Merck KGaA is in-licensing a PARP1 inhibitor from Hengrui. Novartis said an ex-employee who recently jumped to Takeda took sensitive files. The FDA has approved Coherus and Junshi's China-made PD-1 inhibitor toripalimab. And more.
Merck KGaA is paying 160 million euros for ex-China rights to Jiangsu Hengrui Pharmaceuticals’ PARP1 inhibitor, HRS-1167, with 1.6 billion euros lined up as potential milestones. Merck’s betting that a PARP1-specific inhibitor might avoid some hematologic toxicity that has limited the dosing and combinability of existing PARP1/2 inhibitors such as Merck & Co. and AstraZeneca’s Lynparza.
Novartis believes a former employee jumped ship to Takeda this year after transferring around 10,000 files to his personal email. The staffer, Khaled Shams Eldin, was previously operations lead for cell and gene therapy at Novartis’ Egypt branch. He joined Takeda Egypt as divestment and contract manufacturing implementation lead. Novartis is seeking a subpoena to look at certain Takeda documents.
After a regulatory saga, Coherus BioSciences has won the first FDA approval for a China-made PD-1 inhibitor. The company’s Junshi Biosciences-partnered toripalimab became the first FDA-approved therapy for metastatic nasopharyngeal carcinoma. Although PD-1 inhibitors are notably cheap in China, Coherus won’t adopt “heavily discounted pricing” for its drug in the U.S., CEO Denny Lanfear said.
Daiichi Sankyo has increased its revenue forecast for the current fiscal year by 100 billion Japanese yen ($660 million) to a total of 1.55 billion yen. The company cited the newly signed antibody-drug conjugate deal with Merck & Co., Enhertu’s revenue and foreign exchange for the adjustment. The Japanese pharma also plans an internal merger to absorb two manufacturing subsidiaries.
The FDA recently labeled Olympus’ corrective actions for a problem with its UHI-4 insufflation hardware a Class I recall, the agency’s most serious. The agency said it received reports of 21 malfunctions, including 10 serious injuries and one death. The reports described incidents where elevated air pressure the Olympus equipment induced within the abdomen interfered with heartbeats.