Drug Development
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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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.
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.
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The findings may have far-reaching consequences for any COVID-19 vaccines in development that are based upon targeting the well-conserved SARS-CoV-2 nucleocapsid (N-) protein.
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.
Full results from the Phase III trial of Novavax’s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
With the holidays around the corner and people expected to gather, public health officials have expressed concerns over a possible increase in COVID-19 cases, particularly with the highly infectious Omicron variant on the rise.
In a unanimous vote made by U.S. health officials, the advisers decided the safer Pfizer and Moderna vaccines should be given as boosters.
The avalanche of news released every day about all three - or various combinations thereof - can be overwhelming. So, BioSpace has put together a chart for easy comparative reference.
The agreement between the two companies includes a lead, potential first-in-class preclinical candidate, and research collaboration to jointly develop the additional novel candidates.
A recent study estimates that in the U.S. alone the vaccines saved 1.1 million lives and prevented 10.3 million hospitalizations. For that and more COVID-19 news, continue reading.
Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.