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…
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay…
The FDA has issued a complete response letter (CRL) to Reata Pharmaceuticals, rejecting the company’s new drug application (NDA) for bardoxolone methyl for treatment of patients with Alport syndrome-related chronic…
Sanofi and Regeneron added another brick to their joint Dupixent franchise with more phase 3 data confirming the antibody’s benefit in eosinophilic esophagitis, a chronic inflammatory disorder that can increase…