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BioWorld - Saturday, April 4, 2026
Breaking News: Best of BioWorld Science: Q1Breaking News: Best of BioWorld Science: Q1
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Appointments and advancements for March 11, 2026

March 11, 2026
New hires and promotions in the biopharma and med-tech industries, including: Aeon, Butterfly, Dermata, H. Lundbeck, MBX, Odyssey, OSE, Qlaris, Sandoz, Santhera, Vect-Horus.
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Laptop, stethoscope, medical icons, health professional

ARPA-H sets sights on next-gen biosensors

March 11, 2026
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The Advanced Research Projects Agency for Health (ARPA-H) launched its Delphi program March 10 to advance the development of the next generation of wearable and ingestible biosensors that can securely report deep biological data to optimize health care.
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Laptop displaying FDA logo

FDA unifying, modernizing adverse event reporting system

March 11, 2026
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The U.S. FDA has begun moving its patchwork of adverse event (AE) reporting systems into a single, intuitive AE platform that will cover all its centers.
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Illustration of inflamed spine

China’s Qyuns moves IL-17 biologic toward first approval

March 11, 2026
By Tamra Sami
No Comments
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
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Pregnancy

Uterus transplants show how immune cells shape pregnancy outcomes

March 11, 2026
By Nuala Moran
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A study involving a small cohort of women who have received womb transplants has cast fresh light on how the immune system shapes pregnancy outcomes, opening up new avenues of research into implantation failure, preeclampsia and preterm birth.
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Screenshot of “Kill the Clipboard” app

Samsung is adding trials and EHR access to Galaxy devices

March 11, 2026
By Marian (YoonJee) Chu
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Samsung Electronics Co. Ltd. is partnering with Verily Life Sciences LLC, an Alphabet Inc. company, and B.well Connected Health to turn Samsung Galaxy phones and smart watches into the “front door” of U.S. health care.
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doctor, checklist, apple, prescription bottle and blood glucose meter illustration

Hightide wins China NDA acceptance for oral metabolic therapy

March 11, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
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Photo of magnifying glass inspecting the text FDA

FDA ‘blacklist’ in DMD? Legislator slams PTC turndown

March 11, 2026
By Randy Osborne
No Comments
The strife-marked Duchenne muscular dystrophy (DMD) space drew forth another outspoken political figure in the shape of Sen. Ron Johnson (R-Wisc.), who said he was “enraged” by the U.S. FDA’s refusal to consider PTC Therapeutics Inc.’s Translarna (ataluren) for the treatment of nonsense mutation disease.
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Senator urges renewal of access to PTC’s Translarna in DMD

March 11, 2026
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A preview of the next edition of BioWorld, March 11, 2026
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Regulatory actions for March 10, 2026

March 10, 2026
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astrazeneca, BMS, Chiesi, Claritas, Daiichi, Immunitybio, Incyte, Johnson & Johnson, Junshi, MBX, Nanosonics, PMV, Precision, Protalix, Sangamo, Savara.
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