Deaths in Keytruda combo study spur Celyad to pause trial of off-the-shelf CAR-T cell therapy Advantage Pfizer: GSK stops phase 3 trials of maternal RSV vaccine after seeing safety signal UPDATED: Biotech leaders call on industry to cut ties with Russia amid Ukraine invasion Sponsored: The Importance of the Patient in Advancing Care in Rare Diseases Goldfinch's phase 2 kidney disease therapy scores in one indication, misses in another FDA sticks a fork in Reata’s treatment for chronic kidney disease Amryt's shares tumble as FDA stiff-arms skin treatment, a month after EU delay revealed Blueprint marks protein degrader path in $632M biobucks pact with a Vant Huadong buys into Heidelberg, signs nearly $1B deal to gain access to four cancer assets After raking in billions with its COVID shot, Moderna faces patent infringement suit related to vaccine delivery tech Masimo’s brain-monitoring headset nabs FDA nod for use in kids Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer Handheld ultrasound developer Butterfly Network stretches wings to 35% annual sales growth Cerner's 2021 revenue reaches $5.77B as pending Oracle acquisition draws pension fund lawsuit Featured Story | By Nick Paul Taylor Two patients have died after receiving Celyad Oncology’s off-the-shelf CAR-T cell therapy CYAD-101. The colorectal cancer patients had similar pulmonary findings, prompting Celyad to voluntarily pause the trial while it investigates the events. read more |
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Top Stories By Nick Paul Taylor Hopes of a quick fix for GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine woes are fading fast. Having voluntarily paused three maternal RSV vaccine clinical trials 10 days ago, GSK has now stopped enrollment and vaccination in the studies as it works to better understand the safety data. read more By Kyle LaHucik,Annalee Armstrong,Max Bayer,Eric Sagonowsky,Kevin Dunleavy CEOs at dozens of biotechs and investors from the industry's leading venture firms urged their global business counterparts to "disengage from Russian industry" over the weekend. read more Sponsored by: Ipsen Read more to learn about Ipsen's commitment to the rare disease community and to ensuring their patients have a voice. read more By Max Bayer Goldfinch Bio’s kidney disease treatment quelled rising protein levels in patients’ urine, but only in one of the two diseases being tested, according to initial data from a phase 2 trial. read more By Max Bayer The FDA rejected Reata Pharmaceuticals' treatment for chronic kidney disease, a final blow to the company's lead indication for the drug. read more By Annalee Armstrong Amryt can’t catch a break. The U.K. biotech’s shares were sent into the red as the FDA returned a complete response letter for the rare skin disease therapy Oleogel-S10. read more By Kyle LaHucik Blueprint Medicines dives into the protein degradation space in a $632 million biobucks deal with Roivant Sciences' Proteovant Therapeutics. The collaboration initially revolves around two targets, but the deal could double in size if the partners opt into two more. read more By Kyle LaHucik Huadong Medicine will invest about $118 million for a 35% stake in Heidelberg Pharma plus dole out up to $930 million in a licensing deal for four oncology assets. read more By Fraiser Kansteiner Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the mRNA vaccine giant for infringement, but when. Now, the other shoe has dropped. read more By Andrea Park The SedLine system was originally cleared by the FDA in 2004, with the agency’s permission to monitor brain activity while adult patients are under anesthesia. read more By Angus Liu As immuno-oncology agents gradually move in to treat earlier stages of diseases, Bristol Myers Squibb has earned a regulatory boost that could potentially make it the first company to enter a key lung cancer setting. read more By Conor Hale With point-of-care ultrasound probes and subscription plans, the company raked in $62.6 million in 2021 compared to 2020's $46.3 million. read more By Heather Landi Two months after Oracle announced plans to buy Cerner, the health IT company is now being sued by a pension fund over concerns that the company's leadership "stymied potential bidders" while pushing forward a deal with Oracle and didn't explore other alternatives. read more Resources Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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