Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Esculetin, also known as 6,7-dihydroxycoumarin, is a coumarin-derived phytochemical that has shown effects against ischemic stroke. Additionally, chemokine-like factor 1 (CKLF1) has been revealed in previous findings to be a target for stroke when using coumarin-derived compounds. The effects of esculetin and the potential involvement of CKLF1 were tested in photothrombotic stroke in mice.
Piplartine, also called piperlongumine, had protective effects against hearing loss induced by aminoglycoside antibiotics in zebrafish and mouse models of kanamycin-induced hair cell loss. Kanamycin is a member of the aminoglycosides, a group of antibiotics that have broad-spectrum activity against gram-negative bacteria, including multidrug resistant strains.
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.
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.
Halda Therapeutics Inc. announced it has secured an additional $126 million in funding in a series B extension, bringing its total funding to date to $202 million. The company expects its lead molecule HLD-0915 to enter a phase I trial in the first half of 2025 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
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