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Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.
In response to skyrocketing demand for its weight-loss drug Wegovy, Novo Nordisk announced Friday it is investing more than $6 billion to expand production capacity in its home country of Denmark.
The two mid-stage flops—one in major depressive disorder and another in focal onset seizures—involve drug candidates from partnerships with Xenon Pharmaceuticals and Takeda, respectively.
The biopharma’s Adzynma, a human recombinant ADAMST13 therapeutic, is the first approved therapy for the ultra-rare clotting disorder congenital thrombotic thrombocytopenic purpura.
Over the next two weeks, the FDA is set to decide on New Drug Applications from Pacira, CorMedix and Aldeyra and hold an advisory committee meeting for two overdue confirmatory trials from Acrotech.
The Federal Trade Commission is challenging over 100 pharmaceutical patents held by prominent drugmakers, including AbbVie, AstraZeneca and Boehringer Ingelheim, for their listings.
As Vertex and CRISPR Therapeutics await the monumental potential approval of exa-cel, bluebird bio, Iovance and Rocket Pharmaceuticals wait patiently in the wings.
While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings.
The vaccine maker is prepared to cut another $300 million in operating expenses in 2024 to keep the company afloat as it works to get its combination COVID-19/flu vaccine into Phase III.
In a bid to join Eli Lilly and Novo Nordisk in the lucrative, high-growth obesity market, AstraZeneca is investing in a Phase I oral GLP-1RA candidate from Shanghai-based biotech Eccogene.
Citing manufacturing concerns and formulary losses, Novo Nordisk will discontinue its long-acting insulin Levemir by the end of next year amid strong pressure from U.S. lawmakers to lower insulin prices.
The oral targeted therapy, now sold under the brand name Fruzaqla, is approved for adults with metastatic colorectal cancer who have received certain previous treatments for the disease.
PRESS RELEASES
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025