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Collection of vials

More biosimilars from China, US encroach on Amgen’s denosumab

April 9, 2024
By Marian (YoonJee) Chu
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
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Regulatory icons

ANVISA to consider other regulatory decisions for device registration

April 9, 2024
By Mark McCarty
While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.
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FDA icons and doctor

Attorney says wound dressings in ‘dire circumstances’ under FDA draft rule

April 9, 2024
By Mark McCarty
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
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U.S. Securities and Exchange Commission

Jury agrees with SEC’s ‘shadow trading’ allegations

April 8, 2024
By Mari Serebrov
A quick jury verdict that a biopharma official was guilty of insider trading validated the U.S. SEC’s broader view of what constitutes such trading and could ignite more SEC “shadow trading” investigations and allegations. Following an eight-day trial before the U.S. District Court for the Northern District of California and a little more than two hours of deliberation, a jury found April 5 that Matthew Panuwat violated national securities laws when he purchased short-term, out-of-the-money stock options in Incyte Corp. in 2016.
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FDA expands Legend, J&J’s Carvykti with ‘best-case’ label in MM

April 8, 2024
By Jennifer Boggs
Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
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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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