The Trump administration is reportedly weighing an executive order to limit drug licensing deals with Chinese biotechs. Daiichi Sankyo and Merck are angling for an FDA accelerated approval for their B7-H3 antibody-drug conjugate. Sun Pharma's beleaguered Halol plant in India has been slapped with an FDA import ban. And more.
1. Trump admin mulls 'severe restrictions' on US pharmas licensing Chinese meds: NYT
The Trump administration is considering a draft executive order to restrict licensing deals centered on drugs from Chinese biotechs, The New York Times reports. Large pharmas are lobbying against such a measure, whereas some biotech investors, such as Peter Thiel, are supporting the proposed crackdown, according to the report. A White House spokesman told the newspaper that the administration was not “actively considering” the draft.
2. Daiichi-Merck's advanced lung cancer ADC sees 48% response rate in registrational trial
Daiichi Sankyo and Merck are eyeing an FDA accelerated approval for their B7-H3 antibody-drug conjugate, ifinatamab deruxtecan, or I-DXd. In the primary analysis of a phase 2 trial, the drug led to an objective response rate of 48.2% among 137 patients with previously treated small cell lung cancer. The median duration of response was 5.3 months.
3. Sun's Gujarat facility put on FDA import alert for persistent production shortfalls
Sun Pharma’s manufacturing facility in Gujarat, India, has been put on the FDA’s import alert list, which bars shipments from the site into the U.S. except under certain circumstances. The import ban represents the latest of continued issues at the Halol plant. Following a June inspection, the FDA issued a 19-page, eight-observation rebuke, detailing some repeat problems flagged in an FDA warning letter from 2022.
Samsung Biologics has signed a multiyear manufacturing contract with an unnamed U.S.-based pharmaceutical company. The deal, running through the end of 2029, is worth 1.8 trillion Korean won (about $1.3 billion), making it the second-biggest that the Korean CDMO has inked since its founding in 2011.
5. Lundbeck, in major resource reallocation, bows out of 27 markets and lays off 602 staffers
Lundbeck is closing its commercial operations and transitioning to a partnership model in 27 markets, to be divided among the Swixx Group, Zuellig Pharma and NewBridge Pharmaceuticals, by Dec. 1. The Danish company’s businesses in Indonesia, Malaysia, the Philippines and Singapore will go to Zuellig.
6. Takeda, Alkermes lift lid on data for rival narcolepsy hopefuls as race to market heats up
The majority of narcolepsy patients who were treated with Takeda’s oveporexton at the twice-daily 2-mg dose achieved wakefulness as measured by the Maintenance of Wakefulness Test, according to detailed results from the FirstLight and RadiantLight phase 3 trials. As Takeda prepares regulatory filings, the company is aiming for $2 billion to $3 billion in peak sales for the orexin receptor 2 agonist in narcolepsy type 1.
7. Takeda poaches Lilly’s Rhonda Pacheco as new US chief to succeed CEO-to-be Julie Kim (release)
As Julie Kim is slated to become Takeda’s next CEO, the Japanese pharma has named Rhonda Pacheco, most recently VP of U.S. cardiometabolic health at Eli Lilly, to succeed Kim as the company’s U.S. head, effective Sept. 29. Pacheco is credited for several successful product launches, including Lilly’s GLP-1 portfolio.
Other News of Note:
9. BioNTech's HER2 ADC beats Roche's Kadcyla in phase 3 breast cancer trial
10. Junshi heralds phase 3 psoriasis win for IL-17 drug, prepares push to Chinese regulators
11. China to include HPV vaccines in national immunization program for schoolgirls (Yicai)
12. API maker Hikal hit with FDA warning letter after repeat contamination complaints
13. Astellas attacks menopause stigma with new workplace inclusivity program