Flagship Pioneering Inc. and Profound Therapeutics Inc., a Flagship-founded company, have announced a collaboration to conduct foundational research to identify potential next-generation first-in-class therapies for the treatment of obesity.
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
A boy participating in the phase II Daylight study of Duchenne muscular dystrophy (DMD) “has passed away suddenly,” according to Pfizer Inc. The participant had received fordadistrogene movaparvovec, a mini-dystrophin gene therapy, in early 2023. The fatal serious adverse event was reported May 3 as a cardiac arrest, Pfizer told BioWorld. Pfizer, together with the independent external data monitoring committee, is reviewing the data to understand the potential cause, the company added.
Pfizer Inc. has divulged 17-β-hydroxysteroid dehydrogenase 13 (HSD17B13; 17- β-HSD 13) inhibitors and/or degraders reported to be useful for the treatment of hepatocellular carcinoma, biliary cirrhosis, hepatitis B and hepatitis C viral infections, alcoholic and nonalcoholic fatty liver disease, among others.
Ten days early, the U.S. FDA granted full approval under priority review to Pfizer Inc. and Genmab A/S’s antibody-drug conjugate Tivdak (tisotumab vedotin) to treat cervical cancer.
The government of Colombia, after signaling its intent to do so at the end of 2023, issued a compulsory license on April 24 for access to generic versions of HIV drug dolutegravir, without the permission of patent owner Viiv Healthcare Ltd.
Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).
Pfizer Inc. has described serine/threonine-protein kinase (SIK) inhibitors reported to be useful for the treatment of arthritis, cancer, osteoporosis, atherosclerosis, inflammatory bowel disease, autoimmune diseases, inflammatory disorders and pain.
