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BioWorld - Wednesday, May 31, 2023
Home » Topics » North America » U.S.

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Fraud blocks under magnifying glass

US surgeon agrees to pay $43M for unperformed vascular procedures

May 30, 2023
By Mark McCarty
No Comments
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
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FDA wraps up morcellation containment bag guidance, containment use still down

May 30, 2023
By Mark McCarty
No Comments
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
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3D illustration of transparent human torso with close up of spinal cord

Locate Bio receives breakthrough nod for Ldgraft spine fusion system

May 25, 2023
By Nuala Moran
No Comments
The U.S. FDA has awarded Locate Bio Ltd. a breakthrough device designation for its Ldgraft spine fusion product for the treatment of degenerative disk disease, paving the way to the first in human study later this year.
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Boston Scientific abandons $230M purchase of M.I. Tech due to pressure from regulators

May 25, 2023
By Mark McCarty
No Comments
Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national regulatory authorities as a factor in scotching the proposed acquisition, the second time in recent weeks that government agencies have grounded mergers and acquisitions in the med-tech space.
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Oral COVID-19 antiviral Paxlovid wins full FDA approval

May 25, 2023
No Comments
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
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US Federal Circuit sides with Teleflex in catheter patent scrum with Medtronic

May 24, 2023
By Mark McCarty
No Comments
Patent disputes over medical technology exert a significant influence on a company’s fortunes in the marketplace, and a recent decision by the U.S. Court of Appeals for the Federal Circuit reinforces yet again the importance of patent protection for device manufacturers. In a decision filed May 24, the Federal Circuit decreed that patents for catheters held by Teleflex Innovations were not rendered ineligible by what Dublin-based Medtronic plc had asserted was prior art, thus dealing Medtronic a blow in its efforts to have the five Teleflex patents in question rendered null.
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Sequana---Alfapump,-Cathether,-charger.jpg

Sequana considers listing in the US as it looks for growth for Alfapump

May 24, 2023
By Shani Alexander
No Comments
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
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US CMS flexes muscle in proposing Medicaid Rx pricing tools

May 24, 2023
By Mari Serebrov
No Comments
The U.S. Centers for Medicare & Medicaid Services (CMS) is flexing its new authority in a proposed rule intended to clamp down on drug prices by providing more transparency in the Medicaid program.
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Xacduro

Entasis’ bacterial infection drug receives FDA approval

May 24, 2023
By Lee Landenberger
No Comments
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.
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Congress, states staging Act 2 of US Rx pricing reforms

May 23, 2023
By Mari Serebrov
No Comments
When it comes to cutting health care costs in the U.S., last year’s Inflation Reduction Act, with its inflationary rebates and direct Medicare negotiations, was just Act 1. Now lawmakers, in both the House and Senate, are feverishly working on bipartisan scripts for Act 2 that go beyond biopharma’s role in drug prices to taking on pricing issues across the health care sector.
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