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).
LONDON – Evox Therapeutics Ltd. sealed a $1.2 billion collaboration with Eli Lilly and Co. to apply its exosome technology to the doubly difficult task of systemically delivering RNA interference and antisense oligonucleotide drugs, to reach central nervous system targets.
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).
Eli Lilly and Co. said June 1 the first patients have been dosed in a phase I test of LY-CoV555, a potential antibody treatment for COVID-19, with results expected by June 30. Should it prove safe, the candidate could quickly move into a phase II trial to assess its efficacy, Ajay Nirula, vice president of immunology at Lilly, told BioWorld.
Unpredictable and unaffordable copays for insulin could be a thing of the past for millions of people enrolled in certain Medicare Part D prescription drug plans.
