Drug Development
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
FEATURED STORIES
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
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AstraZeneca has been struggling to find an effective use for its anti-CTLA-4 antibody tremelimumab. It may have finally found it.
A checkpoint inhibitor under development from China’s CStone Pharmaceuticals hit the mark in a Phase III non-small cell lung cancer study.
A study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19.
The FDA issued the partial clinical hold order in response to the IND application Yumanity submitted in December last year. The company expects additional data on the directive within the next 30 days.
The new pancreatic cancer vaccine from ImmunityBio shows very promising results. Here’s what you need to know about the vaccine and its result from the tests.
Werewolf Therapeutics is designing and developing molecules that unleash the natural ferocity of cytokines for the treatment of cancer.
Moderna is poised to commercialize its COVID-19 and influenza combination vaccine by the fall of 2023, with some potential for the same drug to also be viable against the RSV.
The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.
Amagma Therapeutics announced a licensing agreement with Innovent Biologics for up to three enzyme specific inhibitors derived from Amagma’s proprietary SEIZMIC Platform.
The company will continue to analyze data regarding the secondary endpoints.