In a deal that could bring Arvinas Inc. a potential $2.4 billion, the company will collaborate with Pfizer Inc. to develop and commercialize an oral estrogen receptor protein degrader. In addition to a potential $400 million in approval milestones and a possible $1 billion in commercial milestones, Arvinas will be paid $650 million up front by Pfizer, which will also make an equity investment of $350 million in Arvinas while receiving about 3.5 million newly issued Arvinas common stock shares. With the deal, Pfizer will have a 7% equity share in Arvinas. The two plan to equally divide development and commercialization costs as well as any profits. Read More
Differences between Seres Therapeutics Inc.’s next-generation microbiome therapy and SER-287 were highlighted in the wake of the phase IIb failure with the latter in the study called Eco-Reset, which missed its primary endpoint of improving clinical remission rates in ulcerative colitis (UC) compared to placebo. Read More
LONDON – Hemab ApS has closed a $55 million series A to take forward treatments for bleeding and thrombosis disorders based on antibodies in-licensed from Novo Nordisk A/S, where the newco’s founder, Johan Henrik Faber, previously led hemophilia drug research. Read More
DUBLIN – Anocca AB raised $47 million in a series B round to advance its T-cell-based immunotherapies expressing recombinant T-cell receptors (TCRs) toward clinical trials in cancer and to build out its manufacturing capacity at its base in Södertälje, Sweden. Read More
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision. Read More
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection. Read More
The biotech industry in Asia is a promising market, but it still has a long way to go to narrow the gap between Asian and Western markets, according to speakers on day two of the BIO Asia-Taiwan Conference 2021. Read More
The U.S. Federal Trade Commission (FTC) had previously reported it would more tightly scrutinize mergers and acquisitions with an eye toward the impact on competition, and voted July 21 to expand its authority to review these activities. The agency also voted to eliminate restrictions by original equipment manufacturers (OEMs) on servicing of their devices, thus putting both drug and device makers on alert that much more rigorous FTC enforcement has arrived. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aprea, Biomarin, Dicerna, Eureka, Immunomolecular, Lumos, Scilex, Sorrento, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Ascentage, Astellas, Bluebird, Direct, Genentech, Inozyme, Magenta, Merck & Co., Organicell, Rarestone, Viracta. Read More
