Therapies based on the human gut microbiome are in the news with one company, Osel, releasing encouraging phase 1b data and another, Finch, receiving an FDA clinical hold during a…
Dozens of leaders in the global life sciences community are among the many who have signed an open letter condemning Russia’s invasion of Ukraine, calling it a “barbaric act that…
Antibody developer Adagene has forged a collaboration and exclusive license agreement with Sanofi to make masked monoclonal and bispecific antibodies. Source: Drug Industry Daily
The FDA has issued a Complete Response Letter (CRL) to Gilead Sciences for its new drug application (NDA) for lenacapavir, an HIV-1 capsid inhibitor for patients with HIV who are…
The FDA has released final guidance for industry on the agency’s approach for overseeing requests for the importation of unapproved finished dosage form drugs by applicants preparing medicines for market…
AbbVie has completed its acquisition of Belgium-based Syndesi Therapeutics, broadening its neuroscience portfolio with several candidate drugs for treating a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease…
Pfizer is putting a positive spin on a C. difficile vaccine study that missed its two primary endpoints but scored some wins on secondary targets. Source: Drug Industry Daily
A U.S. Patent and Trademark Office tribunal that oversees patent disputes has ruled that patents on CRISPR technology belong to Harvard University and the Massachusetts Institute of Technology’s Broad Institute…
Carvykti, a new CAR-T cell therapy developed by Legend Biotech and Janssen, is now approved for patients with relapsed or refractory multiple myeloma who have already received four or more…
A biologics-focused subsidiary of Bangalore, India-based Biocon is buying the biosimilars portfolio of Pittsburgh, Pa.-based Viatris for up to $3.3 billion. Source: Drug Industry Daily