Novartis, BeiGene's PD-1 drug the latest to hit FDA wall as pandemic stalls another review European probe into Illumina’s Grail deal can proceed, EU court rules Summit will take scenic route up FDA mountain after regulator recommends more trials for C. diff therapy Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management DOJ files False Claims Act case against dialysis giant Fresenius alleging unnecessary vascular procedures In pursuit of Bayer and Regeneron's Eylea, Roche shows Vabysmo's superior staying power Marinus parts with priority review voucher, selling skip-the-line pass to Novo Nordisk for $110M Novartis links up with Mayo Clinic spinout Anumana to develop ECG-reading AI Manchin reluctant to add ACA subsidy extension to narrow spending deal BMS, Merck and Lilly share prices gained in the first half, while Roche, Pfizer and Moderna lost out: report Medtronic’s AI-powered spine surgery planning platform lands updated FDA nod An approved drug may already exist to counter chromosome-cased heart failure risk in older men Northwell Health inks deal with Google for cloud, AI technologies CytomX slashes headcount by 40% after breast cancer setback, with later-stage development bearing the brunt Featured Story | By Angus Liu New PD-1 cancer immunotherapies have had a hard time reaching the U.S. lately. For Novartis and BeiGene’s China-approved contender, the roadblock comes in the form of COVID-related travel restrictions. read more |
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Top Stories By Conor Hale The EU General Court ruled Wednesday that the European Commission can investigate the $8 billion acquisition, rejecting Illumina’s argument that the probe should be denied on the grounds that Grail currently does no business on the continent. read more By Annalee Armstrong Summit Therapeutics’ troubled C. difficile medicine may have a path forward after the FDA cleared a section of trail—however, it’s going to be a steep climb. read more Sponsored By: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By Heather Landi Two doctors allege in a lawsuit that the country's largest dialysis provider performed potentially thousands of unnecessary, invasive vascular procedures on end-stage renal patients and fraudulently charged Medicare and Medicaid. read more By Kevin Dunleavy After two years on Roche's Vabysmo, more than 60% of wet age-related macular degeneration (AMD) patients could be treated every four months. The data, which were presented at the American Society of Retina Specialists annual scientific meeting, show that Vabysmo has an advantage over Bayer and Regeneron powerhouse AMD drug Eylea. read more By Max Bayer Marinus is selling off a priority review voucher to Novo Nordisk for $110 million. The company plans to use the additional funds to pay for two ongoing phase 3 trials and the launch of its new seizure med, Ztalmy. read more By Andrea Park Together, Novartis and Anumana plan to build algorithms that analyze electrocardiogram readings for signs of cardiovascular disease that would be missed by human physicians. read more By Robert King Centrist Sen. Joe Manchin, D-West Virginia,, is reluctant to support adding an extension to enhanced ACA subsidies in a narrow spending package that already includes a landmark drug pricing reform deal. read more By Zoey Becker Like many other businesses around the world, the biopharma industry has had a rough go of it in the first half of 2022. And drugmakers' share price changes largely reflected that tough environment, Evaluate Vantage reports. read more By Andrea Park Medtronic's newly cleared AI algorithm has been designed to guide surgeons through the planning process for lower lumbar spine procedures, while also predicting the compensatory mechanisms that the body will produce in response to the procedure for six months afterwards. read more By James Waldron One of the major causes of increased heart failure risk in older men is the loss of the Y chromosome in immature blood cells called hematopoietic cells. Now, researchers have suggested an already approved drug could be the solution. read more By Heather Landi Northwell Health will be tapping Google's cloud, artificial intelligence and machine learning technologies to develop new predictive analytics capabilities around patient care and operations. read more By Nick Paul Taylor First the setback, then the cuts. CytomX Therapeutics became the latest biotech to follow the rhythm of the industry late Wednesday when it set out plans to reduce its headcount by 40% to extend its cash runway after its lead candidate failed to meet the bar for moving into phase 3. read more Resources Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? | 