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
Business
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
Viatris to acquire Oyster Point Pharma
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 share if Oyster Point achieves certain performance goals for 2022. The FDA approved Tyrvaya for the treatment of dry eye disease in October 2021. Oyster Point is also … [Read more...] about Viatris to acquire Oyster Point Pharma
TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
Birmingham Biotech launches NoriZite gelling nasal spray for the prevention of viral infections in the UK
Birmingham Biotech has announced the launch of NoriZite carageenan/gellan gum nasal spray for the prevention of viral infections in the UK. The formulation, which is designed to physically block viruses in the nasal cavity, was developed at the University of Birmingham's Healthcare Technologies Institute, and Birmingham Biotech acquired the rights to the nasal spray … [Read more...] about Birmingham Biotech launches NoriZite gelling nasal spray for the prevention of viral infections in the UK
United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
According to Liquidia, the US Patent and Trademark Office's Precedential Opinion Panel (POP) will not review a July 2022 Patent Trial and Appeals Board (PTAB) decision which determined that none of the claims in US Patent No. 10,716,793, which covers United Therapeutics' Tyvaso inhaled treprostinil, are valid. United Therapeutics had requested both a POP review of the … [Read more...] about United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
Lupin acquires US rights to Brovana inhalation solution and Xopenex HFA MDI
Lupin Limited announced that it will pay Sunovion $75 million for the rights to Brovana arformoterol inhalation solution and Xopenex HFA levalbuterol MDI. Brovana has been approved in the US for the treatment of COPD since 2006, and Lupin launched an authorized generic of the inhalation solution in June 2021. Xopenex was initially approved for the treatment of asthma … [Read more...] about Lupin acquires US rights to Brovana inhalation solution and Xopenex HFA MDI
Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19
According to CDMO GenScript ProBio, the company has signed an agreement with Thai company Hibiocy for manufacturing of Covitrap, an intranasal antibody cocktail for the prevention of COVID-19. GenScript said that the deal includes both clinical trial and commercial manufacturing of Covitrap, as well as work on development of new products. The company said that … [Read more...] about Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19
Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
Transpire Bio, which previously announced deals with Recipharm for development of four inhaled products, announced a new deal with INTO (Inhalation Together) for development of three additional inhaled products: TRB-5, TRB-6 and TRB-7. INTO is a partnership between DFE Pharma, Sterling, and Harro Höfliger that was formed earlier this year to provide early development … [Read more...] about Transpire Bio announces development deal with INTO and names new Chief Scientific Officer