Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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CG Oncology presented positive interim Phase II results for its Core1 trial studying the use of CG0070 at the American Association for Cancer Research (AACR) Annual Meeting.
Bristol Myers Squibb and Nektar Therapeutics ended their global clinical program for potential bladder cancer and renal cell carcinoma treatment.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
The revised operating plan also includes reductions in spending related to general and administrative expenses and investments in its research platform.
Drug pricing watchdog ICER issued a draft report on bluebird bio’s gene therapy betibeglogene autotemcel for beta-thalassemia. The report touted the therapy’s cost-effectiveness.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
The AACR annual meeting concluded on April 13, showcasing hundreds of preclinical to late-stage information from ongoing studies on treatment candidates.
ProQR Therapeutics, which is developing RNA therapies for genetic eye diseases, announced Wednesday that it will be restructuring and laying off 30% of its staff.