Bio Pharma Dive
DECEMBER 15, 2023
Welireg, which Merck got through its purchase of Peloton Therapeutics, can now be used to treat an advanced form of kidney cancer, adding to an earlier clearance in a rare genetic disease.
Pharmaceutical Technology
DECEMBER 15, 2023
The US government is set to receive an additional 230,000 doses of RSV injection Beyfortus from Sanofi and AstraZeneca in January 2024.
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Bio Pharma Dive
DECEMBER 15, 2023
While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.
Pharmaceutical Technology
DECEMBER 15, 2023
The US FDA granted approval for US WorldMeds’ iwilfin for use as an oral maintenance treatment for high-risk neuroblastoma.
Bio Pharma Dive
DECEMBER 15, 2023
Jay Bradner, a well-known physician-scientist who left Novartis last year amid an organizational shakeup, will now serve a Amgen’s chief scientific officer and head of R&D.
Pharmaceutical Technology
DECEMBER 15, 2023
Biovac has received an investment and advisory package from the IFC to support vaccine manufacturing and pandemic preparedness in Africa.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
DECEMBER 15, 2023
Teva Pharmaceutical has signed a licence agreement with Biolojic Design for the development of BD9 to treat atopic dermatitis and asthma.
Fierce Pharma
DECEMBER 15, 2023
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. | Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.
Pharmaceutical Technology
DECEMBER 15, 2023
Reneo’s mavodelpar failed to meet its endpoints in the Phase III trial in primary mitochondrial myopathies, a rare genetic disorder.
Pharma Times
DECEMBER 15, 2023
The funding builds on AstriVax’s €30m in seed funding for its vaccine platform - News - PharmaTimes
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
DECEMBER 15, 2023
This is the second FDA approval for MSD’s HIF-2α inhibitor following a 2021 approval to treat von Hippel-Lindau disease.
Drug Patent Watch
DECEMBER 15, 2023
Annual Drug Patent Expirations for RAPIVAB Rapivab is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are three patents protecting… The post New patent expiration for Biocryst drug RAPIVAB appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
DECEMBER 15, 2023
MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.
Pharma Times
DECEMBER 15, 2023
The combined system works to detect and eliminate airborne pathogens - News - PharmaTimes
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Drug Channels
DECEMBER 15, 2023
This week, I’m rerunning some popular posts while I prepare for today’s Drug Channels Outlook 2024 live video webinar. My topic #9 for 2024: The Battle Over 340B Gets Even Messier. Click here to see the original post from September 2023. Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post.
Pharma Times
DECEMBER 15, 2023
The funding builds on AstriVax’s €30m in seed funding for its vaccine platform AstriVax has announced that it has been awarded a total of €3m in funding from Flanders Innovation & Entrepreneurship (VLAIO) for its therapeutic vaccine targeting chronic hepatitis B. The new funding will bring the company closer to revolutionising therapeutic vaccine development and creating a long-lasting impact in the hepatitis B field.
Drug Patent Watch
DECEMBER 15, 2023
Dasatinib is the generic ingredient in two branded drugs marketed by Apotex and Bristol Myers Squibb and is included in three NDAs. There are two patents protecting this compound. Drug… The post New tentative approval for Teva Pharms drug dasatinib appeared first on DrugPatentWatch - Make Better Decisions.
Pharma Times
DECEMBER 15, 2023
The combined system works to detect and eliminate airborne pathogens A new air-filtering system developed by the University of Glasgow and Pinpoint Medical aims to detect and eliminate airborne pathogens to combat the spread of infections in hospitals. Funded by the UK Research and Innovations’ (UKRI) Engineering and Physical Sciences Research Council (EPSRC), the platform will decontaminate the air of pathogens and measure air quality to ensure a safer and healthier environment.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Drug Patent Watch
DECEMBER 15, 2023
Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma, Strides Pharma, Teva Pharms Usa, Zydus, and Amarin Pharms and, and is included in… The post New tentative approval for Ascent Pharms drug icosapent ethyl appeared first on DrugPatentWatch - Make Better Decisions.
Fierce Pharma
DECEMBER 15, 2023
Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. | Once again, shareholders with the Interfaith Center on Corporate Responsibility are raising access concerns in proposals to several top drugmakers.
Cloudbyz
DECEMBER 15, 2023
Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. Here are several factors that differentiate veterinary clinical trials from human clinical trials: Purpose and Objectives: Veterinary Trials: Primarily focus on testing and developing treatments, drugs, or medical devices for animal health.
pharmaphorum
DECEMBER 15, 2023
MSD claims 2nd FDA approval for Welireg, in kidney cancer Phil.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Drug Patent Watch
DECEMBER 15, 2023
Annual Drug Patent Expirations for TRULANCE Trulance is a drug marketed by Salix and is included in one NDA. It is available from two suppliers. There are eight patents protecting… The post New patent for SALIX drug TRULANCE appeared first on DrugPatentWatch - Make Better Decisions.
CTTI (Clinical Trials Transformation Initiative)
DECEMBER 15, 2023
T oday, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare. “On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan Hanger. “Sally’s tenacity and gift for storytelling have had a remarkable impact on bringing person-centered research and care into the mainstream.
Drug Patent Watch
DECEMBER 15, 2023
Annual Drug Patent Expirations for EVRYSDI Evrysdi is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Genentech Inc drug EVRYSDI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
DECEMBER 15, 2023
The Oxford Vaccine Group (OVG), which led the development of the Oxford vaccine for Covid-19, has been awarded a total of £7.8 ($9.8) million by UK Aid for research into the prevention of five diseases with epidemic or pandemic potential. The awards will fund research into vaccines against Chikungunya and mayaro virus, Marburg virus, Plague (Yersinia pestis), Q Fever (Coxiella burneti) and Sudan Ebolavirus.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Drug Patent Watch
DECEMBER 15, 2023
Annual Drug Patent Expirations for JAYPIRCA Jaypirca is a drug marketed by Loxo Oncol and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Loxo Oncol drug JAYPIRCA appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
DECEMBER 15, 2023
Threats impacting the pharmaceutical industry in 2024 Mike.
Pharmaceutical Commerce
DECEMBER 15, 2023
The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for patients with locally advanced or metastatic urothelial cancer.
pharmaphorum
DECEMBER 15, 2023
Enrolment starts in trial of AI-powered Parkinson’s therapy Phil.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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