The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion. Innovent’s CEO Michael Yu called this “the first solid step in getting Innovent's innovative portfolio into the global market.” With the ex-China rights of Tyvyt, Lilly plans to seek approval for the PD-1 drug in the U.S. and other markets.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion.
Since more than 40% of U.S. coronavirus deaths have links to U.S. long-term care facilities, Eli Lilly and Co. is getting on the road with a clinical trial design that takes researchers directly to outbreaks.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.
HONG KONG – China’s Shanghai Junshi Biosciences Co. Ltd. has struck a deal with Merck KGaA for a clinical trial program in China to investigate the efficacy and safety of Junshi’s anti-PD-1 monoclonal antibody (MAb), Tuoyi (toripalimab) in combination with Merck’s Erbitux (cetuximab) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck (SCCHN).
