Biocon's biosimilar manufacturing sites were hit with several FDA Forms 483. Fosun Pharma's Shanghai Henlius Biotech is looking for a U.S. partner for its PD-1 inhibitor as the company shifts focus from biosimilars to innovative drugs. Takeda has returned two microbiome-based inflammatory bowel disease projects to Finch Therapeutics. And more.
1. FDA slaps Biocon following inspections of biosimilar production sites in India, Malaysia
Just as Biocon touted its biosimilar manufacturing capabilities in a proposed acquisition of partner Viatris’ biosimilar portfolio, the Indian company was hit with multiple Forms 483. Its two biologics plants in India got 11 observations each, and its Malaysian site received six observations. They followed preapproval inspections of a biosimilar to Roche’s Avastin and two insulins.
2. Henlius CEO scouts for US PD-1 partner amid Fosun unit's pivot to innovative drugs from biosimilars
Shanghai Henlius Biotech, a unit of Fosun Pharma, is looking for a U.S. partner for its China-approved PD-1 inhibitor serplulimab, CEO Wenjie Zhang said. The company is initially targeting small cell lung cancer, where Bristol Myers Squibb’s Opdivo and Merck’s Keytruda have chalked up failures. Zhang also believed that the expected inclusion of biologics and biosimilars in China’s volume-based procurement won’t hurt Henlius’ anchor biosimilar business too much.
3. Takeda returns 2 inflammatory bowel prospects back to Finch's nest
Takeda decided to end its inflammatory bowel disease collaboration with Finch Therapeutics, which included two preclinical microbiome-based candidates. The news came a year after Takeda decided to accelerate the transition of development responsibility for one asset, ahead of the originally planned first-in-human study. In the deal, Takeda has paid $44 million in total, including for R&D expense reimbursement.
4. AstraZeneca's Evusheld nabs its first global nod as a COVID treatment
AstraZeneca’s Evusheld nabbed its first nod as a COVID treatment thanks to a go-ahead from Japanese authorities. Before that, Evusheld has been authorized in many territories to prevent infection before exposure in people who may not launch an adequate immune response to vaccines.
5. Blanchard abseils down from Everest, walking out as CEO with immediate effect
Everest Medicines CEO Kerry Blanchard resigned shortly after the Chinese biotech handed rights to Trodelvy in China and certain other Asian markets to Gilead Sciences. Everest has “identified a finalist among a short list of CEO candidates” following “an extensive search in the past few months,” its chairman Wei Fu said.
6. After setbacks in AbbVie’s CD47 deal, I-Mab sharpens focus to 5 drugs (release)
I-Mab has decided to prioritize five assets out of 20 because “they are value drivers,” CEO Jingwu Zang told investors during the company’s second-quarter earnings call. The move comes as AbbVie capped two trials of I-Mab’s CD47 drug lemzoparlimab and revised their partnership with reduced milestone potential. The company is also looking for global partners for CD73 antibody uliledlimab and a Claudin18.2/4-1BB bispecific antibody, he said.