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BioWorld - Tuesday, May 26, 2026
Home » Topics » North America » U.S.

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A lot to (not) be desired: Jasper CSU drug batch under scrutiny

July 7, 2025
By Randy Osborne
No Comments

Jasper Therapeutics Inc.’s otherwise upbeat data with subcutaneous briquilimab was hamstrung by apparent trouble with one lot of drug used in the phase Ib/II Beacon study in chronic spontaneous urticaria. Shares of the Redwood Calif.-based firm (NASDAQ:JSPR) closed July 7 at $3.04, down $3.73, or 55%.


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Kennedy adopts two ACIP vaccine recommendations

July 3, 2025
No Comments
With no U.S. CDC director in place yet, Health and Human Services Secretary Robert Kennedy recently adopted two vaccine recommendations from the April meeting of the Advisory Committee for Immunization Practices (ACIP), making them official CDC recommendations and ensuring coverage of the vaccines for the specified populations.
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FieldForce Catheter

Field reaps $35M for ventricular PFA

July 3, 2025
By Annette Boyle
Field Medical Inc. continues to reap funding from investors for its pulsed field ablation (PFA) system with a $35 million oversubscribed series B financing round. With treatment of atrial fibrillation already upended by PFA technology, Field sees ventricular tachycardia as a fertile new territory for transformation.
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Lunit

Lunit, Microsoft to codevelop cloud-based clinical AI solutions

July 3, 2025
By Marian (YoonJee) Chu
Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
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3D heart in chest

CMS deletes two specialists to NCD final for tricuspid repair devices

July 3, 2025
By Mark McCarty
The final Medicare coverage memo for transcatheter edge-to-edge repair for tricuspid valve regurgitation largely replicates the April 2025 draft, but cardiology centers will not have to bring an electrophysiologist to the patient’s care team to be permitted to practice these devices.
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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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Zanza time trickle in ESMO hourglass: more Exelixis CRC data?

July 3, 2025
By Randy Osborne
No Comments
Exelixis Inc.’s positive phase III top-line data June 22 with zanzalintinib (zanza) in colorectal cancer had Wall Street speculating anew about the odds with the tyrosine kinase inhibitor in an important indication.
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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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