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Drug vials

Industry could feel fallout of Pfizer vaccine scrutiny

July 3, 2025
By Mari Serebrov
No Comments
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
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Fraud blocks under magnifying glass

New US working group to step up FCA enforcement

July 3, 2025
By Mari Serebrov
No Comments
The U.S. Health and Human Services and the Justice Departments are bringing more resources to their crack down on False Claims Act (FCA) violations involving drugs, medical devices and Medicare fraud.
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Xray showing lung cancer on tablet

FDA approves Dizal’s sunvozertinib for metastatic non-small-cell lung cancer

July 3, 2025
By Tamra Sami
No Comments
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
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U.S. Capitol building, Washington D.C.

House passes H.R. 1, restoring R&D tax cuts

July 3, 2025
By Mark McCarty
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
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AI-generated digital horse illustration

MDCG guidance document resurrects issue of standards for AI

July 2, 2025
The Medical Device Coordination Group (MDCG) posted a guidance document tackling the interaction between the Artificial Intelligence Act and the twin EU regulations for devices and diagnostics, but the lack of standards for AI development promises to impede efforts to bring these AI algorithms to the European market.
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Medtronic Vitalflow ECMO

Medtronic receives CE mark for its Vitalflow ECMO system

July 2, 2025
By Shani Alexander
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
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CMS logo and website

OIG presses CMS to act on overpayments related to global episodes

July 2, 2025
By Mark McCarty
The U.S. Office of Inspector General issued a report stating the Medicare program often pays for physician services that are not performed post-surgery, but the Centers for Medicare & Medicaid Services responded it is in no position to immediately begin tracking all excess payments under these global codes.
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Multiple myeloma illustration

Regeneron wins FDA nod for BCMA bispecific Lynozyfic

July 2, 2025
By Jennifer Boggs
No Comments

It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.


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Drug vials

Industry could feel fallout of Pfizer vaccine scrutiny

July 2, 2025
By Mari Serebrov
No Comments
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
Read More
CMS logo and website

CMS eyes competitive bidding for CGMs, insulin pumps

July 1, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
Read More
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