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BioWorld - Thursday, February 12, 2026
Home » Topics » U.S., BioWorld

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BIO2025: John Crowley and Martin Makary

BIO 2025: Makary lays out FDA’s path, launches pilot review program

June 18, 2025
By Karen Carey
No Comments
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
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Nextcure stock drops near 30% on $745M ADC deal with Simcere

June 17, 2025
By Marian (YoonJee) Chu
No Comments
Shares of Nextcure Inc. (NASDAQ:NXTC) dropped 26.27% on news of a potential $745 million partnership with Simcere Zaiming for Simcere’s cadherin-6 antibody-drug conjugate (ADC) candidate. Shares ended at 50 cents apiece June 16.
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Dyne vHOT in DM1 but shares cool on endpoint switch

June 17, 2025
By Randy Osborne
No Comments
The revised trial protocol that means a delay in filing for U.S. approval of DYNE-101 to treat myotonic dystrophy type 1 (DM1) dented shares of Dyne Therapeutics Inc. (NASDAQ:DYN), which closed June 17 at $10.86, down $2.96, or 21%.
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BIO 2025: Bridging the gap with a ‘molecule-to-medicine expressway’

June 17, 2025
By Karen Carey
No Comments
For years, the biopharma industry has spent increasing amounts of money on R&D without improving success rates, leaving many executives searching for new, more predictable drug development paths.
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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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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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