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The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
Read about TFF Pharmaceuticals and Augmenta Bioworks’ dry powder COVID-19 antibody formula, the world’s first gene editing clinical trial for PKU, Bayer’s COVID-19 vaccine and other key developments in life sciences research.
The project will be one of the largest construction projects in North Carolina, with about 2 million sq. ft. of space. It is expected to bring in 725 new jobs in Wake County over the next five years.
Facing thousands of lawsuits related to its talc-based products, life sciences giant Johnson & Johnson is launching a separate subsidiary dubbed LTL Management LLC that will take the brunt of potential legal liabilities.
It was yet another busy week for clinical trial announcements. Take a look.
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ran from October 13 to 15, with companies globally presenting cutting-edge studies on MS.
Cepharanthine reproducibly demonstrates potential as a monotherapy in treating multiple cancers with unsatisfactory treatment options.
Merck is getting its chance at participating in the pandemic. The FDA has announced an outside expert panel will meet on November 30 to deliberate on Merck’s COVID-19 pill.
They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
Genomics veteran Bob Ragusa is taking over GRAIL, a newly-acquired business unit of Illumina, Inc. He is taking over as CEO Hans Bishop steps down from his role.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
