News
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
FEATURED STORIES
Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.
Actinium Pharmaceuticals’ Iomab-B met the primary endpoint in the Phase III SIERRA trial, demonstrating durable Complete Remission at six months.
On Friday, the FDA approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) as the first treatment for geographic atrophy (GA), a leading cause of blindness.
Takeda’s vedolizumab met its primary endpoint in the Phase III GRAPHITE study, significantly improving event-free survival in patients with acute graft-versus-host disease.
Hemab Therapeutics announced the closing of an oversubscribed Series B round to bring new treatment options for lesser-known bleeding disorders.
The FDA granted accelerated approval Friday to Travere Therapeutics’ sparsentan, now to be marketed as Filspari, to reduce the burden of proteinuria in adults with primary IgA nephropathy.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Moderna announced mixed interim results Thursday from a Phase III trial of mRNA seasonal flu vaccine candidate, mRNA-1010.
Pfizer and Valneva are dropping approximately half of enrolled participants in the Phase III VALOR study for their Lyme disease vaccine candidate, VLA15.