Indianapolis-based Eli Lilly and Co. agreed to acquire Point Biopharma Global Inc. for $12.50 per share in cash, or about $1.4 billion, in a deal that would bring the pharma company a pipeline of preclinical and clinical radioligand therapies for cancer. The purchase price is an 87% premium to Point’s closing stock price on Oct. 2, and a 68% premium to the 30-day volume-weighted average price. Shares (NASDAQ:PNT) of Point, also of Indianapolis, rose 84.9%, or $5.67, to close at $12.36 on Oct. 3. Read More
The ability of obesity medications to impact co-morbidities, reducing the symptoms and costs associated with down-the-road disease, has attracted significant attention throughout the biopharma industry. Read More
As pricing negotiations for Biogen Inc./Eisai Co. Ltd.’s newly approved Leqembi (lecanemab) for Alzheimer’s disease get underway at Japan’s Central Social Insurance Medical Council (Chuikyo), industry watchers see opportunity for potential drug price reform. Read More
For the second time in two weeks, the extent of regulatory flexibility will be at the heart of a U.S. FDA advisory committee meeting. The Oct. 4 meeting of the Oncologic Drugs Advisory Committee (ODAC) comes exactly a week after the Cellular, Tissue and Gene Therapies Advisory Committee voted overwhelmingly that the evidence presented for Brainstorm Cell Therapeutics Inc.’s amyotrophic lateral sclerosis drug, Nurown (debamestrocel), didn’t meet the agency’s flexibility standard. If the FDA’s briefing document for the ODAC meeting is anything to go by, the outcome for US Worldmeds LLC’s eflornithine, also known as DFMO, could be more positive, even though once again the agency is asking if the evidence from a single trial, along with supportive data, is sufficient. Read More
The Chinese government has invested $2.6 billion into building up the traditional Chinese medicine infrastructure and is actively exploring new models to integrate Chinese and Western medicine. Read More
Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Ascendis, Caliway, Cassava, Horizon, Immix, Mirum, Moleculin, Nexcella, Novartis, PDS, Pharmnovo, Pneumagen, Trevena. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aligos, Alvotech, Astrazeneca, Kashiv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANI, Avenge, Basilea, Biogen, Cabaletta, Eli Lilly, Hoth, Pharmazz, Rocket. Read More
