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BioWorld - Tuesday, June 30, 2026
Home » Topics » North America » U.S.

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Meeting illustration

Adcoms off to sluggish start with ODAC meeting on Astrazeneca drugs

April 28, 2026
By Mari Serebrov
No Comments
After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 30 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic hormone-sensitive prostate cancer that’s phosphatase and tensin homolog deficient.
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Eli Lilly logo atop Lilly Biotechnology Center campus in San Diego, Calif.

Lilly buying Ajax for up to $2.3B for next-gen JAK assets

April 27, 2026
By Karen Carey
No Comments
Eli Lilly and Co. is acquiring Ajax Therapeutics Inc. for up to $2.3 billion in cash, gaining access to next-generation JAK inhibitors for patients with myeloproliferative neoplasms.
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U.S. Capitol building

US legislative reforms needed to make biosimilars competitive

April 27, 2026
By Mari Serebrov
No Comments
Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.
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Three red darts on target

Sun Pharma to acquire Merck spinoff Organon for $11.75B

April 27, 2026
By Marian (YoonJee) Chu
No Comments
Sun Pharmaceuticals Industries Ltd. will pay $11.75 billion cash to acquire Organon & Co. The transaction is expected to close in early 2027. The addition of Organon’s women’s health products, legacy drug brands and biosimilars are expected to boost Mumbai, India-based Sun’s global reach. The all-cash buy is also expected to relieve Jersey City, N.J.-based Organon of an $8.6 billion debt pile, accumulated after its debt-laden 2021 spinout from Merck & Co. Inc.
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Atrial fibrillation illustration
Heart Rhythm 2026

Med-tech companies highlight PFA data as competition intensifies

April 27, 2026
By Shani Alexander
No Comments
New data on pulsed field ablation (PFA) presented at Heart Rhythm 2026 in Chicago over the weekend continue to show the benefits and superiority of the technologies in treating patients with atrial fibrillation. The PFA landscape is fast-evolving and med-tech players are jostling for market share with ever-differentiated platforms looking to attract electrophysiologists.
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Illustration of cancer in the bile ducts

S-OS? Compass phase II/III biliary data mixed; ahoy, FDA

April 27, 2026
By Randy Osborne
No Comments
Having already hit the primary endpoint of overall response rate in the phase II/III Companion-002 study testing the bispecific antibody tovecimig in biliary tract cancer, Compass Therapeutics Inc. rolled out new data from the same experiment and plans to meet with the U.S. FDA to discuss a BLA. Shares of the Boston-based firm (NASDAQ:CMPX) closed April 27 at $1.79, down about 64%, or $3.23, as Wall Street sifted the results.
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Male hair loss

MANE event: Veradermics beats expectations in pattern hair loss trial

April 27, 2026
By Jennifer Boggs
No Comments
Shares of Veradermics Inc. spiked as the first top-line readout from its registrational program for VDPHL-01 showed the oral, extended-release version of minoxidil surpassed expectations in men with mild to moderate pattern hair loss, setting up commercial aspirations as a potential best-in-indication treatment option.
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Drug R&D concept image.
Newco news

Anaptysbio’s spinout First Tracks hits the slopes

April 24, 2026
By Brian Orelli
No Comments
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end 2026” goal, First Tracks Biotherapeutics Inc., the drug development arm of the company, started trading as a standalone company on Nasdaq under the ticker symbol TRAX.
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Edwards Lifesciences Sapien M3

Edwards raises 2026 guidance on strong TAVR performance

April 24, 2026
By Shani Alexander
No Comments
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.
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Epileptic brain and abnormal EEG wave discharges

Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

April 24, 2026
By Karen Carey
No Comments
A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
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