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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Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.
As the Omicron variant of the SARS-CoV-2 virus sweeps much of the globe, scientists are digging into why this particular mutation is spreading even more rapidly than its predecessors.
Nodexus and Aramis Biosciences will use their funds to expand their company’s pipeline and build their commercialization capabilities.
Researchers have published a study describing how chemotherapy and a drug used to treat cardiac failure is able to regress tumor growth of patients with triple negative breast cancer.
Biopharmaceutical companies across the world are fighting an increasingly important battle against COVID-19: the struggle to treat the disease.
The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
Sanofi and GlaxoSmithKline reported that their potential COVID-19 booster shot delivered good immune response in its preliminary clinical trials.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
Although it’s not yet clear how dangerous the Omicron variant of COVID-19 actually is, it clearly is very infectious and rates are rising in the U.S. and around the world.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.