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Toy bulldozer moving FDA letter blocks

FDA continues offensive against bogus device test results

May 28, 2025
By Mark McCarty
The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data.
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USTR begins search for biopharma R&D ‘freeloaders’

May 28, 2025
No Comments
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
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Gavel with whistle

DOJ makes arrests for COVID fraud in excess of $227M

May 27, 2025
By Mark McCarty
The U.S. Department of Justice arrested two men in connection with fraudulently billing the Medicare program for COVID-19 tests, some of which were billed for deceased beneficiaries. The case is notable for its use of foreign nationals recruited to set up non-existent labs to file the claims, seeming to signal a new front in efforts to corral Medicare fraud in the U.S.
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Kennedy welcomes end of COVID-19 vaccines for healthy kids

May 27, 2025
By Mari Serebrov
No Comments
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
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Samsung Biologics plant

Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

May 27, 2025
By Marian (YoonJee) Chu
No Comments
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
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Longtime life sciences director hit with insider trading

May 27, 2025
By Mari Serebrov
No Comments
A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal.
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Phraxis Endoforce

Phraxis Endoforce receives FDA approval for anastomosis

May 23, 2025
By Annette Boyle
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
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U.S. Capitol building

PTO director candidate Squires appears at Senate Judiciary

May 23, 2025
By Mark McCarty
The Trump administration nominated John Squires of the firm of Dilworth Paxson to take the post of director of the Patent and Trademark Office, but the appointment faces a few hurdles.
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Antibody-drug conjugate

Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

May 23, 2025
By Nuala Moran
No Comments
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
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In search of lower prices, FDA enhances Rx import program

May 23, 2025
By Mari Serebrov
No Comments
It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.
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