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Product recall concept image

J&J’s Medos withdrawing neurovascular guide catheters

April 8, 2024
By Mark McCarty
The U.S. FDA announced a class I recall of single-use neurovascular guide catheters made by Medos International Sarl SA of Neuchatel, Switzerland, because of fractures in the device’s distal catheter shaft. The FDA stated that the issue, seen in the company’s Cerebase DA line of guide sheaths, has led Medos to recommend that customers quarantine any of the affected devices, although a root cause has not yet been identified.
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Gavel and FTC logo

USTR’s Tai sees state champions as anticompetitive policy instruments

April 8, 2024
By Mark McCarty
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. 
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spirair septalign

It’s Spirair by a nose as Septalign gains FDA clearance

April 8, 2024
By Annette Boyle
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.
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Former Medivation official charged with insider trading

April 8, 2024
By Mari Serebrov
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.
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FDA widens Abecma label in MM for BMS, 2seventy

April 5, 2024
By Randy Osborne
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.
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CMS rule gives faster access to Part D biosimilars

April 5, 2024
By Mari Serebrov
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.
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Industry seeks clarity on EU’s joint clinical assessment plan

April 5, 2024
By Nuala Moran
With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
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FDA sign

US FDA, Renovo at loggerheads over added sterilization inventory

April 5, 2024
By Mark McCarty
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.
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Amylyx pulling ALS drug Relyvrio from US, Canadian markets

April 4, 2024
By Jennifer Boggs
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.
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Staphylococcus aureus

US FDA approves antibiotic Zevtera, Basilea seeks US partner

April 4, 2024
By Karen Carey
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.
Read More
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