FDA rejects Gilead's would-be blockbuster filgotinib over toxicity concerns FDA gets out its red pen again, rejecting BioMarin's gene therapy valrox amid durability worries J&J inks $6.5B Momenta buyout to bag autoimmune drug Sponsored: Why Ethical Procurement Matters for Human Biospecimens FDA halts COVID-19 blood plasma emergency approval Rome snags Merck, Celgene vet Zaller as new CSO Albireo drops fatty liver program after ‘unremarkable results’ FDA flags accuracy issues with Thermo Fisher's COVID-19 test kit and software Featured Story | By Nick Paul Taylor The FDA has rejected Gilead’s filing for approval of filgotinib in rheumatoid arthritis. With the FDA asking to see data from an ongoing clinical trial, Gilead is unlikely to be able to refile until toward the middle of next year, pushing it still further behind its rivals for the JAK inhibitor market. read more |
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Top Stories By Ben Adams BioMarin’s shares plummeted in early Wednesday trading after the FDA refused to approve its hemophilia A gene therapy valoctocogene roxaparvovec. read more By Nick Paul Taylor Johnson & Johnson has struck a deal to buy Momenta Pharmaceuticals for $6.5 billion. The takeover will give J&J control of an anti-FcRn antibody that completed a phase 2 trial in myasthenia gravis earlier this year. read more By BioIVT While the response to COVID-19 and other disease indications drives science forward, regulatory guidelines that ensure the safe and ethical treatment of patients continues to be critically important. read more By Ben Adams As the FDA was prepping to allow emergency use of blood plasma donation from recovered COVID-19 patients, government officials have put pay to that. read more By Amirah Al Idrus Four months after launch, Rome Therapeutics has hired a new chief scientist. Dennis Zaller, Ph.D., arrives at the startup from Celgene, where he spent five years overseeing partnerships with early-stage biotechs across immunology, fibrosis and immuno-oncology and ushering six new drugs into the clinic. read more By Amirah Al Idrus Last year, Albireo CEO Ron Cooper painted elobixibat, a drug approved in Japan for constipation, as one arm of a two-pronged strategy to fight fatty liver disease. Now, the company is down to one prong, as the program failed the move the needle on nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) in a phase 2 study. read more By Conor Hale The FDA has flagged two issues with Thermo Fisher Scientific’s molecular diagnostic for COVID-19 that could lead to inaccurate results. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked! N/A Drug Development Boot Camp® VIRTUAL 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now | Due to COVID19 provisions – training will be conducted VIRTUALLY | Same excellent total immersion training in new medicine development will be made available to experts who want to make a difference to patients. | 