With the FDA approval of Scemblix (asciminib), a STAMP inhibitor for treating chronic myeloid leukemia (CML) in adults, Novartis AG has a companion to its longstanding therapy Gleevec (imatinib) as a treatment for the indication. Read More
Abbvie Inc.’s FDA clearance of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, could bring relief to about 128 million Americans: almost half of the U.S. population, the company said. It’s the first and only eye drop given U.S. regulators’ go-ahead for what’s known as age-related blurry near vision – but plenty more have generated clinical data. Read More
Merck & Co. Inc. has signed a potential $1 billion research tie-up with Synthekine Inc. to develop engineered cytokines to fight autoimmune diseases, as its $11.5 billion merger with Acceleron Pharma Inc. hit a regulatory speed bump. Read More
An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men. Read More
As booster shots become increasingly available and COVID-19 vaccines for young children are introduced into pediatric offices, several potential therapeutics to battle the SARS-CoV-2 virus are lining up for regulatory authorizations. Read More
Shanghai Pharmaceutical Holding Co. Ltd. out-licensed global rights of its antitumor small-molecule chemical drug, SPH-6162, to U.S.-based Huya Bioscience International LLC in a deal worth up to $292.5 million, plus a sales commission of 3% to 6%. Read More
Aculys Pharma Inc. closed its $60 million series A financing round, with the funds to be used to develop pitolisant (Wakix), a selective histamine H3 receptor antagonist/ inverse agonist, in Japan. Read More
Biopharma scored a victory of sorts in the ongoing 340B war that’s pitting drug companies against the combined forces of hospital groups, contract pharmacies and the U.S. Department of Health and Human Services. Read More
The U.S. Department of Justice (DoJ) reported a new set of policies dealing with federal prosecutions of corporate misconduct that includes a far-reaching policy on disclosure. Deputy attorney general Lisa Monaco announced Oct. 28 that companies will have to disclose all non-privileged information in connection with alleged misconduct rather than just information regarding those who were “substantially involved.” Read More
A former sales rep for Cambridge, Mass.-based Aegerion Pharmaceuticals Inc. was sentenced Oct. 28 to 54 months in prison and three years of supervised release for a scheme to defraud insurance companies and boost his bonuses for sales of Aegerion’s cholesterol drug, Juxtapid (lomitapide). Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ANI, Antengene, Bionomics, Biontech, Cocrystal, Coherus, Gannex, Hyloris, Incyte, Immutep, Junshi, Medac, Medexus, Moderna, Novartis, Novavax, Orphazyme, Pfizer, Sesen, Sio Gene, Sorrento, Synthekine, Theseus. Read More
