Medicine Archives - Isbark.com

Lantheus acquires radiopharma CDMO Evergreen

The US radiopharmaceuticals giant Lantheus is snapping up the Contract Development and Manufacturing (CDMO) Evergreen Theragnostics as it expands its radiopharmaceuticals business. The deal, which is expected to close in late 2025, is intended to absorb Evergreen’s manufacturing capabilities and radiopharmaceutical pipeline. One of the star attractions is the diagnostic imaging compound Octevy, which is…

Ethris reports positive phase 1 results for ETH47 mRNA asthma treatment

Munich-based biotechnology company Ethris has announced encouraging topline data from a phase 1 clinical trial evaluating its lead messenger RNA (mRNA) candidate, ETH47. The therapy is intended for the treatment of uncontrolled asthma, a condition where asthma symptoms are frequent and disruptive, often due to a virus infection. Targeting the source of uncontrolled asthma The…

Novo Nordisk reports 22% weight loss with amycretin

Novo Nordisk has reported weight loss effects of up to 22% in patients who received a weekly subcutaneous dose of its next-generation weight loss drug, amycretin, over the course of 36 weeks. These topline results show early potential for the drug candidate to surpass the efficacy of Eli Lilly’s Zepbound (tirzepatide), one of its major…

Manas AI launches with $24.6 million seed round

The round was led by the US venture capital (VC) firm General Catalyst Partners with participation from compatriot VC Greylock Partners in addition to strategic investors. Manas will use the proceeds to scale up its AI technology and drive ahead its drug pipeline programs. Manas AI is one of many startups gunning to address the…

Applying data to real-world challenges

Head of solution value at One2Treat, Émilie Barré shares her journey to date with Outsourcing-Pharma. Could you give us an overview of your work? I have recently been promoted to head of solution value at One2Treat. In this new role, I’m ensuring the development of our software solution and strategic services are fully aligned with…

The largest pharma acquisitions of 2024

Compared to the previous years, 2024 has been a relatively slow year for mergers and acquisitions in the pharmaceutical space. The largest acquisition of 2024 doesn’t nearly match Pfizer’s acquisition of Seagen for $43 billion in 2023, or Amgen’s Horizon buyout for $27.8 billion in 2022. In contrast, the year 2025 has already started strong,…

Arctic therapeutics secures funding for groundbreaking dementia and acne treatments

Arctic Therapeutics announced this week that it has raised €26.5 million, a sum bankrolled by investors including the European Innovation Council (EIC) Fund, the Icelandic investment firm Kaldbakur and the strategic player Sanos Group. The company will use the proceeds to carry out a pivotal phase 2b/3 trial of its lead candidate program AT-001, an…

Trial shows high-dose Wegovy can increase weight loss effects

Results from the STEP UP trial show that a high-dose formulation of Wegovy can significantly increase the weight loss effects the drug is known for. Novo Nordisk has announced topline results from the phase 3b trial STEP UP, which investigated the effects of two doses of Wegovy (semaglutide) in over 1,400 patients over the course…

BioCina and NovaCina join forces in merger

Australian contract development and manufacturing organizations (CDMOs), BioCina and NovaCina, have merged in a move to pool their biologic and small molecule production expertise and infrastructure. BioCina, which specializes in process development and manufacturing for microbial, plasmid DNA, and mRNA-based treatments, began its life as Bresagen, a spinout of the University of Adelaide, Australia, in…

AI proving critical in clinical trial design

We ran a Q&A With Michael Young, co-founder of Lindus Health on the challenges of 2024 and the company’s goals for 2025 Achievements and milestones What are the most significant milestones your company achieved in 2024, and how have they impacted your organization or the industry? The most important thing is the trials we’re running…

Spotlight on patient centricity in clinical trials

We ran a Q&A with John Clarke, associate director in patient recruitment at Innovaderm on the changing landscape of patient centricity in terms of clinical trials and how the industry can navigate the evolving regulatory expectations around that. Regulatory expectations How are new regulatory guidelines shaping the way clinical trials are designed to prioritize patient…

Medable Showcases AI-Powered Innovations at SCOPE 2025

Stakeholders across the clinical trials and digital health industry will be gathering next month in Orlando at the Summit for Clinical OPS Executives (SCOPE) 2025. With decentralized clinical trials increasingly gathering attention in the pharmaceutical industry, accompanied by rapid market growth, advancements in this area will be one of the major topics of discussion during…

Tech key to accelerating clinical trial outcomes

Ashley Davidson, vice president of sponsor and tech strategy at Advarra, discusses her outlook for this year’s edition of the SCOPE summit. The global market for clinical trials is expected to grow to over $106bn by 2032, but stakeholders in this industry face increasingly challenging obstacles, including regulatory hurdles, talent shortages and clinical studies becoming…

WCG’s outlook for SCOPE 2025

As pharmaceutical pipelines and R&D investments expand worldwide, the global market for clinical trials is projected to grow by almost 9% per year from $48.2 billion in 2023 to $73.2 billion in 2028, partly driven by soaring demand for outsourced trial providers. However, clinical trial providers are facing challenges in completing trials efficiently, including long…

Patient Perspectives and Multidimensional Assessments

The evolution of clinical trials is being driven by an increased focus on patient perspectives and innovative statistical methodologies. Regulatory agencies are pushing for trials that better integrate patient needs, fostering more effective and inclusive treatments. Companies like One2Treat are leveraging this momentum, using advanced tools and expertise to streamline trial design and ensure real-world…

Johnson & Johnson acquires Intra-Cellular Therapies in $14.6bn deal

Johnson & Johnson has entered an acquisition agreement with drug developer Intra-Cellular Therapies priced at $14.6bn, positioning the deal as one of the largest seen in the pharmaceutical industry in the past year. Founded in 2002, Intra-Cellular Therapies develops innovative treatments for complex psychiatric and neurologic diseases, with a scientific platform based on the work…

Scope Summit 2025 award finalists announced

As the Cambridge Healthtech Institute (CHI) celebrates its 16th annual Clinical Ops Executives (SCOPE) Summit in Orlando, Florida, USA, next month, two awards, one for site innovation and another for patient engagement, have released their shortlisted finalists who will battle it out for the winner and runner-up positions. Recognizing Site Innovation in Clinical Trials For…

Anthem Biosciences plans IPO worth $397m

As India’s contract manufacturing and development organization (CDMO) is set to double in the next decade, Anthem Biosciences is planning to raise 33.95 billion rupees ($397m) in an initial public offering (IPO). Anthem expects to list its shares on the BSE (formerly the Bombay Stock Exchange) and National Stock Exchange of India, according to a…

Verdiva Bio’s launch is backed by financing of over $410m

The company’s launch is backed by an oversubscribed Series A round of $411m co-led by Forbion and General Atlantic. RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures and LYFE Capital also participated. Verdiva intends to pioneer next-generation oral and injectable treatments for obesity and other cardiometabolic disorders with first-in-class or best-in-class potential. A particular…

Denali’s ALS Drug DNL343 Misses Key Trial Endpoint

Denali Therapeutics has announced topline results from the phase 2/3 Healey ALS Platform Trial, which evaluated the effects of its drug candidate DNL343. The study did not meet the primary efficacy endpoint of slowing disease progression in comparison with a placebo, as measured using the ALS Functional Rating Scale-Revised (ALSFRS-R). What is ALS? Amyotrophic lateral…

Orbis Medicines bags €90 million Series A

Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, the assets and wealth manager of the Novo Nordisk Foundation. The company is developing treatments based on a class of drug called macrocycles – compounds with a ring-like structure. While macrocycles have yielded blockbuster drugs such as the fungal-derived immunosuppressive drug cyclosporine,…

Bremelanotide: Promising Diabetic Nephropathy Treatment

Palatin Technologies has announced topline results for the phase 2b Breakout study, which evaluated the effects of bremelanotide in patients with type 2 diabetic nephropathy. This condition is a severe complication of diabetes and the leading cause of renal failure in end-stage renal disease, however, there is currently no treatment that can achieve a complete…

Gilead taps into Terray’s AI-based drug discovery

According to the terms of the deal, Gilead will select a set of drug targets and Terray will discover and develop small molecule drugs that bind to them. Gilead has the option to exclusively license compounds in the deal and take on their development and commercialization. In return, Terray will receive an undisclosed upfront payment…

Brazil’s Nintx bags $10m for plant-based drugs

Founded by a team of scientists and healthcare specialists in 2021, Nintx harnesses compounds from Brazil’s world-famous plant ecosystems to develop treatments for complex, multifactorial diseases such as metabolic, immunological, cancer, and brain disorders. The startup unearths disease targets via data-focused technologies that simulate the gastrointestinal system and map out networks of proteins, the human…

AbbVie acquires Nimble for oral peptides

AbbVie and Nimble Therapeutics have announced an acquisition deal in which AbbVie will gain ownership of the company’s pipeline of oral peptide candidates. As part of the $200 million agreement, AbbVie will also acquire Nimble’s proprietary technology platform for peptide synthesis, screening, and optimization. Nimble Therapeutics was founded in 2019 as a spinout of Roche,…

General Inception acquires Enable Medicine

The company creator General Inception (GI) has acquired Enable Medicine to pool its know-how regarding drug development and the biotech ecosystem with the latter’s biological data offerings. A lot of biological data is fragmented and siloed away, making it difficult to harness for discovering new classes of drugs. To tackle this issue, Enable is building…

Noema Pharma Secures $147M to Advance CNS Disorder Treatments

Noema Pharma has announced an extension of its series B financing round, bringing the total raised up to $147 million (CHF 130 million). The round extension has seen venture capital firm EQT Life Sciences join the Swiss company’s existing investors, which include Forbion, Jeito Capital, Sofinnova Partners, and Gilde Healthcare among others. The funds will…

Eli Lilly expansion set to add 750 skilled jobs to Wisconsin site

Shortly after acquiring a manufacturing site in Wisconsin, Eli Lilly intends to expand it to boost its production of injectable products, including diabetes and obesity drugs Mounjaro and Zepbound. Eli Lilly has announced a $3bn expansion of its manufacturing facility in Kenosha County, Wisconsin, in the context of the growing demand for its diabetes and…

AbbVie set to file for FDA approval on tavapadon

Pharma company, AbbVie, reports that its D1/D5 partial agonist, tavapadon, has met the primary and secondary endpoints in a pivotal Phase 3 trial. The trial, called TEMPO-2, evaluated the investigational drug as a flexible-dose monotherapy for individuals with early Parkinson’s disease. Tavapadon is the first partial agonist of the dopamine receptors D1/D5, helping to activate…

PTC Therapeutics boosted by Novartis rights deal for Huntington’s program

PTC Therapeutics announced this week that it has made a deal with Novartis for global rights to its oral Huntington’s disease candidate PTC518, a splicing modifier of the huntingtin protein HTT. The drug is designed to cross the blood–brain barrier and lower levels of the mutant HTT protein, which developers hope will significantly improve outcomes…

Investment in radiopharmaceuticals is ramping up

Investment in radiopharmaceuticals is ramping up as big pharma shows a growing appetite for this promising drug modality. Radiopharmaceuticals see radioactive isotopes being delivered into a target, typically a cancer cell, to kill it. While they have existed for decades, interest in this drug modality was originally limited due to the elevated risk of side…

Mitsubishi and Dewpoint team up to tackle ALS

The pharma arm of Mitsubishi Chemical Group has launched a collaboration with US-based Dewpoint Therapeutics to co-develop a preclinical-stage treatment for the neurological condition amyotrophic lateral sclerosis (ALS). As part of the deal, Dewpoint can expect an undisclosed upfront payment from Mitsubishi Tanabe Pharma Corporation (MTPC) in addition to undisclosed “near-term” developmental milestone payments, with…

Körber absorbs Bähren to expand pharma packaging

The pharmaceutical business unit of the German giant Körber has snapped up the compatriot label and leaflet supplier Wilhelm Bähren GmbH & Co as the pharmaceutical packaging market is set to double in the coming decade. Körber’s pharmaceutical segment offers products to store and transport drug products, including folding boxes, sustainable packaging and secure boxes…

Novocure’s TTFields therapy boosts survival in pancreatic cancer

Swiss oncology specialist Novocure has announced positive topline results from the PANOVA-3 phase 3 clinical trial, which evaluated the use of tumor treating fields (TTFields) therapy in combination with the chemotherapy drugs gemcitabine and nab-paclitaxel. The trial met its primary endpoint of a significant improvement in median overall survival in patients with unresectable, locally advanced…

Tech-driven solutions for patient access

While these sites are important for clinical research, they make patient recruitment challenging. Many participants are forced to travel to these locations for recurring visits, and many face obstacles, such as taking time off work, childcare, or living in remote locations. With the rise of technology (and AI), decentralized clinical trials are becoming more popular…

Overcoming nonspecific binding challenges in PK assays

However, nonspecific binding (NSB) can hinder PK assays, impacting their accuracy and reliability. Fortunately, there are strategies and best practices to counter this issue. NSB occurs when analytes in a solution bind to a solid surface. This can happen at various stages of PK assays and can potentially skew results by affecting a formula’s dosage…

Diabetes prevention – Eli Lilly’s Tirzepatide shows 23% weight loss

Eli Lilly has released detailed results from the SURMOUNT-1 phase 3 trial, where over 1,000 obese or overweight prediabetic participants were followed over the course of 176 weeks, making it the longest study to date of tirzepatide. The data shows that weekly injections of tirzepatide significantly reduced the risk of progression from pre-diabetes to type…

AstraZeneca invests $3.5BN to boost US manufacturing power

With around $2 billion of the investment dedicated to creating more than a thousand U.S. jobs, AstraZeneca is looking to expand R&D and manufacturing facilities in states including Massachusetts, Maryland, and Texas dedicated to specialty manufacturing, biologics and cell therapies. The £158.7 billion ($200.8 billion) market-cap player is among the top ten biggest pharmaceutical companies…

Phase 3 success for AstraZeneca prostate drug

AstraZeneca has reported positive results from the CAPItello-281 phase 3 trial, which evaluated Truqap (capivasertib) in combination with Johnson & Johnson’s Zytiga (abiraterone) and androgen deprivation therapy (ADT) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). The combination therapy showed significant improvements on its primary endpoint of radiographic progression-free survival (rPFS) of…

FDA grants orphan drug designation to CervoMed’s dementia drug

The US company CervoMed announced yesterday that the FDA has granted Orphan Drug Designation to its oral investigational small molecule drug, Neflamapimod, for the treatment of frontotemporal dementia. The FDA’s decision is on based promising results from the company’s Phase 1 and 2 studies. Frontotemporal dementia is a rare neurological condition affecting approximately 50,000 to…

Portugal’s Hovione builds spray drying capacity in US and Ireland

Spray drying involves converting pharmaceutical liquid solutions into tiny droplets that are rapidly dried with hot gases such as nitrogen. This turns medicinal products into fine powders that can be easier to take as inhalable or oral formulations, especially for compounds that are hard to dissolve in water. Hovione’s latest investment, whose value is undisclosed,…

Adragos Pharma snaps up Baccinex to expand CDMO network

Founded in Munich in 2020, Adragos’ global manufacturing sites were acquired from other players including Haupt Pharma Livron, LAW Pharma, Sanofi and Fresenius Kabi. They offer a range of services including drug development, manufacturing, and supply chain management. The acquisition of Baccinex, which specializes in clinical trial supplies and smaller-scale commercial production, is designed to…

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Decentralized clinical trials market expected to grow to $25BN

According to a recent report by Business Research Insights, the total size of the global decentralized clinical trials market was $7.14 billion in 2023, a figure that is projected to grow to $8.19 billion by the end of 2024. The report forecasts that the decentralized clinical trials market will continue growing to reach $24.97 billion…

Equity boost and partnership aim to accelerate GEMS platform’s efficiency

NVentures also participated in the company’s $200 million Series B last August. This strengthened collaboration is aimed at advancing Genesis’ capabilities to tackle complex and previously undruggable disease targets through optimized AI technologies.The collaboration centers on advancing Genesis’ computational efficiency, with NVIDIA bringing specialized expertise to enhance the GEMS platform’s neural network performance, particularly in…

How eCOA/ePRO is transforming clinical trials

eCOA and ePRO (electronic patient-reported outcome) technology are transforming clinical trials, offering streamlined processes for patients, sites, and sponsors. In this Q&A, Steve shares how user-centric design, emerging trends, and collaboration are shaping the future of clinical research. The clinical trial landscape continues to evolve rapidly, and eCOA and ePRO are at the forefront of…

C Ray Therapeutics $100M to improve RDC technology platform

C Ray Therapeutics has announced the completion of a series A+ financing round, which has exceeded the $100 million mark. The round was co-led by Shenzhen Capital Group and TaiLong Capital, with participation of GL Ventures, 3SBio, Guanghua Wuting among others. Headquartered in Chengdu, China, C Ray Therapeutics specializes in the development of radionuclide drug…

Promising phase 2 results for Eli Lilly’s Muvalaplin

Yesterday, Eli Lilly and Company revealed promising Phase 2 results for its investigational small molecule drug, Muvalaplin, against cardiovascular events. The drug met its primary and secondary endpoints at 12 weeks, revealing a reduction of lipoprotein(a)– Lp(a)– levels by up to 85% in adults with high risk for cardiovascular events. Muvalaplin selectively inhibits Lp(a), a…

Chemistry passion to industry leadership

Now the Global market development manager at Phenomenex, she thrives on connecting insights with solutions, all while channeling the wisdom of her science-loving microbiologist father. Tran’s story is a testament to curiosity, perseverance, and finding unexpected paths beyond the lab. Could you give us an overview of your work? I serve as the biopharma market…

From lab to leading biopharma innovation

Now leading the Biopharma product management team at Phenomenex, she brings a problem-solving mindset honed by a love of forensic science and analytical chemistry. Her story showcases the power of patience, adaptability, and breaking traditional career molds to find success in a fast-paced, global industry. Could you give us an overview of your work? I…

Samsung Biologics and European pharma company enter major manufacturing deal

The global contract development and manufacturing organization (CDMO), Samsung Biologics, announced this week that it has entered into a collaboration with an undisclosed European pharmaceutical company, signing a series of manufacturing deals worth over $668 million. The company will provide manufacturing services through December 2031. “We are delighted to expand our partnership with the European…

Pfizer’s HYMPAVZI wins EU approval for hemophilia A and B care

The US big pharma company Pfizer has been granted marketing authorization for its hemophilia A and B treatment, HYMPAVZI (marstacimab), by the European Commission based on positive Phase 3 study results. In the EU, the drug is the first once-weekly, subcutaneous treatment for people with severe hemophilia B, and the first that can be administered…

Drug-free pain relief for knee osteoarthritis

Sameer Sabir, CEO and Co-Founder of Brixton Biosciences (Brixton Biosciences) Sameer Sabir, CEO and co-founder of Brixton Biosciences, is on a mission to revolutionize pain management. With Neural Ice, the company’s groundbreaking drug-free therapy, Brixton aims to offer ultra-long-lasting pain relief with a simple injection. Targeting knee osteoarthritis as its first focus, this novel technology…

Icotrokinra ‘best in class oral therapeutic for plaque psoriasis’

The phase 3 ICONIC-LEAD study showed that icotrokinra, a peptide drug that blocks the interleukin (IL)-23 receptor, was able to induce significant clearance of psoriatic plaques. The drug is being developed in conjunction with Johnson & Johnson and Protagonist will earn $115 million as a milestone payment from the big pharma for successful completing a…

Icotrokinra ‘best in class oral therapeutic for plaque psoriasis’

Pfizer’s HYMPAVZI wins EU approval for hemophilia A and B care

C Ray Therapeutics $100M to improve RDC technology platform

Promising phase 2 results for Eli Lilly’s Muvalaplin

Coronado’s CSO champions data-driven innovation in clinical trials

At the helm of Coronado’s scientific strategy, Professor Visser-Rogers envisions a data-driven future powered by innovative methodologies and emerging technologies. Her approach emphasizes not only precision medicine and patient-centric clinical trials but also the critical integration of AI, advanced analytics, and adaptive regulatory frameworks to meet the industry’s pressing challenges. Vision for Coronado Research: As…

Gifthealth partners with United Digestive

Gifthealth has announced a strategic partnership with United Digestive, a leading practice management organization for gastroenterology. This is to enhance patient access and improve preparation processes for gastrointestinal procedures. As a result of this collaboration, Gifthealth becomes the exclusive patient adherence and education platform for United Digestive, marking a significant expansion for the company, which…

Patients prefer telehealth for clinical trials, survey shows

Conducted with 136 US-based participants across multiple health conditions, the survey found that 63% said they would be more likely to join a trial if telehealth options were available. The company suggests this shift could help address logistical challenges, making participation possible without the need for extensive travel or in-person visits. The option to use…

AI-driven Medable Studio speeds digital trial startups

Medable, a provider of clinical development technology, has announced a collaboration with Google Cloud to bring its decentralized clinical trial platform to Google Cloud Marketplace, a digital store for third-party software solutions. This partnership will allow customers to benefit from cutting-edge technology of Google’s cloud infrastructure and artificial intelligence (AI) capabilities. “This alliance provides life…

Overcoming nonspecific binding challenges in PK assays

Diabetes prevention – Eli Lilly’s Tirzepatide shows 23% weight loss

Equity boost and partnership aim to accelerate GEMS platform’s efficiency

This forms part of an expanded partnership to enhance Genesis’ AI-powered drug discovery platform, GEMS (Genesis Exploration of Molecular Space). The new investment follows NVentures’ participation in Genesis’ $200 million Series B funding in August 2023. This strengthened collaboration is aimed at advancing Genesis’ capabilities to tackle complex and previously undruggable disease targets through optimized…

AstraZeneca invests $3.5BN to boost US manufacturing power

Decentralized clinical trials market expected to grow to $25BN

Tech-driven solutions for patient access

GHO and Ampersand acquire CDMO Avid Bioservices for $1.1 billion

Under the terms of the merger agreement, Avid Bioservices will be acquired by funds managed by GHO and Ampersand in a transaction valued at $1.1 billion. The acquisition price represents nearly a 22% premium to the company’s average share price for the past 20 days, and over six times the revenues expected in 2025. Based…

Merck, Abbisko’s oral drug aces phase 3 for rare tumors

According to the topline results, a total of 54% of patients given the treatment saw their tumors shrink compared to just 3.2% in the placebo group, hitting the primary endpoint of the trial. TGCT is a rare condition mainly caused by an overexpression of the protein colony stimulating factor-1 receptor (CSF-1R), which drives the proliferation…

Dexter Tjoa on Tjoapack’s journey and future in packaging

CEO Dexter Tjoa shares insights on the company’s journey, from early barcoding breakthroughs to embracing advanced technologies for patient safety, sustainability, and global compliance. Discover Tjoapack’s pivotal role in transforming the packaging landscape. Outsourcing Pharma’s senior editor, Liza Laws (LL) caught up with him to find out more. LL: Tjoapack recently marked 35 years in…

Axonis raises $115 million to treat epilepsy

Epilepsy is one of the most common neurological conditions in the world, with around 50 million people with the condition. There are a variety of approved medications for epilepsy and pain. but many patients cannot benefit from the drugs or have severe side effects such as depressive mood, psychosis and anxiety, according to Axonis’ website.…

Abzena unveils cell Line and ADC innovations at CPHI 2024

By offering comprehensive, integrated solutions, Abzena aims to streamline drug development processes and minimize risks for customers, helping to accelerate timelines and enhance production. OSP had a catch-up with them after the event to find out how things went. What new products or innovations did your company showcase at CPHI Milan 2024 this year? At…

Middle School MD fosters youth interest in medical careers

The Palomar Health Foundation recently completed its third annual Middle School Medical Discoveries (Middle School MD) program, engaging local youth in immersive learning sessions aimed at inspiring future healthcare careers. By directly connecting students with healthcare professionals, Middle School MD aims to nurture an early interest in medicine and highlight the crucial role healthcare professionals…

Novo Nordisk signs $285 million deal for a once-monthly Wegovy

Ascendis Pharma has granted Novo Nordisk an exclusive worldwide license to its TransCon technology platform for the development, manufacturing and commercialization of Novo’s products in metabolic diseases, including obesity and type 2 diabetes. The deal also covers an exclusive license in cardiovascular diseases granted on a product-by-product basis. As part of the licensing deal, Ascendis…

Senhwa Biosciences starts trial of drug for rare cancers in children

Silmitasertib, also known as CX-4945, was originally developed by Cylene Pharmaceuticals, a San Diego-based biotech that ceased operations in 2013. Since then, Senhwa Biosciences, which is headquartered in Taiwan but also has a San Diego base gained the rights to the small molecule, first in class, casein kinase 2 (CK2) inhibitor. CK2 is overexpressed in…

Veeva’s Tim Davis on overcoming eCOA deployment challenges

Tim Davis, vice president of strategy at Veeva eCOA, had a conversation with Outsourcing Pharma’s senior editor, Liza Laws, and sheds light on how the landscape is changing and what this means for study teams, sites, and overall trial efficiency. In this interview, Davis discusses the hurdles of eCOA, innovative solutions streamlining implementation, and the…

MD Anderson investment supports groundbreaking cancer therapies

Starget Pharma, an Israeli startup developing AI-powered precision therapies for difficult-to-treat cancers, has secured a $5.1 million investment from MD Anderson Cancer Center’s Cancer Focus fund. This latest funding round supports the clinical development of Starget’s unique radioligand-based therapies, designed to deliver targeted radiotherapy directly to tumor cells while sparing healthy tissue. Expected to revolutionize…

Novo Nordisk study – semaglutide reduces hospital admissions

Novo Nordisk has released data from the SELECT phase 3 trial showing that a 2.4 mg dose of semaglutide reduced the number of hospital admissions as well as the overall length of hospital stay for adults with obesity or overweight with previously established cardiovascular disease and without diabetes. Semaglutide is the active compound in Wegovy…

First-line leukemia therapy granted accelerated approval by FDA

Novartis’ Scemblix (asciminib) has received accelerated approval by the US FDA as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive myeloid leukemia in chronic phase (Ph+ CML-CP). The approval of Scemblix is based on results from the ASC4FIRST phase 3 trial, in which Novartis’ drug was compared to all other standard of care…

AI-driven outreach boosts therapy start, adherence rates

A new case study from AllazoHealth demonstrates that a top 10 rare disease pharmaceutical company experienced a 10.4% increase in therapy initiation through AI-driven patient outreach and tailored, multi-channel communications. The study highlights how AllazoHealth’s AI-enabled personalization strategy allowed the company to precisely time and tailor messages to patients, caregivers, infusion centers, and prescribers across…

Labguru ELN integration enhances Thermo Fisher LIMS capabilities

This integration aims to create a unified lab management experience, offering scientists enhanced data traceability, security, and streamlined workflows across a wide range of laboratory settings—from research and development to GXP-compliant environments. We spoke with Dino Kazanis, product manager, and James Swartz, commercial lead for the Labguru integration at Thermo Fisher Scientific, to learn more…

Vicky Marriott on leading with empathy in science and statistics

In an exclusive interview, Vicky shares insights on her career, the challenges she faced, and her passion for inspiring the next generation of women in science. Facing challenges head on, problem solving, and determination led her to become head of statistics at Phastar. She shares how statistics helped her see the real-life applications of mathematics…

Enhancing pharma manufacturing with digital twin technology

From reducing operational costs to enhancing patient outcomes, Stevanato Group is at the forefront of digital transformation in pharma. Digital Twin Technology: How has the implementation of digital twin technology at Stevanato Group enhanced your manufacturing processes? Can you share specific examples of how it has reduced risks and costs? Data management and AI are…

GLP-1 market heats up as companies vie for next-gen obesity drugs

Since the FDA approval of Novo Nordisk’s Wegovy as a treatment for chronic weight management in 2021, followed by the approval of Ozempic the next year, demand for GLP-1 agonist drugs has rapidly grown. So much so that both Novo Nordisk and Eli Lilly, which has two GLP-1 competitors, Mounjaro and Zepbound, have been facing…

Axonis raises $115 million to treat epilepsy

Anu Codaty’s path to biotech leadership

With a background spanning biotech and executive roles at Medtronic, Anu brings a unique blend of resilience, collaboration, and strategic insight to her role—transforming challenges into opportunities for growth in a traditionally male-dominated field. Could you give us an overview of your work? I am on the leadership team of Aldevron, a leading provider of…

NovAliX and Bruker forge alliance to boost drug discovery

This alliance marks a shift in biopharma R&D, with the launch of the Biophysics Institute for Biomedical Research (IBRB), offering top-tier scientific instrumentation and collaborative research support. Bruker’s minority stake in NovAliX, coupled with the collaboration’s focus on advanced analytical tools and biophysical expertise, positions the two companies to reshape the research landscape, particularly in…

Rentschler Biopharma to boost production with new buffer media station

Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) will be increasing its production at its headquarters in Laupheim with the construction of a state-of-the-art buffer media station. The new four-story facility is slated to open by the end of 2027 and be fully operational by 2028. “The new buffer media facility at our…

GSK beefs up US manufacturing with $800 million

GSK is one of the world’s biggest pharmaceutical companies with products ranging from the shingles vaccine Shingrix and the HIV antiretroviral medicine Dovato to general medicines such as the inhaled asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy. The latest investment is GSK’s biggest in the U.S. to date, with the aim of boosting…

Merck acquires Modifi Biosciences in $1.3B cancer drug deal

Modifi Biosciences, a spin out of Yale University founded in 2021, has been snapped up by Merck for $30 million paid upfront, and up to $1.3 billion in potential milestone payments. Modifi focuses on the development of small molecule drugs that target cancer cells with impaired DNA repair. “In founding Modifi Biosciences, we sought to…

NorthStar launches radiopharmaceutical CDMO

Radiopharmaceuticals consist of radioactive isotopes that are chemically attached to small molecules, peptides or protein drugs such as antibodies. These treatments are rapidly gaining traction in the treatment of cancer for their ability to zap tumors with deadly targeted radiation, and they depend on the scalable production of medical isotopes including Copper-67 (Cu-67) and Actinium-255…

Merck acquires Modifi Biosciences in $1.3B cancer drug deal

NorthStar launches radiopharmaceutical CDMO

Boston biotech secures funds to advance depression, anxiety drug

Seaport has developed a platform called Glyph designed to enhance efficacy and reduce the side effects of potential drug candidates. The original research behind the platform came from Monash University in Australia. Potential medications developed using Glyph are absorbed like fats in the diet through the lymphatic system. The Series B adds to Seaport’s $100…

Donanemab Alzheimer’s drug approved by MHRA, rejected by NICE

A new Alzheimer’s treatment, donanemab, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but a draft decision by the National Institute for Health and Care Excellence (NICE) has rejected the drug for use on the NHS. Manufactured by Eli Lilly, donanemab, also known as Kisunla, is designed to slow cognitive decline…

PTC Therapeutics DMD drug misses regulatory hurdle

The EU first gave Translarna a conditional marketing authorization in 2014 for the treatment of DMD, a progressive condition that causes the muscles to weaken, eventually becoming life-threatening. Eligible patients for the treatment are at least 2 years old, are able to walk, and their disease is caused by a so-called nonsense mutation in the…

PTC Therapeutics DMD drug misses regulatory hurdle

Acquisition adds late-stage drug candidate with blockbuster potential

Lundbeck and Longboard Pharmaceuticals have announced an agreement for the Danish pharmaceutical company to acquire all outstanding shares of Longboard, in a transaction valued at $2.6 billion in equity value. The transaction is expected to close by the end of the year. The deal will give Lundbeck ownership over Longboard’s pipeline of drug candidates for…

The industry is opening up to techbio – panel highlights

Techbio is a field where the computational expertise of the tech sector and the biological know-how of the biotech sector converge. This leads to applications including the use of clinical and genomic data as well as sophisticated artificial intelligence (AI) algorithms to cut healthcare costs, deliver personalized medicine, and speed up drug discovery. “If you’re…

Women in Science – SCIEX Rebekah Sayers

Find out all about her intriguing journey to where she is now in her role as marketing manager within small molecule omics at SCIEX. Could you give us an overview of your work? One of the things I love about my job is the fast paced and dynamic environment, every day is different and brings…

Jane Koo’s role in advancing cancer therapies at CTMC

With a career spanning monoclonal antibodies and now cell therapies, she expertly navigates complex regulatory landscapes to bring life-changing treatments to patients. Her passion for science, leadership in regulatory strategy, and commitment to advancing cancer cures drive her work every day. Could you give us an overview of your work? CTMC is a unique therapeutics…

Corden Phama – staying on top of manufacturing trends

Outsourcing Pharma caught up with experts from the global CDMO, CordenPharma, to learn how they maintain their competitive edge. Brittany Hayes, Global Platform Director for Highly Potent & Oncology, and Ilia Freifeld, Global Platform Director for Small Molecules at CordenPharma, shared their insights with Outsourcing Pharma at CPHI. How would you describe the current global…

Sanofi halts Denali’s MS drug trial after phase 2 failure

The K2 trial tested oditrasertib’s safety and ability to reduce the blood levels of neurofilament light chain, a biomarker of neuronal damage in multiple sclerosis. However, the trial failed to meet its primary and undisclosed key secondary endpoints, according to a filing. Multiple sclerosis is a degenerative and progressive disorder where the immune system attacks…

Precision dosing expert Sharmeen Roy

With a background in pharmacy and specialized pediatric care, she now bridges bioinformatics with practical, user-friendly tools, empowering clinicians to make patient-specific dosing decisions. Her passion lies in improving patient safety by reducing medication-related errors and driving innovations that directly impact healthcare outcomes. Could you give us an overview of your work? At DoseMe, our…

From researcher to market leader at SCIEX

Now a global market development manager, she plays a pivotal role in shaping solutions for food safety and environmental protection. In this Q&A, Gitte opens up about her inspiring journey, the hurdles she’s overcome as a woman in STEM, and the lessons she’s learned along the way. Could you give us an overview of your…

Enzene targets cost savings and efficiency

The significant advantages it offers include: Large reduction in COGS: By 2025, EnzeneX 2.0 expects to produce 40 kg/1000 L batches at $40/gram, redefining FCCM economics. Lower operational costs and higher productivity can lead to up to 50% reductions in overall cost per gram. Higher Titer Clones: EnzeneX 2.0 maximizes protein yield per cell line…

SGD Pharma to showcase new glass packaging solutions at CPHI 2024

These siliconized vials are designed to protect sensitive, aggressive, and viscous drug products by reducing interactions with the glass and preserving the integrity of the contents. Available in both clear and amber glass, and in sizes ranging from 3ml to 500ml, these vials are suitable for various drug delivery methods, including parenteral, oral, and nasal…

Third-generation lung cancer therapy commercialized

Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (Ask Pharm) have announced a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) intended for the treatment of lung cancer. Under the terms of the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China and will receive a…

Evaxion AI platform identifies cancer vaccine targets in trials

Danish techbio company Evaxion Biotech has published results showing the outcome of three clinical trials comparing the prediction scores of its AI-Immunology platform with patients’ immunological responses. The AI-immunology platform can identify targets – called neoantigens – for cancer vaccines and predicts the specific immune response of a particular vaccine target against a tumor. In…

AstraZeneca strikes $2 billion deal with CSPC

Dyslipidemia, a condition involving unhealthy levels of cholesterols and other fats in the blood, is a major risk factor in cardiovascular diseases, which make up the world’s biggest killer with 17.9 million deaths per year. While there are treatments for dyslipidemia, they are not sufficient to control the blood levels of low-density lipoprotein cholesterol, or…

FDA clearance to start clinical trials with new obesity drug

Antag Therapeutics has announced that the FDA has accepted the investigational new drug (IND) application for its lead drug candidate, AT-7687. This will enable Antag Therapeutics to initiate a phase 1 clinical trial to evaluate the small molecule drug candidate in both healthy lean and healthy obese individuals. The study will also explore the combination…

Recipharm bolsters global production facilities

One of Recipharm’s main aims is the expansion of its oral solid dosage and sterile fill & finish services in sites in Europe, the U.S., Israel and India, with the aim to cover all phases of drug development from active pharmaceutical ingredient synthesis to commercial manufacturing. Recipharm began its life in 1995 as Recip and…

How will the Biosecure Act impact the pharma industry?

But what does the Act mean for the biotech and pharma industry and how can companies best prepare for any impacts on future business? The Biosecure Act was first proposed by the US government late last year due to concerns about national security and how genetic and other biological data could be misused by foreign…

Will AI live up to its promise and how will it impact global health?

One area it is thriving is pharmaceuticals as it is being used to bring drugs to market faster than ever before. OSP sat down with Melanie Nelson, director of product management, solutions and integrations at Dotmatics, a research and development (R&D) scientific software company to find out where they think AI will take the industry and…

Will the Biosecure Act impact the pharma industry?

Big reveals for dsm-firmenich at CPHI 2024

Located at booth 3B25 (API Hall 3), the company says it will demonstrate its ongoing commitment to advancing the global pharma market. The company aims to continue elevating therapy development – and at this year’s CPHI it will be showcasing its first-to-market CBtru drug product intermediate and taste modulation solutions for enhanced therapy convenience and…

Adragos Pharma and the evolving world of outsourcing

We also delve into the latest trends, the rise of AI and the increasing focus on sustainability. How has the role of contract development and manufacturing organizations (CDMOs) evolved over the last five years? The role of CDMOs has shifted significantly since the onset of the COVID-19 pandemic, with the pharma industry now focusing on…

FDA compliance and AI drive growth for Quotient

He will also be explaining how the company is expanding its Translational Pharmaceutics platform into new therapeutic areas like mRNA, and using AI to optimize drug development. With a focus on compliance, innovation, and streamlining processes, he says the company continues to set itself apart in the pharmaceutical industry. We caught up with him before the…

Symbiosis unveils expanded facility at CPHI Milan 2024

The event provides a great platform for the company to present its newest addition—a 20,000 sq ft facility in Stirling, UK, which the company says enhances Symbiosis’ ability to support biopharma companies with high-quality manufacturing solutions. Colin MacKay, founder and CEO of Symbiosis, shared exclusive insights in a recent interview with Outsourcing Pharma. Symbiosis has long…

Ardena expands bioanalytical and GMP services

The company explains attendees will gain insight into how Ardena’s innovations can streamline drug development for advanced therapies, particularly in oncology and specialized therapeutic areas. OSP spoke to Jeremie Trochu, CEO at Ardena in the build-up to the show. What new products or innovations is your company showcasing at CPHI Milan this year? Ardena will spotlight…

Stevanato to launch Vertiva 10mL on-body system at CPHI 2024

The company says this new platform is specifically designed to administer large-volume injectable therapies, including highly viscous biological drugs, making it suitable for a wide range of conditions such as cardiovascular diseases, oncology, immunology, and pain management. It offers a pre-filled and pre-loaded on-body solution that can be customized to deliver drugs in different dosing…

Optimizing patient recruitment for faster clinical trials

The success of these trials hinges on finding and enrolling the right patients in a timely manner. Eben Scanlon, chief customer officer at OneStudyTeam, has spent over two decades working in clinical data management and recruitment strategy. In this interview, Scanlon shares insights on how biopharma companies can optimize patient recruitment by collaborating with specialized…

Women in Science – SCIEX Rebekah Sayers

SK pharmteco invests $260M in small molecules

The expansion involves setting up a new facility, which is planned to begin operations in late 2026. The facility, which will include 300 new hires, will have a footprint of 135,800 square feet with eight production trains with an output of tens of metric tons annually. After a difficult period with shocks from the Covid-19…

LoQus23 raises £35M to advance Huntington’s disease therapy

UK-based company LoQus23 Therapeutics has announced the closing of a £35 million series A round to advance its pipeline of small molecule drugs. The financing was led by Forbion and joined by existing investors Novartis Venture Fund (NVF) and SV Health Investors’ Dementia Discovery Fund (DDF). LoQus23 focuses on developing small molecule drugs that are…

Sequentia Biotech bags €10m for omics products

Sequentia will use the round winnings to speed up the market introduction of its cloud-based and microbiome-focused healthcare software MICK and scale up the development of its technology offerings. The round was led by Seventure Partners, a French venture capital firm with a history of backing microbiome-focused companies developing disease treatments including Microbiotica and MaaT…

The impact of AI technology in pharmacovigilance

Eric Prugh is the chief product officer at Authenticx, a US-based company that recently launched an AI solution to detect adverse events in conversations to empower pharmacovigilance. Prugh leads product strategy, design, and product marketing at Authenticx and has spent more than 15 years building and scaling software companies. In this Q&A with Outsourcing Pharma,…

From philosophy to biochemistry – Women in Science

With a passion for problem-solving and sustainability, her journey into science began with a fascination for philosophy and the origins of life, ultimately leading her to specialize in biochemistry. Read her full and fascinating story here: Could you give us an overview of your work?  As department lead, I am responsible for determining the overall…

Pfizer withdraws sickle cell drug over safety

The withdrawal decision was prompted by clinical data indicating that the overall benefit of Oxbryta “no longer outweighs the risk” in its target patient population, the company said in a public release. Specifically, the trials outline an “imbalance” in vaso-occlusive crises and fatal events that the company will assess further. The move to stop clinical…

AbbVie reports positive phase 3 results for Parkinson’s drug

The oral, specific dopamine agonist met its primary endpoint in the trial, which is the second of three phase 3 trials testing tavapadon for treatment of Parkinson’s disease. AbbVie acquired Cerevel Therapeutics earlier this year and tavapadon is the company’s lead candidate drug. Cerevel originally spun out from Pfizer in 2018 and has a neurology…

Biohaven’s troriluzole shows promise in spinocerebellar ataxia

Biohaven, which spun out of Biohaven Pharmaceuticals in 2022 when its parent company was acquired by Pfizer, has had a number of setbacks in the development of troriluzole –a prodrug of riluzole– including a phase 3 trial failure in 2022. However, the company continued development, as results of the failed phase 3 trial showed that…

Miplyffa bags FDA approval for ultra-rare disease

NPC is a progressive disease where the patient has a mutation in NPC1 or NPC2 – genes that are involved in the processing of cholesterol and other lipids inside cells. Cells with this mutation have a faulty management of lipids, leading to organ damage and neurological symptoms including difficulty with speech and cognition. Delivered as…

Nura Bio secures $140M to advance lead drug to next trials

Nura Bio has announced the addition of $68 million to its series A financing, closing the round with a total of $140 million. The investment was led by The Column Group and joined by Samsara Bio Capital, Euclidean Capital and Sanofi Ventures. Based in San Francisco, Nura Bio is a clinical-stage biopharmaceutical company that focuses…

Insilico’s lead drug meets safety and efficacy goals in IPF trial

Insilico Medicine, a biotech company with offices in both China and the US, announced this week that its lead candidate drug had met its primary endpoint of safety and its secondary efficacy endpoints. INS018_055 (also known as ISM001-055) is a small molecule drug candidate targeting TRAF2- and NCK-interacting kinase (TNIK). TNIK inhibitors are being investigated…

YPrime COO Alison O’Neill -‘pursue what you enjoy and be flexible’

She brings her global experience across multiple therapeutic areas to her current role leading operations at YPrime. In this position, Alison oversees project management and all teams responsible for the quality of project delivery – she ensures the excellence of services provided to sponsors, sites, and patients. Could you give us an overview of your…

CluePoints unveils expert speaker line-up for RBQMLive 2024

As the premier sponsor, CluePoints is helping to elevate RBQMLive as the industry’s leading event focused on the evolving field of risk-based quality management. Taking place virtually on September 24-25, 2024, RBQMLive is a free event designed for professionals involved in clinical trials who are keen to deepen their understanding of RBQM approaches. RBQMLive 2024…

F2G raises $100M to advance olorofim after FDA rejection

Infections caused by Aspergillus species of mold are transmitted through inhalation and can lead to symptoms including hypersensitivity reactions and tissue damage. Invasive aspergillosis (IA) is a particularly life-threatening infection that happens in high-risk immunosuppressed people. While these infections can be controlled with antifungals, increasing numbers of cases are becoming resistant to these drugs. At…

German pharma to submit FDA application after nerandomilast success

Boehringer Ingelheim reported this week that its phase 3 Fibroneer-IPF trial had met its primary endpoint of an improvement in Forced Vital Capacity (FVC), a measure of lung capacity, versus placebo. “This is the first idiopathic pulmonary fibrosis phase-3-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, Head of Global Therapeutic Areas…

uMotif acquires ClinOne, integrates eConsent for clinical trials

Announced on September 4, 2024, this acquisition positions uMotif to enhance its existing capabilities by integrating ClinOne’s enterprise consent management, site productivity tools, and trial awareness solutions into its modern electronic Clinical Outcome Assessments (eCOA) and electronic Patient-Reported Outcomes (ePRO) platform. This strategic move strengthens uMotif’s commitment to improving both the patient and site experience…

Women in Science – Vaxess CEO on owning your seat at the table

She is CEO of Vaxess and wants to be able to deliver therapeutics in the most patient-friendly and pain-free way. Read our interview with her to find about more about her fascinating journey and the obstacles she overcame. Could you give us an overview of your work? I’m the CEO of Vaxess, a life science…

EORTC extends Medidata partnership to advance data-driven cancer research

The four-year extension focuses heavily on enhancing data management in oncology research, allowing EORTC to streamline patient access to clinical trials and optimize trial participation while leveraging a single platform for comprehensive data handling. As clinical trials increasingly generate vast amounts of complex data, EORTC is now utilizing 13 Medidata solutions to manage all trial…

Slope unveils tech-enabled solutions to optimize clinical trial data

The company’s latest offering empowers clinical trial sponsors to harness the full potential of their biospecimen data, transforming it into actionable insights throughout the trial process, from startup to closeout. Mark Melton, Slope Mark Melton, vice president of biospecimen data and operations at Slope, emphasized the added value of these services: “Our sponsor customers of…

Envision Pharma Group unveils new data management platform

The company says this new data and analytics management solution marks a significant shift in how medical affairs professionals can access, manage, and optimize complex data. The launch of the new platform is a foundational moment for the company, harnessing the power of big data to enhance decision-making and improve patient outcomes. It is designed…

Optimize clinical trials with Phastar’s RBQM app & analytics

The tool supports critical RBQM processes like risk assessment, central monitoring, issue management, risk reassessment, targeted site monitoring, and KRI tracking, while ensuring regulatory compliance and enabling continuous, data-driven improvements throughout the clinical trial. What is the RBQM app? A clinical RBQM application typically offers a centralized dashboard where all the critical data from multiple…

ethics and AI in healthcare marketing

Leslie Pascaud, chief marketing officer at ObvioHealth, believes the key to effective marketing remains grounded in three fundamentals: a compelling product, addressing genuine customer needs, and a distinct brand position. Yet, in today’s AI-enabled world, these basics must be adapted to leverage the latest technologies responsibly. According to Pascaud, AI’s ability to personalize communication is…

AI and a growing confidence in transforming drug development

In this Q&A, Dr Fabrice Chartier (FC), CEO of Simbec-Orion and Joern Klinger (JK), CEO of biotx.ai explore AI-enabled causal modeling, its unique advantages and strategic implementation for clinical development. What is AI-enabled causal modelling and what is its main application? JK: Both machine learning (ML) and AI are based on statistical modelling and most statistical…

Remote dosing and culturally informed OUD solutions

The report, called ‘The strategic allocation of opioid settlement funds – an evidence-based approach to preventing deaths from opioid use disorder’ examines both the challenges and opportunities that come with this funding, drawing lessons from the past mismanagement of tobacco settlement funds. It also provides evidence-based recommendations for improving public health and advancing treatment innovation.…

The need for new clinical trial designs in cancer

Ravi Karra, VP of Oncology at the service provider Advanced Clinical, explains how advanced imaging techniques and trial designs can overcome the obstacles of taking a cancer drug to market. Clinical drug development is traditionally sequential, going from small phase 1 trials to assess safety all the way to large phase 3 trials and beyond…

Women in Science – Cytiva’s Emannuelle Cameau

Read our interview to discover how losing her beloved horse ended her desire to be a vet to her belief in destiny and transformative power of pursuing opportunities got her to where she is now. Could you give us an overview of your work? In my current role, I never get bored. It is hard…

AI-enabled platform by Creyon Bio receives second US Patent

This patent protects the company’s proprietary Creyon platform, which rapidly engineers and optimizes OBMs, marking a significant advancement in the field of precision medicine. The patent (No. 12,057,197) covers Creyon’s method for training machine-learned models to design oligonucleotides—short DNA or RNA molecules—based on specific pharmacological and biophysical properties. Unlike traditional trial-and-error approaches, Creyon’s platform significantly accelerates drug…

New report investigates pharma’s global reach and impact

A new report from the Access to Medicine Foundation takes a groundbreaking look at how some of the largest pharmaceutical companies are addressing patient access globally, particularly in low- and middle-income countries (LMICs). The report examines current efforts to measure and report patient reach, revealing both the progress made and the areas where more work…

Women in Science – Cytiva’s Beate Mueller

With a passion for science and an ‘eternal technology optimist’, she says playing a role in getting patients they need is humbling and motivating. Find out more about her journey in our interview. Could you give us an overview of your work? I am the chief technology officer for Cytiva. I am privileged to lead…

Seqster, PatientsLikeMe join forces to enhance clinical research

This collaboration, the healthcare technology companies say, promises to streamline clinical trial recruitment and optimize long-term patient engagement. “This partnership unlocks enormous value for patients, researchers, and healthcare companies by driving the last-mile data connectivity and accelerating clinical trials with real-time EHR data,” said Ardy Arianpour, CEO and co-founder of Seqster. “Our joint solution empowers…

LabWare and Mettler Toledo integrate software for lab efficiency

The connector seamlessly integrates LabWare’s Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) with Mettler Toledo’s LabX software, providing a streamlined solution for laboratories worldwide. The partnership between LabWare, a leader in laboratory information management systems, and Mettler Toledo, a global provider of precision instruments and software solutions, addresses the growing need for…

How SOMS is shaping the future of clinical trials

Kizewski delves into how SOMS is changing trial design, optimizing patient safety, and enhancing the chances of FDA approval, providing critical insights into the future of AI-driven clinical trial optimization. Impact of Sub-population Optimization & Modeling Solution (SOMS) How has SOMS transformed the landscape of clinical trials since its implementation? The Sub-population Optimization & Modeling…

Blood-based Alzheimer’s test set to revolutionize early diagnosis

The collaboration between ALZpath and Beckman Coulter marks a significant step toward making early detection more accessible and less invasive. The introduction of a blood-based diagnostic test, featuring ALZpath’s novel pTau217 antibody, could transform how Alzheimer’s is diagnosed and treated worldwide. In this Q&A, Chad Holland, president and CEO at ALZpath, and Frederic Jean, vice…

myTomorrows and Pancreatic Cancer Europe partner to aid patients

The partnership aims to enhance access to clinical trials for patients suffering from pancreatic cancer by leveraging myTomorrows’ extensive database of ongoing trials. Pancreatic cancer is notoriously challenging to treat, with a life expectancy of only 6-12 months at the time of diagnosis and a five-year survival rate of just 10%. The disease is difficult…

Unlocking drugs from microbial DNA: Empress Therapeutics’ mission

As head of platform development at Empress Therapeutics, Thompson uses her expertise to advance the company’s Chemilogics platform. This platform explores the vast universe of genetic chemistry, or metagenetics, within the human body, enabling the rapid and predictable generation of advanced starting points for small molecule drug candidates. Can you explain the concept of metagenomics…

Memorial Hermann expands life-changing cancer care partnership

This collaboration, which began in 2023, has significantly enhanced patient outcomes and healthcare efficiency through a hybrid model integrating digital, virtual, and in-home care for cancer patients. The partnership initially launched at Memorial Hermann-Texas Medical Center, the system’s flagship hospital, with the goal of providing cancer patients with continuous, personalized care. Patients enrolled in the…

2M vaccines ready to fight mpox

Mpox is a viral infection with symptoms including rash and fever, and spreads through contact with body fluids, skin lesions and contaminated materials such as clothes and needles. While the disease is considered endemic to countries central and west Africa, an outbreak went global in 2022 and was declared as a PHEIC until it declined…

Melanie Adams-Cioaba on leading the cryo-EM revolution in drug discovery

As the senior director and general manager of pharma (Cryo-EM), Melanie is not only pioneering the use of technology to accelerate the design of next-generation therapeutics but also championing diversity and inclusion in the scientific community. Her journey from a curious child in a science teacher’s lab to a leading figure in the life sciences…

DirectSens launches XpressGT for early diagnosis of critical conditions

The tool, aimed at research use only (RUO), promises to significantly improve early diagnostic capabilities in these areas. XpressGT: A new diagnostic frontier XpressGT measures levels of 2-hydroxybutyrate (2-HB) in venous blood, offering results in just eight minutes using standard clinical analyzers. Elevated 2-HB levels, a byproduct of liver function, are associated with various endocrine…

Nxera Pharma’s partnered schizophrenia candidate shows promise

Results from a phase 2 trial of the candidate schizophrenia drug, currently known as NBI-1117568, show that it met the primary trial endpoint of a significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score. The San Diego-based biotech Neurocrine Biosciences licensed the muscarinic M4 selective agonist from Nxera Pharma (then Sosei Heptares) as…

Nasal spray for anaphylactic shock approved in Europe

The company, focused on solutions for severe allergic reactions was granted the approval last week, on August 22. This marks a signifcant advancement in the treatment of severe allergies across Europe. Breakthrough approval for EURneffy marks a new era in allergy treatment It represents a significant advancement in the treatment of severe allergic reactions across…

Balversa Shows 36% reduced death risk in urothelial cancer

This approval marks the first pan-FGFR kinase inhibitor approved in the European Economic Area for this indication, providing a significant advancement for patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor. The approval is based on data from the phase 3 Thor study, which demonstrated a 36%…

Highlight 1 study to test fezolinetant in women with breast cancer

The first patient has been dosed, marking a significant step in addressing the needs of a patient population that currently lacks approved treatments for moderate to severe VMS. Breast cancer remains the most common cancer among women worldwide, with approximately 2.3 million new cases reported in 2022. Adjuvant endocrine therapy, which includes treatments like tamoxifen…

Blood-based Alzheimer’s test set to revolutionize early diagnosis

ENA Respiratory advances study of nasal powder

The ongoing study, conducted at the Scientia Clinical Research facility in Sydney, Australia, is focused on evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 when administered intranasally. The study plans to recruit up to 40 participants, with the goal of providing robust data that will inform further clinical development. The first two cohorts have…

Amgen’s Otezla approved for pediatric plaque psoriasis

This marks a significant milestone as Otezla is the first FDA-approved oral medication for children and adolescents in this category. The approval, granted earlier this year by the U.S. Food and Drug Administration (FDA), is a breakthrough for young patients who are candidates for phototherapy or systemic therapy and weigh at least 20 kg (44…

Amgen’s Otezla approved for pediatric plaque psoriasis

Melanie Adams-Cioaba on leading the cryo-EM revolution in drug discovery

H1 partners with GRM to deliver critical aid in Ukraine

This collaboration builds on the success of H1’s earlier efforts in the Middle East following the Hamas attacks on October 7th, where the company swiftly mobilized doctors to deliver essential medical care. The H1 Connect platform, developed as a direct response to these efforts, has since become a vital tool in linking healthcare professionals with…

H1 partners with GRM to deliver critical aid in Ukraine

Women in Science – uMotif’s chief marketing officer, Elaine Maynard

Her journey, shaped by early experiences with illness in her family, has fueled Elaine’s commitment to advancing patient-centric technologies. At uMotif, her focus remains on enhancing the patient experience, making clinical trials more compassionate, efficient, and ultimately more effective in delivering hope to those in need. Could you give us an overview of your work?…

Ayvakit drives 185% revenue surge in 2024 with strong global growth

This exceptional performance underscores the profound impact Ayvakit is having on patients with systemic mastocytosis (SM), a rare and debilitating disease. The therapy’s growth is driven by strong patient adherence, a growing prescriber base, and a successful global expansion strategy. As Blueprint Medicines continues to redefine treatment standards and expand its reach, Ayvakit is poised…

2M vaccines ready to fight mpox

Accelerated FDA approval for primary biliary cholangitis treatment

This approval is particularly significant for patients who have had an inadequate response to ursodeoxycholic acid (UDCA), the current standard of care, or for those who are unable to tolerate UDCA. With no cure currently available for PBC, the introduction of Livdelzi provides a critical new treatment option for this underserved patient population. Livdelzi’s approval…

Inside IQVIA’s innovative drug supply chain with Stefan Duerr

At the helm of innovation in this domain is Stefan Duerr, the senior director of product management and client delivery at IQVIA IRT and the Head of the Drug Supply Center of Excellence. With a rich background in molecular biology and an executive MBA, Stefan brings a blend of scientific rigor and business acumen to…

How Systech secures pharma supply chains from counterfeits

Through innovative platforms like UniSecure and UniTrace, Systech ensures unparalleled transparency, security, and compliance across global pharmaceutical supply chains. These solutions not only enhance the speed and accuracy of detecting counterfeit products but also enable real-time tracking and data integrity, making them essential tools for the industry. OSP spoke to Joseph Lipari, director of product. How…

nuVizz CEO on pharma supply chain solutions and innovation

The company also optimizes routes and ensures compliance with stringent industry regulations. Guru Rao, CEO of nuVizz, chats to OSP and provides insights into how the company’s solutions are making a significant impact on the healthcare and pharmaceutical industries. Revolutionizing healthcare logistics The nuVizz SaaS platform is designed to bring visibility, control, and cost savings to every…

Boosting pharma supply chains – Certa on compliance and transparency

With regulations like the Drug Supply Chain Security Act (DSCSA) in the United States and the European Union Medical Device Regulation (EU MDR) requiring stringent traceability, the need for robust technology solutions has never been greater. Jag Lamba, CEO and founder of Certa, discusses with OSP how the company’s platform is designed to help pharmaceutical…

TraceLink teams up with Tecsys

This collaboration seeks to address some of the most pressing challenges in healthcare, including compliance with the Drug Supply Chain Security Act (DSCSA), product recall management, and 340B program optimization. Shabbir Dahod, president and CEO of TraceLink, sheds light on the significance of this partnership and how it aligns with the broader goals of both…

Intelliguard and Cencora boost RFID medication compatibility

The collaboration is set to revolutionize the healthcare supply chain by increasing the compatibility between RFID (radio frequency identification)-tagged medications and RFID-based medication management systems. This partnership enables Intelliguard’s Mira Prep and Mira Care stations to read and decode Cencora’s RFID-enabled medications seamlessly. This integration allows healthcare providers access to a broader range of RFID-tagged…

Tonix Pharma offers hope to fibromyalgia sufferers

The news was shared at at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam. The company presented data demonstrating that TNX-102 SL significantly reduced pain and improved sleep quality in fibromyalgia patients, positioning it as a potential breakthrough in treating this debilitating condition. Fibromyalgia, recognized as a nociplastic…

Almac Diagnostic Services’ Katarina Wikstrom

She obtained a PhD in experimental pathology from Lund University, and subsequently completed a postdoctoral fellowship on the molecular mechanisms of prostanoid signaling in vascular haemostasis and oncology at University College Dublin. Could you give us an overview of your work? Almac Diagnostic Services supports Pharma and Biotech in the discovery, development and commercialization of…

Lonza expands manufacturing with bottling and labeling at US site

The upgrade includes the installation of advanced bottling and labeling equipment, aimed at enhancing early-phase clinical manufacturing services. This development is expected to accelerate the delivery of drug products to clinical trial centers, offering a substantial benefit to Lonza’s clients in the pharmaceutical and biotech industries. The new equipment is designed to handle solid dosage…

PLAIO secures €4.3M to expand AI pharma planning platform

The funds will be deployed to expand its operations across the US and Europe, with a particular focus on enhancing its AI Coplanner tool and forging strategic partnerships that will cement its status as a leader in the market. Its creative platform addresses a critical gap in the pharmaceutical industry, where over 95% of companies…

FDA approves needle-free epinephrine nasal spray for anaphylaxis

This marks the first significant innovation in epinephrine delivery in more than 35 years and offers an alternative to the anxiety-inducing needle injections that have long been the only emergency treatment available for anaphylaxis. What is Anaphylaxis? Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur within minutes of exposure to an allergen.…

Women in Science – uMotif’s chief marketing officer, Elaine Maynard

Expert insights on pharma outsourcing with CluePoints

To gain a deeper understanding of this complex landscape, OSP sat down with three industry experts from CluePoints: Francois Torche, Steve Young, and Patrick Hughes. They shared their perspectives on various facets of the industry, focusing on product development, regulatory frameworks, and the industry’s branding and landscape. Francois Torche (FT): Focusing on product development How…

Harnessing technology for a new era in drug development

PhaseV, under the leadership of CEO Raviv Pryluk, stands at the forefront of this transformation. In this interview, Pryluk shares his journey, insights, and innovative approaches that are revolutionizing clinical trials to enhance efficiency, effectiveness, and patient outcomes. Outsourcing Pharma (OSP): Could you start by giving us a bit of your background and how you…

FDA requests more trials for Lykos PTSD drug approval

The FDA has determined that the drug, aimed at treating PTSD, cannot be approved without further data and has requested an additional phase 3 trial to reassess its safety and efficacy. This decision comes after an FDA Advisory Committee meeting in June, where concerns were raised about the durability of midomafetamine’s effects and potential biases…

FDA poised to decide on Lykos’ MDMA therapy for PTSD

This decision follows a mixed response from the FDA advisory committee, which voted against recommending the treatment. However, the need for new PTSD treatments remains urgent, and some experts are optimistic about its potential impact. Currently, more than 13 million people in the US suffer from PTSD, including many veterans and victims of domestic and…

Optimizing medical equipment maintenance strategies

Patel delves into the intricacies of equipment lifespan, cost management, downtime impact, and the importance of predictive maintenance, offering practical advice for improving operational efficiency and patient care. As you know an ultrasound machine should be replaced every 5-7 years, and X-ray machines can last 10-14 years assuming 10,000-20,000 examinations are performed on them each…

Partnership’s founding of institute to foster therapeutic innovation

As part of this alliance, Bruker has acquired a minority stake in NovAliX, and says this highlights the increasing importance of CROs in the rapidly Stephan Jenn, president of NovAliX evolving pharmaceutical industry. The collaboration aims to harness the combined strengths of NovAliX’s expertise in structural biology, biophysics, and pharmacology with Bruker’s analytical technology. Together,…

What is precision psychiatry? Insights from Universal Brain

Outsourcing Pharma had the opportunity to speak with Kazu Okuda, MD, CEO, and co-founder of Universal Brain, about the advancements in precision psychiatry, the role of objective data, and the future of mental health treatment. What is precision psychiatry? Precision medicine is an emerging and significant focus in psychiatry. Unlike other medical specialties, psychiatry has…

Skye and Beacon collaborate on sleep apnea 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…

Red Queen launches to tackle viral infections

Backed by a $55 million Series A funding round from Apple Tree Partners (ATP) and a contract with the Biomedical Advanced Research and Development Authority (BARDA), Red Queen Therapeutics is set to advance its novel antiviral platform. The company’s technology recently achieved clinical validation in COVID-19 patients, highlighting its potential to address a wide range…