Eli Lilly and Innovent Biologics' non-small cell lung cancer application for PD-1 inhibitor Tyvyt looks like a dud after harsh FDA criticism and a thumbs-down from an advisory committee. Biogen and Eisai have filed their formal complaint against a limited Medicare coverage proposal for Alzheimer's disease drug Aduhelm. The U.S. Government Accountability Office made several recommendations for the FDA to revamp its foreign inspections, including conducting unannounced check-ups. And more.
1. Thumbs-down on Lilly, Innovent China trial for lung cancer drug Tyvyt, says FDA AdComm
An FDA oncology advisory committee voted 14-1 against approving Eli Lilly and Innovent Biologics’ PD-1 inhibitor Tyvyt in newly diagnosed nonsquamous non-small cell lung cancer. The expert panel largely agreed with the FDA that the phase 3 study used for the application, conducted solely in China, doesn’t reflect the U.S. population and that the trial’s chemotherapy comparator arm is outdated as Merck’s PD-1 drug Keytruda has become the standard of care in the U.S. The thumbs-down came despite Lilly offering about 40% discount for the drug compared to existing PD-1 options.
2. Biogen, Eisai strike back against CMS' stifling Aduhelm coverage proposal
Biogen and Eisai submitted formal comments protesting The Centers for Medicare and Medicaid Services’ proposed policy of limiting coverage of the pair’s Alzheimer’s disease drug Aduhelm to patients in approved clinical trials. The partners argue the requirement would significantly limit and delay treatment for patients and would be unfair compared with coverage of other drugs under the FDA’s accelerated approval pathway.
The FDA should develop a plan to recruit investigators to specifically conduct manufacturing inspections overseas, the U.S. Government Accountability Office said in a new report. The drug regulator should also start doing unannounced foreign inspections, GAO said. The agency currently does foreign inspections preannounced but often run surprise check-ups stateside.
4. Hunting for cutting-edge biotech, Fujifilm sets up early-stage VC fund
Fujifilm launched a new life sciences venture capital fund with an initial investment of 7 billion Japanese yen ($60 million). The new group is also taking in the Japanese firm’s previous life science investment portfolio, which includes regenerative medicine, cell therapies and early drug discovery projects.
5. Celltrion races inhaled COVID-19 antibody therapy into phase 3 to counter omicron
Celltrion is moving its inhaled COVID-19 antibody combo therapy into a proposed global trial of 2,200 patients with mild to moderate COVID-19. The regimen includes a nebulized formulation of regdanvimab, sold in some territories in an infused form as Regkirona, and an investigational molecule coded CT-P63.
6. Takeda taps a doctor turned patient—and spread-the-word artist—for rare disease awareness campaign
Takeda’s U.K. unit has tapped a rheumatologist-turned-patient for an awareness campaign for vasculitis, a rare autoimmune disease that causes inflammation of the blood vessels. The first stage of the initiative features a short video of a drawing by the patient, Shanali Perera, to illustrate the initial experience of noticing symptoms and diagnosis. The campaign’s later work will depict life during and after diagnosis.
7. Takeda joins Novartis and Merck in $45M funding for Koneksa Health
Takeda Ventures chipped in a $45 million series C round at Koneksa Health, which bills itself as a digital biomarker company. The company's platform is designed to analyze clinical trial data from wearables and sensors to help with trial recruitment, improve experience for patients and empower sponsors and research organizations.
CANbridge is moving an anti-C5 drug forward after seeing early data from 31 healthy volunteers. The Chinese company is now launching a Chinese phase 1b/2 clinical trial for the drug, CAN106, in paroxysmal nocturnal hemoglobinuria, targeting AstraZeneca's Soliris and Ultomiris.