Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laminate Medical Tecnologies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Affamed, Akebia, Altrubio, Biostem, Cel-Sci, Chrysalis, Defender, Ideaya, Mythic, Phathom, Sandoz, Sanofi, Veru.
As biosimilar development expands beyond monoclonal antibodies to more complex biologics, the flexibility built into regulatory paths across the world will become more essential. Rather than making wholesale changes to those pathways, regulators need to follow the science in exercising the flexibility they already have, Leah Christl, executive director of global biosimilars regulatory affairs and R&D policy at Amgen Inc., told BioWorld. In doing so, “we do need to look forward to what might be coming down the pipeline,” in addition to looking backwards at what types of biosimilars have already been approved, she said.
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Alvotech, Appili, Ardelyx, Biogen, Biora, Cara, Coherus, Daewoong, Eisai, Genmab, Nymox, Pfizer, Sanofi, Shuttle, Takeda, Theratechnologies, Tris.
Femasys Inc. received U.S. FDA 510(k) clearance for Femaseed, an infertility treatment that delivers sperm directly to the fallopian tubes. Less invasive and more straightforward than in vitro fertilization, the procedure offers what the company said is a new and more affordable alternative to family building for couples encountering fertility issues.
Patent challenges for radiotherapy equipment might not make the splash that in vitro diagnostic patents have, but Elekta AB and Zap Surgical Inc., have been locked in a dispute over an Elekta patent for the past four years.
The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abyrx, Femasys, Profound Medical, Profound Medical, Saluda Medical.
How flexible should the U.S. FDA evidentiary standards be for a therapy addressing a significant unmet need in a disease such as amyotrophic lateral sclerosis (ALS)? That’s the question the agency’s Cellular, Tissue and Gene Therapies Advisory Committee will ponder Sept. 27 as it looks at the data for Brainstorm Cell Therapuetics Inc.’s Nurown (debamestrocel), a mesenchymal stromal cell therapy targeting ALS. Nurown is going into the adcom with a bit of a checkered history that includes a refuse-to-file letter and a single phase III trial that failed to demonstrate efficacy for the primary endpoint and all key secondary efficacy endpoints, according to the FDA briefing document.
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