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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The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.
Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
Eli Lilly is planning to launch its blockbuster diabetes drug Mounjaro next year in India, the world’s most populous nation, ahead of its main competitor Novo Nordisk which is eyeing an Indian launch of Wegovy in 2026.
Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool.
Incannex Healthcare on Wednesday said its investigational psychedelic psilocybin met the primary endpoint, demonstrating it can reduce Hamilton anxiety scores by more than nine points versus placebo.
Electronic consent can personalize the patient experience in clinical trials and even improve retention. At Medable, where I am CSO, we’re committed to driving the adoption of this transformative technology.
Under the research and development agreement announced Wednesday, Viatris is securing global rights to Idorsia’s late-stage heart and lupus candidates.
The vaccine maker’s fourth-quarter revenue and earnings on Wednesday missed Wall Street expectations, while providing full-year 2024 sales guidance of flat to lower than last year.
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.