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, 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. Holding onto 2021’s biggest deal is July’s $39 billion Alexion Pharmaceuticals Inc.-Astrazeneca plc merger, and it remains as the No. 3 all-time M&A among biotech developers. The new Merck-Acceleron agreement ranks at No. 17 among the top 20 all-time deals, according to BioWorld statistics.

CBMG bags $120M in its first financing since going private, funds to benefit CAR T candidates

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. Novartis AG, with which CBMG signed an agreement in October 2018 to manufacture and supply CD19 CAR T-cell therapy product Kymriah (tisagenlecleucel) in China, is also an investor.

Opportunities, challenges as regenerative medicine explodes

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. As of June 30, more than 2,600 clinical trials were underway worldwide, according to the Alliance for Regenerative Medicine, with 956 unique regenerative medicine therapies in development, 136 of which are in phase III. Within five years, those numbers are expected to triple.

Roche-Regeneron cocktail reduces viral load in hospitalized COVID-19 patients

New data on the COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), already used to treat non-hospitalized patients, could potentially support expanding its use to certain recently hospitalized patients with the disease. Phase II/III results presented by Roche Holding AG at the Infectious Disease Society of America's IDWeek 2021 showed the cocktail, also known as REGEN-COV, met the study's primary endpoint of significantly reducing viral load in seronegative patients hospitalized with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline. The product is jointly developed by Roche and Regeneron Pharmaceuticals Inc.

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