FDA Advisory Panel Rejects Pfizer's Talzenna Expansion, Sarepta Resumes Duchenne Study

In a significant setback for Pfizer, the Food and Drug Administration's advisory panel unanimously voted against expanding the use of Talzenna in prostate cancer patients. Meanwhile, Sarepta Therapeutics received clearance from UK regulators to resume its Duchenne muscular dystrophy gene therapy trial. These developments, along with other industry news, highlight the ongoing challenges and advancements in the pharmaceutical sector.

Pfizer Faces Setback in Prostate Cancer Treatment

An eight-member FDA advisory panel voted unanimously against broadening the use of Pfizer's PARP inhibitor, Talzenna, in metastatic prostate cancer patients. The panel concluded that Pfizer's data were insufficient to support Talzenna's benefits in patients without specific "homologous recombination repair" mutations.

Talzenna was previously approved in 2023 for use alongside Xtandi in prostate cancer patients with these specific genetic alterations. Pfizer had hoped that additional survival data gathered since the initial approval would convince the FDA to expand treatment to all newly diagnosed metastatic prostate cancer patients.

Sarepta's Duchenne Study Resumes After Safety Review

UK health authorities have given Sarepta Therapeutics the green light to continue dosing in the Envision trial, which is testing the company's gene therapy Elevidys in Duchenne muscular dystrophy patients. This decision comes after a temporary pause in March following the death of a trial participant from acute liver failure.

The resumption of the study is seen as a positive signal for how regulatory bodies, including the FDA and European Medicines Agency, may view Elevidys moving forward. The trial focuses on both ambulatory and non-ambulatory patients with Duchenne muscular dystrophy.

BioNTech Commits to Major UK Investment

BioNTech announced plans to invest up to £1 billion (approximately $1.34 billion) in drug research in the United Kingdom over the next decade. As part of this initiative, the company will receive up to £129 million in grant funding from the UK government, one of the largest grants ever awarded to a pharmaceutical company in the country.

The investment will facilitate the establishment of two new R&D centers, including one in Cambridge, England, focusing on genomics, oncology, and other research priorities. Additionally, BioNTech will set up its UK headquarters in London, further solidifying its presence in the country's biotech landscape.

Industry Acquisitions and Collaborations

Altos Labs, a well-funded startup in the aging research field, has acquired Dorian Therapeutics, a privately held company based in San Carlos, California. This acquisition allows Altos Labs to incorporate Dorian's cellular rejuvenation research into its ongoing studies on the biological basis of aging and its relationship to disease.

The integration of Dorian's expertise, which originated from research at the Stanford University School of Medicine, is expected to bolster Altos Labs' efforts in understanding and potentially reversing the aging process.