There are coincidences and then there are big coincidences, the latter of which might describe a new U.S. FDA draft guidance and a major cybersecurity breach. The agency has issued a draft update to its premarket cybersecurity guidance even as the Department of Health and Human Services announced an investigation into the hack of the IT system at Change Healthcare, a pair of developments that seem likely to set the world of connected medical devices on its collective ear.
After hearing two conflicting presentations of the safety and efficacy of Geron Corp.’s imetelstat, the U.S. FDA’s Oncology Drugs Advisory Committee (ODAC) voted 12-2 March 14 that the drug’s benefit outweighed its risks as a treatment for transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes in patients who have failed or no longer respond to erythropoiesis stimulating agents (ESAs), or who are not eligible for ESA treatment.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.
Xgene Pharmaceutical Pty Ltd., a subsidiary of Xgene Pharmaceutical Co. Ltd., has received approval in Australia to initiate a phase I trial of the selective TRPM8 blocker XG-2002 (RQ-00434739).
Shanghai Henlius Biotech Inc.’s IND application for HLX-6018, a novel anti-glycoprotein-A repetitions predominant (GARP)/transforming growth factor-β1 (TGF-β1) monoclonal antibody (mAb), has received approval by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF).
There’s no denying that Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Co.’s Abecma (idecabtagene vicleucel) show clinical benefit as they seek to move up in the line of treatment for relapsed or refractory multiple myeloma. But the question that will be put to the U.S. FDA’s Oncology Drugs Advisory Committee March 15 is whether the benefit outweighs a risk of early deaths seen with both CAR T therapies.
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.
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