Drug Development
Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.
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After emraclidine’s schizophrenia fail and Cobenfy’s laggard launch, it’s too early to know who made the better buy: AbbVie, in its $8.7 billion Cerevel takeover in late 2023, or Bristol Myers Squibb, which spent $14 billion for Karuna just two weeks later.
Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
To build on the momentum in MASH, we—at Madrigal Pharmaceuticals and the industry more widely—must further expand approaches to diagnosis, monitoring and individualized treatment to help more patients.
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Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgensma or for the pharma’s similar product Itvisma.
At the American Heart Association conference, investigators were supportive of further studying Novo’s IL-6 inhibitor ziltivekimab in patients with less severe cardiovascular and kidney disease.
SK pharmteco’s Tatiana Nanda, chief technical officer of SK pharmteco Viral Vector North America discusses what gene therapy sponsors must account for sooner rather than later when preparing for GMP manufacturing.
After the FDA delayed a decision for Agios Pharmaceuticals’ sickle cell disease candidate, the biopharma is letting go of more than 35% of its R&D employees.
Personalized cancer vaccines are getting closer to market. Merck and Moderna just showed successful manufacturing in a large Phase 3 trial, proving they can deliver the goods.
Pent-up demand for the new pancreatic cancer therapy Rasonque helped RevMed soar past analysts’ sales expectations and reach 5,000 patients in the third quarter.
With backing from three Big Pharma investment arms, British biotech T-Therapeutics is brewing up a clinical launch for its cancer and autoimmune T cell engagers.
Evommune is commiting $30 million upfront for Hinova Pharmaceuticals’ oral molecular glue degrader—a low-cost bet with a high probability of success, according to analysts, after clinical failures roiled the biotech’s internal pipeline earlier this year.
In this episode of Denatured, you’ll hear from from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral therapies trigger systemic anticancer immunity from a local injection, and redefine a foundational platform in immuno-oncology.