Another one BiTEs the dust as Amgen pauses enrollment for phase 1 bispecific trial Lilly investors hungry for news on Alzheimer's drug get a clearer picture of Q4 FDA filing Pfizer's ritlecitinib hits goal in alopecia phase 3, setting up showdown with Lilly Sonoma Bio bags $265M to rev up cell therapies for arthritis, diabetes Marinus hands over EU rights for antiseizure med to Orion in $30M upfront deal Lumosa's stroke drug lowers risk of deadly treatment complication, positioning small biotech to tap into Roche's $1.4B market Zai Lab to pay Schrödinger up to $338M in biobucks for oncology R&D collab Lundbeck bulks up neuro portfolio with $10M Rgenta pact after ditching Alzheimer's drug Pitt's inhalable anti-COVID nanobodies, inspired by llamas, 'remarkably active' against delta variant: study Pfizer, Moderna and Alnylam flag pharma labor shortage in Massachusetts—and the people bottleneck doesn't stop there Philips faces 2nd Class I recall in a month, this time for high-flow therapy ventilators CVS Health sees profit dip to $2.8B in Q2 Featured Story | By Nick Paul Taylor Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical trial of its FLT3 bispecific T-cell engager (BiTE). News of the stoppage comes months after Amgen hit pause on a clutch of other BiTE clinical trials. read more |
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Top Stories By Annalee Armstrong Eli Lilly reaffirmed a plan to submit donanemab to the FDA by the end of the year and said that enrollment has completed for the Trailblazer-ALZ clinical trial during a second quarter earnings call. That phase 3 study will be used to form the package that Lilly will send off to the FDA. read more By Nick Paul Taylor A phase 2b/3 clinical trial of Pfizer’s ritlecitinib in alopecia areata has met its primary endpoint. The update on the JAK3/TEC inhibitor comes months after Eli Lilly and Incyte reported late-phase success in alopecia, setting the stage for a scrap for a potential blockbuster opportunity. read more By Amirah Al Idrus After a modest $40 million debut in early 2020, Sonoma Biotherapeutics is grabbing a whopping $265 million to bankroll a pipeline of cell therapies for autoimmune diseases, including Type 1 diabetes and rheumatoid arthritis. read more By Annalee Armstrong Marinus Pharmaceuticals has offered up the European rights for anti-seizure medicine ganaxolone to Orion Corp. in exchange for a $30 million upfront fee and milestones. Radnor, Pennsylvania-based Marinus could receive up to $115 million later on in milestones and royalties. read more By Kyle LaHucik Patients receiving Lumosa Therapeutics' stroke drug were not at an increased risk of experiencing a serious brain hemorrhage, meeting the main goal of a midstage study and setting up the small biotech to join a billion-dollar market owned by Roche. The main goal of the small phase 2a study was to determine the percentage of patients with acute ischemic stroke who experienced a serious brain bleed called symptomatic intracranial hemorrhage after treatment. read more By Kyle LaHucik Zai Lab will pay Schrödinger up to $338 million in biobucks, on top of an undisclosed upfront payment, for a global R&D pact focused on an oncology program that targets DNA damage response. read more By Kyle LaHucik A month after selling off its discarded Alzheimer's drug candidate, Lundbeck looked to expand its neurology pipeline with another pact, this time linking arms with Rgenta Therapeutics for $10 million upfront and up to $100 million in biobucks. read more By Arlene Weintraub A University of Pittsburgh team studied tiny anti-COVID antibodies derived from llamas to determine how effective they might be at fighting emerging variants, including delta. They discovered that the drugs, called nanobodies, can disarm the virus and its variants using any of three different pathways. read more By Fraiser Kansteiner As COVID-19 vaccine production moves full-tilt, mRNA players Pfizer and Moderna are having trouble recruiting talent in Massachusetts. Hiring challenges, which have been exacerbated by the pandemic, aren’t unique to COVID-19 vaccine makers—and they’re not confined to the Bay State either, local business reports and biopharma executives have warned. read more By Andrea Park The FDA issued its second Class I recall in as many weeks to Philips’ sleep and respiratory care division, offering up its most serious classification for a safety issue that could inadvertently lower the oxygen flow rate in certain ventilators. read more By Paige Minemyer CVS Health's profits took a dip in the second quarter of 2021, where the healthcare giant posted $2.8 billion in earnings. read more | | With the expansion of its DNA services, Cobra Biologics, a Charles River company, has capacity to offer rapid 6-week delivery of HQ plasmids as starting material for clinical evaluation of viral vector mediated immunotherapies. 2021 slots available. |
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