News
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The FDA has issued a notice in the Federal Register titled, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.” The agency says that its preliminary opinion is that autoinjectors with doses up… Read more . . .
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Beckley Psytech has announced that a Phase 1 SAD study of its BPL-003 intranasal dry powder synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) found that the PK profile was dose proportional and consciousness altering effects of the drug… Read more . . .
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Relief Therapeutics and NRx Pharmaceuticals (formerly NeuroRx) said that they have settled litigation that originated with a dispute over payment for a clinical trial of nebulized aviptadil (RLF-100) for the treatment of COVID-19. According to… Read more . . .
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OBG subsidiary Noveayr Therapeutics has announced the appointments of former AstraZeneca VP, Respiratory, Simon Manners as CEO and former GSK Senior VP, Respiratory, Darrell Baker as Chairman. Noveayr is the parent company of Pharmaserve NW,… Read more . . .
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Following the failure of the Phase 3 SUMMIT trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine to meet the study’s primary endpoints, Satsuma Pharmaceuticals says that the company will not… Read more . . .
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Narcan naloxone nasal spray developer Opiant Pharmaceuticals has agreed to be acquired by Indivior for $20 per share at closing, plus up to $8 contingent value rights (CVRs) per share based on achievement of revenue goals for Opiant’s OPNT003… Read more . . .
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According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca’s Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the benefit of Avillion and AstraZeneca’s PT027 albuterol / budesonide MDI for the treatment of asthma in adults outweighs the risks. However, the… Read more . . .
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CyanVac subsidiary Blue Lake Biotechnology has presented interim data from a Phase 1 trial of its BLB201 intranasal vaccine against respiratory syncytial virus (RSV) that demonstrate an increase in serum antibody responses from baseline in… Read more . . .
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Tyrvaya varenicline nasal spray maker Oyster Point Pharma announced that its board of directors has approved the company’s plans to be acquired by Viatris for $11 per share at closing plus up to $2 per… Read more . . .
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