Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Genentech, Intercept, Molecular Templates, Pfizer, Seagen.
Acadia Pharmaceuticals Inc. will make available by the end of this month Daybue (trofinetide), a synthetic analogue of the amino‐terminal tripeptide of IGF-1 for Rett syndrome (RS), which was greenlighted by the U.S. FDA March 10 and remains in the works for fragile X syndrome as well as undisclosed other indications.
Securities litigation is a fact of life in the U.S., but the volume of these cases is down somewhat from the four years between 2017 and 2020, during which an average of roughly 380 such cases were filed each year. The life science industries typically account for approximately one in four of these cases, which were down to less than 200 last year, but attorneys with Dechert LLP told BioWorld that the falling numbers do not suggest that this is a time to take anything for granted where securities litigation is concerned.
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
A California man agreed to settle insider trading charges related to Tokyo-based Astellas Pharma Inc.’s buyout offer of San Francisco-based Audentes Therapeutics Inc. in December 2019 for $3 billion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livanova, Tyber.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenue, Biocryst, Estrella, Janssen, Novo Nordisk, Scisparc, Soligenix, Vertex.
While the U.S. is in an IPO drought, going public remains the only lifeline for many small life sciences companies facing a decade of development, R&D costs of $1 billion or more, and a hefty risk of failure, Susan Washer, former CEO of Applied Genetic Technologies Corp., testified in a March 9 hearing before the House Subcommittee on Capital Markets.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
RSS
