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BioWorld - Saturday, May 16, 2026
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AI-generated image of illustration of MRI of lungs with fibrosis

Tweaked pirfenidone, other strategies in the works for IPF

July 2, 2025
By Randy Osborne
No Comments
Puretech Health plc’s rollout May 20 of more phase IIb data with deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF) perked optimism for that compound – a deuterated form of p38 MAP kinase inhibitor pirfenidone – as well as others in the busy therapeutic space.
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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.
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Molecule illustration
Immune

Unnatural Products joins Argenx in a $1.5B macrocyclic deal

July 2, 2025
By Lee Landenberger
No Comments
Unnatural Products Inc. notched another collaboration by signing on with Argenx SE in a multitarget research collaboration. Unnatural Products, which is getting up-front, near-term payments and R&D funding, could end up with about $1.5 billion in milestones and options payments plus tiered royalties on net sales.
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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.
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tricuspid regurgitation

New York Valves: More options, more valves

July 1, 2025
By Annette Boyle
Aortic valve repair and replacement continue to grab attention appropriate for the number of people affected, but the heart’s other three valves are finally gaining some respect as med-tech companies and analysts recognize the size of the potential total addressable market.
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Handshake with charts, maps, data

US agencies to assemble health care fraud data fusion system

July 1, 2025
By Mark McCarty
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
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Deal handshake with coin, chart background

After axing 95% workforce, Vor bets $4B+ on Remegen’s telitacicept

July 1, 2025
By Marian (YoonJee) Chu
No Comments
Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.
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CAR T cell attacking cancer cells

China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

July 1, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
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Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
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ACIP questions remain unanswered

July 1, 2025
By Mari Serebrov
No Comments
While the first meeting of the U.S. CDC’s newly minted Advisory Committee for Immunization Practices (ACIP) is now recent history, questions about the makeup of the committee and its future direction remain unanswered.
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