Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
A new collaboration with Dren Bio Inc. means Novartis Pharma AG has negotiated two of the biggest deals of 2024, with its parent company Novartis AG signing a third. Privately held Dren is getting $150 million up front and the chance to ultimately bring in $2.85 billion. The $150 million up-front payment includes a $25 million equity investment.
Hillevax Inc. is turning its attention to preventing moderate or severe acute gastroenteritis events (AGEs) in adults with norovirus after the phase IIb NEST-IN1 trial testing virus-like particle-based vaccine HIL-214 in infants missed its primary and secondary endpoints, news that sent shares of the company (NASDAQ:HLVX) plummeting 88% to close July 8 at $1.64, a significant drop from the IPO price of $17 two years ago.
The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Suzhou, China-headquartered Ascentage Pharma Group Corp. Ltd. has filed plans for a confidential IPO to the U.S. SEC for a potential dual listing on both the U.S. and Hong Kong stock exchanges. News of the U.S. IPO came just a few days after Ascentage drew a $75 million equity investment from Osaka, Japan-headquartered Takeda Pharmaceutical Co. Ltd. with the issuance of about 24.3 million shares at a purchase price of HK$24.09 (US$3.08) per share.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
