Drug Development
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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THE LATEST
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.