The pharma industry is pushing back at the government's call to "onshore" manufacturing for the U.S. market. Takeda decided to stop development of Shire's SHP647, a drug the European Commission had asked the company to sell to win antitrust approval for the merger. China's Legend Biotech is now aiming to raise $350 million in its U.S. IPO. And more.
U.S. lawmakers and the Trump administration are pushing to “onshore” drug manufacturing at the expense of major producers abroad, India and China. But the pharma industry doesn’t seem so keen about that shake-up. Its reasoning is simple: Manufacturing stateside would likely cost a lot more and would upset the balance of pharma’s global supply chain.
The European Commission is no longer requiring Takeda to offload Shire’s inflammatory bowel disease candidate SHP647 as part of the agreement to approve the merger. Once thought to be a competitor to Takeda’s own Entyvio, the drug didn't attract much interest; Takeda couldn’t find it a new owner after talking to more than 60 potential buyers. Now, the drugmaker will simply cull the med.
Chinese CAR-T specialist Legend Biotech has filed to raise $350 million for its Nasdaq IPO, according to a revised securities filing. It’s offering 18.4 million ADSs at a price of $18 to $20 apiece. At the midpoint of that range, the company would be valued at $2.6 billion.
AbbVie has licensed a portfolio of SHP2 inhibitors from Chinese biotech Jacobio Pharmaceuticals. The deal sees Jacobio take care of early clinical trials, with AbbVie covering R&D expenses. After that, the Illinois pharma will take over, and Jacobio has an option in Greater China.
A former Biogen employee surnamed Li has been officially arrested in Beijing after allegedly hiding her coronavirus symptoms during a flight from the U.S. back to China. She’s facing the charge of impairing the prevention of infectious disease, an offense that could result in prison time of less than three years or up to seven years if the court finds her actions led to serious consequences.
The FDA recently identified a likely carcinogen in samples of widely used diabetes med metformin. Now, the FDA is recommending five manufacturers pull their extended-release products, while working with drugmakers to determine whether the recalls would cause a shortage. The five firms are Apotex, Actavis, Amneal, Lupin and Marksans.
WuXi AppTec has named David Chang to lead its cell and gene therapy-focused CDMO, WuXi Advanced Therapies. Chang most recently worked as head of cell therapy global manufacturing at Celgene, leading the company’s CAR-T production efforts. Manufacturing hiccups have hit other CAR-T drugs, including Novartis’ Kymirah, and the FDA recently refused to review an application of Bristol Myers Squibb’s Celgene-inherited ide-cel based on slim manufacturing details.
China’s Genor Biopharma has collected $160 million in a series B round led by Hillhouse Capital. Other investors, including Temasek, also chipped in. The company is developing antibodies for cancers and autoimmune diseases like rheumatoid arthritis. It counts more than 10 clinical-stage assets.
Daiichi Sankyo has signed on Syneos Health to help its clinical work on three antibody-drug conjugates: Enhertu, DS-1062 and U3-1402. DS-1062, a TROP2-targerting drug, has completed a phase 1 in non-small cell lung cancer (NSCLC), while U3-1402 targets HER3, with data in EGFR-mutated, TKI-resistant NSCLC presented last year.