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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
In this week's podcast edition of Five Must-Know Things: landmark results for lecanemab in Alzheimer’s; other Alzheimer’s players rise after the lecanemab results; Leqvio’s importance to Novartis; Pfizer’s secret sauce for digitalization; and Amgen’s clinical trial diversity efforts.
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
The US biotech’s LOXL2 inhibitor candidate has reduced collagen fibrosis of the bone marrow in a small number of Phase II patients, helping validate a historically tricky approach attempted by few.
Axcella’s AXA1125, a therapeutic combination of amino acids, shows liver stiffness, liver enzyme and fat reduction benefits in Phase IIb interim look, but the firm lacks the cash to complete the trial.
Pfizer is buying Biohaven's migraine portfolio, but the rest of the pipeline is poised to be spun out and there have been two development setbacks. Despite verdiperstat's failure in ALS, the field had a same-day win with Amylyx's Relyvrio approval.
The company is seeking FDA accelerated approval of the closely watched gene therapy based on a surrogate marker and has proposed its fully enrolled Phase III trial to serve as a confirmatory study.
New data from anemic myelofibrosis patients showed the drug reduced transfusion dependence, which that could unlock a more sizeable portion of the market for CTI BioPharma.
Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.
The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.
The UK firm with a presence in Boston has just emerged but Pheon’s CEO Bertrand Damour tells Scrip that big pharma is already showing interest in its next-generation antibody-drug conjugate.
Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.
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