The negative ruling from the FDA's expert adviser meeting for Eli Lilly and Innovent Biologics' PD-1 application has broad implications for Chinese biopharmas eyeing the U.S. market and future PD-1/L1 programs. Novartis India plans to cut 400 jobs after a sales pact with Dr. Reddy's. Moderna will build four new commercial subsidiaries in Asia. And more.
By taking a harsh stance, the FDA is making an example of Eli Lilly and Innovent Biologics’ PD-1 application for its trial design, execution and regulatory communication. From here on, trial diversity could be a major hurdle for Chinese biopharmas’ expansion into the U.S., SVB Leerink analyst Daina Graybosch, Ph.D., said. And the negative review is raising questions about other PD-1/L1 applications in the pipeline.
Novartis India plans to cut 400 jobs after forming a sales and distribution pact with Dr. Reddy’s Laboratories for certain established meds. The deal aims to extend the reach of healthcare professionals through an expanded field force, Novartis said. The Swiss pharma says it currently employs over 10,000 full-time staffers in India.
Moderna plans to open four new subsidiaries in Hong Kong, Malaysia, Singapore and Taiwan to expand its commercial network. The new branches will add to Moderna’s existing Asia-Pacific offices in South Korea, Japan and Australia. For Hong Kong, Moderna will hire “a dozen employees across a range of functions,” a company spokesperson said, and it will “take a similar approach” for the other new branches.
The FDA has put a clinical hold on a phase 1 trial for Legend Biotech’s early CAR-T program called LB1901. The company had already voluntarily paused the trial after the first patient dosed experienced low CD4+ T-cell counts.
Lenvima’s addition to Merck’s Keytruda failed to extend patients’ lives over Keytruda alone in certain patients with newly diagnosed advanced urothelial carcinoma in the phase 3 LEAP-011 trial. Merck’s attention for Keytruda in bladder cancer now focuses on a closely watched combination with Seagen and Astellas’ Padcev, with a readout from a key phase 1b/2 trial expected later this year.
As Innovent Biologics saw its Eli Lilly-partnered PD-1 being picked apart by the FDA, the Chinese biotech celebrated a pair of local phase 3 wins for its PCSK9 inhibitor. The company now plans to file the cholesterol-lowering candidate, dubbed IBI306, for its home market, targeting Amgen’s Repatha and Sanofi’s Praluent.
Japanese electronics giant Casio has received FDA clearance for a scope and camera system designed to help dermatologists capture high-quality photos of patients’ skin for closer observation. The company’s last medtech OK in the U.S. dated back to 1991 for the BP-100 blood pressure reading watch.
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