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Fierce Pharma Asia—Merck KGaA and Hengrui's PARP deal; Novartis and Takeda's employee dispute; toripalimab's FDA nod

2023-11-03

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上市批准抗体药物偶联物引进/卖出并购

Merck KGaA and Hengrui's PARP1 licensing deal, Novartis' request for discovery against Takeda and the FDA's first approval for a China-made PD-1 inhibitor made our news this week.

Merck KGaA is iHengruisinPARP1ARP1 inhibitor frNovartisui. Novartis said an ex-employee who recently jFDAed to Takeda took sensitive files. PD-1FDA has approved Coherus and Junshi's China-made PD-1 inhibitor toripalimab. And more.

Merck KGaAays $169M for selecPARP1 inhibitor PARP1PARP1 drug, stepHengrui cNovartis to AstraZeneca and GileadFDA Junshi PD-1 toripalimab

MerMerckaA is paying 160 million ePARP1for ex-China rights to Jiangsu HAstraZenecamaceuGilead’ 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.

Merck KGaAs claims ex-staffer jumped to Takeda with 'thousandsJiangsu Hengrui Pharmaceuticals PARP1 inhibitor PARP1 HRS-1167 Merck PARP1-specific inhibitor PARP1-specific PARP1/2 inhibitors Merck & Co.AstraZeneca Lynparza

NovNovartislieves 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.

Novartisus rejects 'heavily discounted' pricing on Loqtorzi, the first China-made PD-1 drug to win FDA nodNovartis Takeda Egypt Novartis

AftCoherusgulatory saga, Coherus BioSciences has woLoqtorzirst FDA approval for a PD-1 druge PD-1 iFDAbitor. 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.

4. Daiichi Sankyo ups revCoherus BioSciencess to massive Merck FDAlPD-1 Junshi Biosciences toripalimab FDA metastatic nasopharyngeal carcinoma PD-1 Coherus

DaiDaiichi Sankyo absorb manufacturing units in move to lMerckge ADC strength

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.

Daiichi Sankyolympus laparoscopic insufflation hardware recall to 10 injuries, one deathMerck & Co.

TheFDAA recenOlympuseled 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.