Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Attgeno, Cellenkos, Eli Lilly, Incyte, Innovent, Moderna, Nammi, Outlook, Stealth, Tremeau.
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
Everest Medicines Ltd. has picked up its first marketing approval in China for Trodelvy (sacituzumab govitecan), a medicine licensed from Gilead Sciences Inc. It was approved to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The European Commission and the U.S. Department of Health and Human Services (HHS) recently signed an arrangement to strengthen their cooperation on preparedness and response to public health threats.
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week.
With Alnylam Pharmaceuticals Inc.’s FDA clearance for Amvuttra (vutrisiran) in the rearview mirror, investors are looking ahead to potentially label-widening phase III data related to another, already approved drug: Onpattro (patisiran).
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