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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Although it’s not yet clear how dangerous the Omicron variant of COVID-19 actually is, it clearly is very infectious and rates are rising in the U.S. and around the world.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
The JP Morgan Health Care Conference is held annually in January, and usually kicks off the biggest biopharma business news stories of the year. But in 2022, it’ll do so without at least three big names in the industry.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.
Novartis has grown weary of waiting, dropping out of its deal to fund Mesoblast’s floundering COVID-19 treatment.
The lawsuit was filed by Public Health and Medical Professionals for Transparency, a nonprofit organization recently formed with a mission to obtain the data for the COVID-19 vaccines.
Despite the biggest vaccination drive in the U.S., the pandemic is still not over. The U.S. has reported more than 800,000 COVID-19 deaths, an increase of 500,000 since the vaccination started.
The 63rd ASH Annual Meeting and Exposition is wrapping up today, with dozens providing updates on clinical trials and preclinical research. Here’s a highlight of just a few of those stories.
Cidara Therapeutics and Mundipharma today shared positive topline results from their Phase III trial on the use of rezafungin for candidemia and invasive candidiasis.