The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said. Read More
Idorsia Ltd. looks on course to produce another marketed drug after supportive phase III results for its hypertension drug, aprocitentan. The company’s first U.S. FDA-approved drug, Quviviq (daridorexant), was launched in April and another product, Pivlaz (clazosentan), was approved and launched in April for cerebral vasospasm in Japan. Read More
Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market. Read More
Concert Pharmaceuticals Inc. is on track for an NDA filing for CTP-543 in alopecia areata during the first half of 2023, following a positive read-out from the first of two phase III trials of the oral Janus kinase 1/2 inhibitor. The molecule hit the primary endpoint of the placebo-controlled Thrive-AA1 study, which was defined as the percentage of patients achieving a SALT (Severity of Alopecia Assessment Tool) score of 20 or less after 24 weeks of therapy. Read More
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs. Read More
Although it was recently overturned in a legal challenge, a short-lived California state law mandating gender quotas for corporate boards may have made a few drug and device companies based in the state think twice about the makeup of their boards. Read More
New hires and promotions in the biopharma industry, including: Ascendis, Bioage, Elevar, Enlivex, Insmed, Mind Medicine, Nouscom, Orphazyme, Praxis, Relief, Salubris, Tentarix. Read More
New and updated preclinical and clinical data presented by biopharma firms at Digestive Disease Week 2022, including: Albireo, Cymabay, Evoke, Fractyl, Seres. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Aptamer, Cantargia, Catalyst, Elicio, Entasis, Immunocore, Immunome, Innoviva, Kala, Lupagen, Medison, Mirum, Pharmacyte, Pinotbio, Quoin, Satiogen, St. Jude, Umoja and Vertex. Read More
