Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
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Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The decision comes after the FDA put NUV-422, its candidate for high-grade gliomas, on a partial clinical hold, citing safety concerns.
The ongoing AAIC 2022 in San Diego has delivered positive news for the AD space. We look at updates from Vivoryon, Anavex and Argentinian scientists below.
Marengo Therapeutics and Ipsen have entered into a strategic, multi-year partnership to usher two of Marengo’s precision T cell immuno-oncology candidates into the clinic.
The BLA is for the use of the drug N-803 with BCG to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma with or without Ta or T1 disease.
Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as an adjuvant treatment for localized renal cell carcinoma (RCC) failed to hit the primary endpoint.
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.
InMed updated its INM-755 for patients with epidermolysis bullosa, Seagen and Astellas announced positive topline results for Padcev with Merck’s Keytruda, and more.
COVID-19 has been remarkably profitable for Pfizer over the last year-and-a-half. The company’s revenue jumped by 47% to $27.7 billion compared to the same period in 2021.
The DESTINY-Breast04 trial introduces a new option for breast cancer diagnosis – HER2-low. The trial data received a standing ovation from thousands of oncologists at this year’s ASCO meeting.