AIR001 developer Mast Therapeutics will merge with AeroVanc and Molgradex developer Savara, the companies have announced. Savara's current management team will lead the combined company, which will be called Savara Inc and which will trade under a new stock ticker symbol. After the merger, current Savara stockholders will own ~76% of the combined company, and current … [Read more...] about Mast Therapeutics to merge with Savara
News
Satsuma Pharmaceuticals spins out from SNBL to develop intranasal dihydroergotamine
Satsuma Pharmaceuticals, a spin out from Shin Nippon Biomedical Laboratories (SNBL) has closed a $12 million Series A financing co-led by RA Capital Management and TPG Biotech, the company said. Proceeds will be used to fund development of the company's STS101 dihydroergotamine (DHE) intranasal dry powder for the treatment of migraines. In 2013, SNBL announced … [Read more...] about Satsuma Pharmaceuticals spins out from SNBL to develop intranasal dihydroergotamine
BAT returns Voke inhaler rights to Kind Consumer
Days after its subsidiary Nicovations cancelled supply agreements with Bespak, British American Tobacco says that it and Kind Consumer "have reached a mutually satisfactory agreement on the financial aspects" on "a new approach to commercialize the Voke nicotine inhaler" in which BAT will return the rights to the inhaler to Kind, "allowing Kind to embrace the full … [Read more...] about BAT returns Voke inhaler rights to Kind Consumer
Neurelis gets Fast Track designation for intranasal diazepam
Neurelis has announced that its NRL-1 intranasal diazepam has received Fast Track designation from the FDA for the treatment of acute repetitive or cluster seizures in epilepsy patients. The company plans to submit an NDA for the product by early 2018. The FDA granted NRL-1 orphan drug designation in 2015, and Neurelis announced the initiation of pivotal trials in … [Read more...] about Neurelis gets Fast Track designation for intranasal diazepam
Nicovations terminates Bespak supply agreements for Voke nicotine inhaler
Bespak parent company Consort Medical has confirmed that British American Tobacco subsidiary Nicovations has terminated its supply agreements with Bespak for the Voke nicotine inhaler, effective immediately. According to Consort, Nicovations invoked a clause in the agreement allowing it to cancel in the event that the product failed to reach commercial launch by 31 … [Read more...] about Nicovations terminates Bespak supply agreements for Voke nicotine inhaler
Amphastar gets complete response letter for Primatene Mist
Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would require an additional human factors validation study as well as label and packaging changes. The original version of Primatene … [Read more...] about Amphastar gets complete response letter for Primatene Mist
Vectura and Mundipharma sign development deal for triple therapy MDI
Vectura and Mundipharma have signed an agreement for the development and commercialization of the VR2076 ICS/LABA/LAMA MDI, Vectura has announced. Skyepharma, which was acquired by Vectura earlier this year, had previously announced a development and commercialization deal for the MDI, then known as SKP-2076, in December 2015. Mundipharma and a "US associated … [Read more...] about Vectura and Mundipharma sign development deal for triple therapy MDI
Cipla’s Sereflo fluticasone/salmeterol MDI approved in UK
According to Cipla, its Sereflo fluticasone/salmeterol MDI, a generic version of Advair (Seretide), has been approved by the UK MHRA for the treatment of asthma, and the product will be launched by a partner in the UK within a few weeks. Cipla Ltd. Global CEO Umang Vohra commented, “We are extremely pleased with the approval of Sereflo in the UK. This is a … [Read more...] about Cipla’s Sereflo fluticasone/salmeterol MDI approved in UK
Horizon launches Quinsair inhaled levofloxacin in Canada
Horizon Pharma has announced that Quinsair levofloxacin inhalation solution is now available in Canada for the treatment of P. aeruginosa lung infections in adult cystic fibrosis patients. Horizon acquired Quinsair when it acquired Raptor Pharmaceutical company in October 2016. Raptor launched Quinsair in Europe in April 2016. Horizon Pharma VP and General Manager, … [Read more...] about Horizon launches Quinsair inhaled levofloxacin in Canada
Orion announces plan to submit MAA for salmeterol/fluticasone Easyhaler in 2017
Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017. The company said that its plan to submit the MAA is based on recently received positive results from a PK study. Orion Senior VP, Pharmaceutical … [Read more...] about Orion announces plan to submit MAA for salmeterol/fluticasone Easyhaler in 2017