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.
FEATURED STORIES
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 placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Speculations that Biogen might appeal the decision after reports of the company hiring several lobbyists, including Clyburn Consulting and Federal Street Strategies.
Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Since its $63 billion acquisition of Allergan in 2019, AbbVie has become one of the leading companies developing therapies for migraine.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
A roundup of last week’s top clinical trial updates and news.