The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi. Eisai said it will ask the committee to reconsider the negative opinion.
Ajinomoto’s Forge Biologics acquisition brings contract development and manufacturing organization capabilities in gene therapy. Forge specializes in manufacturing AAV vectors used to deliver these therapies.
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The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
Astellas Pharma has identified targeted protein degradation as one of the key areas for growth. The PeptiDream alliance is the latest one Astellas has struck in this particular area of drug research as it aims to find new ways to go after difficult cancer targets.
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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Astellas Pharma won FDA approval for Veozah, a new menopause drug. The once-daily pill offers a new non-hormonal treatment option for addressing menopausal symptoms.
Eisai gains an option to license a Bliss Biopharmaceutical drug that targets HER2, a cancer protein that has become a hot target for addressing several types of solid tumors. BlissBio could receive up to $2 billion in milestones and other payments.
Astellas Pharma is acquiring Iveric Bio in a deal that brings a vision loss-disorder drug on track for an FDA decision this summer. Iveric’s pipeline also includes genetic medicines that fit Astellas’s gene therapy strategy.
Takeda Pharmaceutical drug TAK-279 achieved the main goal of a mid-stage clinical trial in plaque psoriasis, setting the stage for Phase 3. The Japanese pharmaceutical giant sees the small molecule as complementary to its top-selling product, the blockbuster inflammatory bowel disorder drug Entyvio, and competitive against Bristol Myers Squibb's Sotyktu.
A new independent study from Phyx Primary Care’s Innovation Lab points to measurable improvements in physician burnout, documentation efficiency, and key VBC metrics among primary care practices.
Leqembi, the Eisai Alzheimer’s disease drug awarded accelerated FDA approval in January, could receive a decision on full approval in early July. But in setting the target date for a regulatory decision, the agency also said it plans to convene an advisory committee meeting to discuss the drug.
Astellas has become an active player in gene therapy. MedCity News caught up with company executive Richard Wilson, who explained Astellas’s strategy, the clinical holds on its two most advanced programs, and the rationale behind its recent gene therapy deals.
Astellas has purchased an equity stake in Taysha Gene Therapies in a $50 million deal that gives it an option to license the company’s two lead gene therapy candidates. The Japanese pharmaceutical giant also gains the option to buy its new partner outright depending on clinical and regulatory developments expected in the coming year.
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.