Life science companies and the Office of the U.S. Trade Representative have not always seen eye to eye on issues such as compulsory licensing, but industry might be supportive of a remark by U.S. Trade Representative Katherine Tai about companies that are provided with anticompetitive breathing by their host governments with noticeable anticompetitive effect.
Spirair Inc. won the race for the first U.S. FDA 510(k) clearance for a minimally invasive therapy for nasal septal deviation (NSD), the company said. The Septalign system features a bioabsorbable implant that enables minor cartilaginous septal deviation that can be placed in an office with local anesthesia.
“Traditional septoplasty and septorhinoplasty can require significant time away from work, with nearly 42% of patients requiring two weeks or more for recovery. With Septalign, recovery is much faster and requires little to no time away from work for recovery,” Spirair CEO Ben Bishop told BioWorld.
Insider trading goes beyond the bounds of the companies at the center of nonpublic information, the U.S. SEC reminded biopharma industry insiders Aug. 17 when it charged Matthew Panuwat, former head of business development at Medivation Inc., with insider trading ahead of the California company’s Aug. 22, 2016, announcement that it was being acquired by Pfizer Inc. in a $14 billion deal.
Mixed opinions from the U.S. FDA’s Oncology Drugs Advisory Committee last month didn’t stop the agency from green-lighting an expanded label for Abecma (idecabtagene vicleucel) to include adults with relapsed or refractory multiple myeloma (r/r MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
In finalizing its 2025 Medicare Advantage and Part D rule, the U.S. Centers for Medicare & Medicaid Services (CMS) all but did away with the coverage differences between biosimilars and interchangeables.
Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.
Paragonix Technologies Inc. expanded access to its U.S. FDA-cleared Baroguard donor lung preservation system following a successful limited release with a handful of top transplant centers. In addition to critical temperature control, the new system provides active airway management to keep donor lungs in the best condition possible.
Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market.
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
Positive updated phase II data with CAN-2409 in pancreatic cancer led shares of Candel Therapeutics Inc. (NASDAQ:CADL) to close April 4 at $6.40, up $4.72, or 281%, well above the firm’s previous 52-week high. At one point during the day, the stock had climbed to $7.65.
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.png?height=488&t=1712351692&width=650 "Paragonix Technologies Inc.’s Baroguard donor lung preservation system")
