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. Read More

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. Read More

Similarities among three pediatric brain tumors that arise in different structures of the CNS – pineoblastoma, retinoblastoma and Group 3 medulloblastoma – have been linked to their shared origin during pineal gland development. Scientists at St. Jude Children’s Research Hospital have identified the molecular signatures that drive these tumors from pinealocyte progenitor cells that conserve a common differentiation program, providing a shared therapeutic target for these three cancer types. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Calidi, Longeveron, Max, May Health, Neuros, Theralase, Technomark, Trinity. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Aptevo, Arcutis, Ascletis, Celcuity, Citius, Edgewise, Excellthera, Kainova, Neurosense, NMD, SAB, Satellos, Telix, Tonix, Vertex. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Ardelyx, Axena, Beyond Air, Biontech, Cassava, Celularity, Cliniquantum, Dario, Erasca, Genedx, Glooko, Guardant, Joyo, Mink, Neuronos, Neurothera, Novo Nordisk, Quest, Scisparc, XLT, Zevra. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Biocartis, Capricor, Centauri, Eledon, Genfit, Incyte, Johnson & Johnson, Lenz, Mineralys, QT Imaging, Soligenix. Read More