In the year’s second biggest M&A deal, Merck & Co. Inc. will take over pulmonary and hematologic specialist Acceleron Pharma Inc. for $11.5 billion. The acquisition brings Merck a pair of potential blockbuster drugs, one of them already marketed. There is sotatercept, in development for treating pulmonary hypertension (PH), and also Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent approved in the U.S., Europe and Canada for treating anemia in certain blood disorders. Read More
Cell therapy developer Cellular Biomedicine Group Inc. (CBMG) completed a $120 million series A financing, its first since becoming a private company. The funds will benefit the U.S. and China-based firm’s CAR T pipeline, and the round was jointly led by Astrazeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital. Existing investors including GIC Private Ltd. (formerly Government of Singapore Investment Corp.) and TF Capital also took part. Read More
As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field. Read More
LONDON – It is both safe and effective for people to receive an influenza vaccine at the same time as a COVID-19 vaccine, with no negative impacts on the strength of the immune response produced by either vaccine and reported side effects mainly mild to moderate. Only nine of 679 participants in a U.K. study testing combinations of different flu and COVID-19 vaccines said they would not want to have two different vaccines at the same time in the future. Six of those were in the control arm of the trial, in which saline was injected as a placebo. Read More
New data on the COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), already used to treat non-hospitalized patients in multiple countries, could potentially support expanding its use to certain recently hospitalized patients with the disease. Read More
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30. Read More
Despite shouldering a quarter of the global disease burden, Africa is responsible for only 2% of the world research on new infections. Aiming to bolster R&D in the region, the H3D-Foundation and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) launched a three-year partnership to strengthen capacity for health innovation in Africa. Read More
New hires and promotions in the biopharma industry, including: Arch, Elios, Genenta, Hangzhou Chance, Hibercell, Immunicum, Immunos, Isarna, Medicenna, Merck, Mind Medicine, Nurix, Obseva, Pharmather, Synairgen, Targovax, XNK. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Academy of Dermatology and Venereology Congress, including: Abbvie, Arcutis, BMS, Dermavant, Eli Lilly, Leo, Novartis, Rapt, Sanofi. Read More
New and updated preclinical and clinical data presented by biopharma firms at IDWeek 2021, including: Allovir, Codagenix, Ferring, Humanigen, Iliad, Mycovia, Neoleukin, Peptilogics, Scynexis, Seqirus, Viiv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Acacia, Alnylam, Amicus, Bridgebio, Catalyst, Eli Lilly, Everest, Helsinn, Pharmazz, Recursion, Taysha. Read More
