In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
After many months of jockeying, the U.S. FDA has approved Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) for treating hypoparathyroidism. Ascendis said this is the first and only treatment for adults with the rare endocrine disease.
Cullinan Therapeutics Inc. terminated development of Harbour Biomed Holdings Ltd.’s bispecific B7H4 x 4-1BB immune activator, CLN-418 (HBM-7008), after reviewing phase I data.
The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.
An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.
The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.
In what represents the first patenting to emerge in the assignee’s name, additional protection is being sought for Rapidpulse Inc.’s aspiration system, which delivers high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy and remove thrombus from the neurovasculature.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Concerns of lower-than-expected efficacy, which prompted AN2 Therapeutics Inc. to pause enrollment in the phase III portion of the phase II/III trial earlier this year, turned out to be well-founded, as top-line data proved disappointing for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease. As a result, the company is dropping the program and restructuring.
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