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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The FDA amended its EUA for GlaxoSmithKline and Vir Biotechnology’s sotrovimab for COVID-19. The amendment relates specifically to the BA.2 Omicron sub-variant.
COVID-19 vaccines are the most-studied vaccines in history. This is partly why some data can appear so contradictory. For those and more COVID-19 stories, continue reading.
Although some may be hopeful that the end of the COVID-19 pandemic is nearby, millions still are facing their own lifelong version of the pandemic.
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
The 2022 American Academy of Dermatology Annual Meeting saw several milestones for treatment explorations for inflammatory diseases. Here is some of the major news:
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
COVID-19 cases are soaring in China, Hong Kong, the U.K. and parts of Europe. A recent Demy-Colton Virtual Salon explored what we can expect in the near future.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Seattle-based Icosavax’s stock plunged 50% after the company reported topline interim data from its ongoing Phase I/II COVID-19 vaccine trial.