InvisiShield Technologies, which is developing a human antibody nasal spray designed to prevent SARS-CoV-2 infection, has announced the appointment of Gladstone Institute of Virology and Immunology founding director Warner C. Greene as President and Chief Scientific Officer. Greene will continue in his role at Gladstone Institutes, where he is Senior Investigator, … [Read more...] about Warner C. Greene appointed President and CSO of InvisiShield Technologies
News
Kindeva Drug Delivery to merge with Meridian Medical Technologies
CDMO Kindeva Drug Delivery, which specializes in inhalation, intradermal, and transdermal drug delivery, has announced that it will merge with fellow Altaris Capital Partners company Meridian Medical Technologies, which specializes in autoinjectors. Altaris acquired Kindeva (formerly 3M Drug Delivery Systems) from 3M in 2020 and acquired Meridian from Pfizer in 2021. … [Read more...] about Kindeva Drug Delivery to merge with Meridian Medical Technologies
FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays
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 to 2 mg and nasal sprays with doses up to 4 mg such as Narcan nasal spray could be appropriately approved as nonprescription … [Read more...] about FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays
Beckley Psytech reports results from Phase 1 study of BPL-003 intranasal dry powder 5-MeO-DMT
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 were short-lived. The study enrolled 44 patients aged 25-55 who received single doses of BPL-003 up to 12 mg or placebo. The … [Read more...] about Beckley Psytech reports results from Phase 1 study of BPL-003 intranasal dry powder 5-MeO-DMT
Relief Therapeutics gets exclusive rights to aviptadil in settlement with NRx Pharmaceuticals
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 the companies, Relief will take possession of all NRx assets related to aviptadil, "including its regulatory filings, patent … [Read more...] about Relief Therapeutics gets exclusive rights to aviptadil in settlement with NRx Pharmaceuticals
Noveayr Therapeutics names Simon Manners as CEO, Darrell Baker as Chairman
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, which offers contract development and manufacturing for a range of OINDPs, and aerosol pharmaceutical maker Ayrton Saunders. … [Read more...] about Noveayr Therapeutics names Simon Manners as CEO, Darrell Baker as Chairman
Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
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 invest in commercialization of the product. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its … [Read more...] about Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Indivior to acquire Opiant Pharmaceuticals
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 intranasal nalmefene over a 7-year period, the company said. Both boards of directors have approved the deal, and the … [Read more...] about Indivior to acquire Opiant Pharmaceuticals
Court finds Symbicort patent invalid in win for Viatris and Kindeva
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 claims in three other patents protecting Symbicort. An appeals court reversed the March 2021 decision in December 2021 and … [Read more...] about Court finds Symbicort patent invalid in win for Viatris and Kindeva
PADAC recommends approval of PT027 albuterol/budesonide MDI for the treatment of asthma in adults
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 committee voted 9 to 8 that the risk outweighs the benefits for adolescents aged 12 to 17 and voted 16 to 1 against the use of PT027 for … [Read more...] about PADAC recommends approval of PT027 albuterol/budesonide MDI for the treatment of asthma in adults