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

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来源: FiercePharma

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 in-licensing a PARP1 inhibitorPARP1 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.

1. Merck pays $169M for selective PARP1 drug, stepping up challenge to AstraZeneca and Gilead

Merck KGaA is paying 160 million euros for ex-China rights to Jiangsu Hengrui Pharmaceuticals’ PARP1 inhibitorPARP1 inhibitor, HRS-1167, with 1.6 billion euros lined up as potential milestones. Merck’s betting that a PARP1-specific inhibitorPARP1-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.

2. Novartis claims ex-staffer jumped to Takeda with 'thousands' of sensitive files

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.

3. Coherus rejects 'heavily discounted' pricing on Loqtorzi, the first China-made PD-1 drug to win FDA nod

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.

4. Daiichi Sankyo ups revenue forecast thanks to massive Merck deal

Daiichi Sankyo to absorb manufacturing units in move to leverage 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.

5. FDA links Olympus laparoscopic insufflation hardware recall to 10 injuries, one death

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.

Other News of Note

6. Aragen to beef up biologics manufacturing, investing $30M in new site in India

7. Resolian, the CRO formerly known as Alliance, makes move into China with Denali acquisition

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