of Thermo Fisher Scientific Inc., a world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported phase 2 platform clinical trial to investigate multiple therapeutic options for the treatment of ARDS. BARDA is part of the Administration for…

Thermo Fisher’s hope to improve outcomes for ARDS patients

Newron’s evenamide brings good news for patients with CNS diseases

The company, which focuses on the development of therapies for patients with diseases of the central nervous system (CNS) said the ‘never reported before’ results from its open-label study evaluating evenamide. The company reports the data demonstrated that treatment with evenamide was associated with sustained clinically significant benefits that increased throughout the one-year course of…

Ketamine myths dispelled by clinic following Matthew Perry’s death

Mental health treatment center, the Ketamine Clinics Los Angeles (KCLA) said the storm surrounding the recently announced cause of death for the Friends actor and his reported use of ketamine at the time of his death has prompted its event taking place Friday (January 5) at 1pm PST. Hosted by KCLA co-founders Dr Steven Mandel and Sam…

Ketamine myths dispelled by clinic following Matthew Perry’s death

Calliditas IgAN treatment, Tarpeyo, given full FDA approval

IgAN or primary immunoglobulin A neuropathy is an autoimmune disease that occurs when clumps of antibodies are deposited in your kidneys, causing inflammation and kidney damage. Tarpeyo was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone, it is now the first fully FDA-approved treatment for…

HIV pathology data now reaching investigators within hours

Established in 1994 and funded by the National Institutes of Health and National Cancer Institution has opted to use Proscia’s Concentriq for Research, a provider of digital and computational pathology solutions to encourage scientific exploration and discovery in cancer as well as PLWH. The ACSR says its mission is to ‘acquire, store, and equitably distribute…

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Up to 160 adults with increased risk for acute kidney injury (AKI) following cardiac surgery are planned to be recruited for the study from multiple sites in North America and Europe. The double-blind, placebo-controlled trial is expected to begin early next year and is intended to show that MTX652 protects this high-risk group of patients…

UK approves treatment for hot flushes during the menopause

“Hot flushes and night sweats caused by menopause are common, and can have a significant impact on a woman’s daily life. We are therefore pleased to have authorised Veoza (fezolinetant) for hot flushes and night sweats caused by menopause via our reliance procedure,” said Julian Beach, interim executive director of healthcare quality and access at…

New appointments in the pharma industry

Related tags People on the move Pharma industry Jobs Pharmaceutical industry BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers, shakers and key announcements in the pharma industry. From Stand Up To Cancer, Astraveus and KBI Biopharma, we break down the key changes.

Agno Pharma snaps up Particle Sciences to beef up drug product formulation

The acquisition has added Particle Sciences’ specialized drug product formulation technology to the CDMO’s toolkit in addition to the firm’s development and manufacturing site in Bethlehem, Pennsylvania, with approximately 65 employees. The financial details of the deal were undisclosed. Following the takeover, Agno expects to add more capacity to its drug product formulation and clinical…

The key pharmaceutical trends from 2023 according to industry leaders

There has been no shortage of excitement over 2023 with a huge number of impactful stories. We have seen big funding rounds investments going into pharmaceutical players, such as a $51 million Series B round raised by the Parkinson’s disease player Cerevance in February and an impressive $210 million round raised in September to power…

Five decentralized clinical trial organizations raising big VC cash

As the Covid-19 pandemic raged, lockdowns and strained healthcare systems forced many clinical trials to be delayed or to seek ways to contact patients virtually. However, it was also a catalyst for the adoption of DCTs, which provide a way to bridge this gap. In DCTs, at least some of the trial’s operations take place…

FDA approves Arcutis’ skin foam for seborrheic dermatitis

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

‘Motherhood makes me a stronger, more compassionate employee’

We discussed what drew her to the field, her career up to this point, and what she’s excited to see for the next generation of women looking to join the field. BPR: Could you give us an overview of your work? I am the director of eCOA Science at Clario, a leading healthcare research and…

Anagenex and Nimbus join forces to develop small molecule treatments using AI

According to the deal terms, Anagenex will generate billions of biochemistry data points for each disease target nominated by Nimbus. Anagenex will then use these data to train AI models that can design 100 million new molecules that bind to the targets, and select the best candidates for developing into drug candidates. The therapeutic areas…

FDA approval expands Welireg to patients with renal cell carcinoma

Welireg was originally approved by the FDA in 2021 for a rare genetic condition. The latest approval allows the drug to be used in patients with advanced RCC that have previously received checkpoint inhibitors targeting programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) and blockers of vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).…

Anxiety treated with single dose of psychedelic drug in phase 2b trial

Four weeks after receiving a 100 µg dose of the drug candidate, patients saw a significant reduction in anxiety symptoms compared to a placebo, shown by a 7.6 point drop in the Hamilton Anxiety rating scale (HAM-A). According to the scale, a score lower than 17 signals mild anxiety and 25-30 indicates moderate to severe…

Astellas Pharma’s treatment for hot flashes and sweats approved

Astellas Pharma Inc. made the announcement today (December 11) that the EC, on December 7, approved Veozatm (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Rossella Nappi is full professor of obstetrics and gynecology, chief of the Research Center for Reproductive Medicine and director of the Gynecological…

‘Therapies that hold immense promise may never see the light of day’

We caught up with Dr. O’Neal to discuss the telltale signs of trouble in clinical trials that sponsors can pick up on early and how they can address these issues swiftly to keep their trials on track and effective drugs within reach for patients. BPR: What are common challenges drug developers face during clinical trials?  During…

Lindus Health and Thirty Madison’s pilot dermatology study

Treatments for various skin conditions, including atopic dermatitis (eczema), can be sought via the platform through asynchronous evidence-based consultation, patient-reported monitoring, and provider messaging. Using before and after photos of patients, their progress can be monitored. A study by the National Eczema Association in the US revealed that just under 60% of eczema patients are…

Atropos Health and SEQESTER partner to speed up drug development

Atropos Health translates real-world clinical date into personalized real-world evidence and insights announced its partnership with SEQESTER today (December 14). Healthcare and life science organizations which use the Atropos Health Evidence Network can establish turnkey patient registries to accelerate evidence generation. This process, the companies say, previously costing millions and requiring up to a year,…

Pharma-grade cannabis contracts secured by Celadon

The UK-company is based on the development, production and sale of the medicines and agreed two commercial contracts on May 24 and September 5. The supply of product follows the successful completion of the company’s latest harvest from its UK-based facility, which is being used to fulfil its commercial contracts. Periodic invoicing has now commenced…

Deep Apple’s $52 million funding revolutionizing drug discovery

Deep Apple Therapeutics discovers the therapeutics for high-value targets through virtual screening of artificial intelligence (AI)-generated virtual libraries. With a powerful discovery engine that combines ensemble cryo-EM, deep learning, and molecular docking screens of ultra-large libraries, Deep Apple can go from target identification to lead optimization in less than 12 months – a fraction of…

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

CellCentric gives hope to last-line multiple myeloma patients

UK-based biotech, CellCentric which spun out of Cambridge University has yesterday (December 11) announced new clinical data for the drug at the American Society for Hematology (ASH) in San Diego. The results follow a recent publication in the Cancer Cell journal, which describes the novel mechanism of action of inobrodib, a first in a new…

CEO at Vector Laboratories’ instant passion for science

She discovered a passion for science after her very first chemistry lesson and found the subject came easily to her. To find out more about her and how she overcame the challenges of being the first woman scientist in her lab and finding her way in a male-dominated industry. Could you give us an overview…

Neurological diseases focus of Pharmakure’s alliance with Malaysian university

The company will now work with the faculty of pharmacy at Universiti Teknologi MARA (UiTM) with the partnership focused on advancing research initiatives on the use of machine learning tools to predict Alzheimer’s Disease using blood via academic-industry partnerships. Farid Khan, CEO of PharmaKure, (pictured below right) said: “The UK has an aging population, where…

HIV pathology data now reaching investigators within hours

Phathom’s impending heartburn treatement given NDA by FDA

The company that focuses on remedies for gastrointestinal diseases announced on December 7 that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for small molecule Voquenza as a daily treatment for adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User…