Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation. Read More
Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints. Read More
Astrazeneca plc led the handful of firms rolling out COVID-19-related news, as the company said detailed results from the Provent phase III pre-exposure prophylaxis (prevention) trial with Evusheld (tixagevimab and cilgavimab), were published in the New England Journal of Medicine, the “culmination of about 19 months of pretty intensive work,” said Mark Esser, vice president of microbial sciences. Read More
Alexion Pharmaceuticals Inc. has demonstrated the commercial potential for rare disease drugs with its complement inhibitor Soliris (eculizumab) and long-lasting follow-up Ultomiris (ravulizumab) driving blockbuster sales. A host of other companies are hoping to compete with Ultomiris, which is U.S. FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Read More
The U.S. FDA wants feedback on its latest idea to reduce the number of unused prescription opioids shelved in American homes: requiring prepaid mail-back envelopes to be dispensed with the painkillers. Read More
South Korean companies Ubix Therapeutics Inc. and SK Biopharmaceuticals Co. Ltd. are partnering to develop targeted protein degradation cancer therapies. Read More
After failing to meet primary safety and efficacy endpoints in a phase I/II trial for stroke, Teijin Ltd. and JCR Pharmaceuticals Co. Ltd. have terminated a co-development and Japan licensing agreement to develop JTR-161, an allogeneic regenerative candidate containing dental pulp stem cells. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcturus, Bavarian Nordic, Clover, Fibrogen, Navidea, Otonomy, Snipr, Trevena, Ultragenyx, Windtree. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aim Immunotech, Biogen, Blue Water Vaccines, Humanigen, Immvira, Roche, Samsung Bioepis, Selva, Sihuan Pharma, Tonix, Xortx, Xuansheng Pharma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, JW, Keymed, Teva. Read More
