Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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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.