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BioWorld - Saturday, May 16, 2026
Home » Topics » North America » U.S.

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JAMA OpEd

Too much at stake for dismissed ACIP members to go quietly

June 17, 2025
By Mari Serebrov
No Comments
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are not going gently into the night. Instead, they’re raging against what could be the dying of the light. The 17 raised their collective voices in a June 16 JAMA opinion piece to decry what’s at stake with Health and Human Services Secretary Robert Kennedy’s efforts, in his words, to “reestablish public confidence in vaccine science” by cleansing ACIP of what he claimed were conflicts due to members’ financial ties to industry.
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Gene editing illustration

In a $1.3B deal, Lilly buys gene editor Verve

June 17, 2025
By Lee Landenberger
No Comments
With plenty of GLP-1 money to spend, Eli Lilly and Co. is buying Verve Therapeutics Inc. and its gene-editing program for about $1.3 billion. Two of Verve’s one-time treatments are in the clinic. Lead candidate VERVE-102, a gene-editing treatment targeting PCSK9, is in a phase Ib study to reduce cholesterol levels.
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Andembry

New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 17, 2025
By Karen Carey and Tamra Sami
No Comments
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
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Telomeres and DNA illustration

23andme founder-led group outbids Regeneron for company

June 16, 2025
By Annette Boyle
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
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U.S. flag on columned building

Advamed presses CMS to require MA plans to honor NTAP program

June 16, 2025
By Mark McCarty
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
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Federal judge reinstates funding for NIH DEI grants

June 16, 2025
No Comments
Calling it “incredible news,” Massachusetts Attorney General Andrea Joy Campbell reported June 16 that U.S. District Judge William Young ordered the Trump administration to restore funding for NIH research grants focusing on gender and diversity, equity and inclusion (DEI).
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For $795M, Sage is added to Supernus’ CNS quiver

June 16, 2025
By Lee Landenberger
No Comments
Supernus Pharmaceuticals Inc. is buying Sage Therapeutics Inc. for about $795 million. The deal brings Supernus, already firmly in the CNS market, the only U.S. FDA-approved oral treatment for postpartum depression. Supernus CEO Jack Khattar said he believes sales will support the acquisition, but some analysts had their doubts.
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omniasecure defib lead

FDA approves Medtronic Omniasecure defib lead

June 13, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
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Celldex’s urticaria candidate impresses in post-treatment findings

June 13, 2025
By Jennifer Boggs
No Comments
Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
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Boston Scientific Farapulse PFS system

What's the secret behind Boston Sci's successful product launches?

June 12, 2025
By Annette Boyle
Boston Scientific Corp.’s Farapulse pulsed field ablation system racked up more than $1 billion in revenue in its first year; its Watchman left atrial appendage occluder holds more than 90% of the market. How does the company choose and position its products for such astonishing success?
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