Acorda Therapeutics has announced that clinical trials of Plumiaz diazepam nasal spray have failed to demonstrate bioequivalence to Diastat rectal gel, which means that the company is unable to re-file its 505(b)(2) NDA for the product. The FDA had issued a complete response letter (CRL) for the NDA in 2014. As a result, the company says that it is discontinuing … [Read more...] about Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
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Avanir launches Onzetra Xsail in the US
Avanir Pharmaceuticals has announced the launch of Onzetra Xsail sumatriptan nasal powder in the US. The FDA approved Onzetra Xsail for the treatment of migraine in adult patients in January 2016. In 2013, Avanir acquired an exclusive US license for the sumatriptan powder delivered by a bi-directional intranasal delivery device, formerly known as AVP-825, from its … [Read more...] about Avanir launches Onzetra Xsail in the US
HHS will support development of NasoShield intranasal anthrax vaccine
The US Department of Health and Human Services (HHS) has announced that its Biomedical Advanced Research and Development Authority (BARDA) has issued a $10.49 million task order to the Centers for Innovation in Advanced Development and Manufacturing (CIADM) at Texas A&M University for development and manufacturing of the NasoShield single dose intranasal anthrax … [Read more...] about HHS will support development of NasoShield intranasal anthrax vaccine
Grupo Ferrer to acquire Alexza Pharmaceuticals
Grupo Ferrer will acquire inhaled drug developer Alexza Pharmaceuticals for $0.90 per share in a deal that is expected to be completed by mid-2016, the two companies have announced. In February 2016, Alexza announced that it had signed a non-binding letter of intent regarding Ferrer's acquisition offer. Ferrer, which markets Alexza's Adasuve inhaled loxapine in … [Read more...] about Grupo Ferrer to acquire Alexza Pharmaceuticals
Marina Biotech to acquire intranasal ketamine from Turing Pharmaceuticals
Marina Biotech will pay up to $95 million in milestone payments, plus a "mid-single digit" royalty, in addition to 53 million Marina common shares to acquire Turing Pharmaceutical's intranasal ketamine program, including all existing product, clinical development plans, and intellectual property rights. The acquisition is expected to be completed by July … [Read more...] about Marina Biotech to acquire intranasal ketamine from Turing Pharmaceuticals
Aradigm announces private placement of $23 million to fund continued Pulmaquin development
Aradigm Corporation has announced the first closing of a private placement of $23 million in senior convertible notes that mature in 2021 and warrants to purchase 263,436 shares of common stock at $5.21 per share, "beginning on the later of 180 days after the date of issuance or the date the company issues a press release announcing data related to the ORBIT-3 and … [Read more...] about Aradigm announces private placement of $23 million to fund continued Pulmaquin development
Aytu acquires US rights to Acerus’s Natesto nasal testosterone
Aytu BioScience has acquired US rights to Natesto testosterone nasal gel from Acerus (formerly Trimel) for $8 million up front, including $2 million on signing and an additional $6 million by the end of FY 2017, the companies have announced. Under the deal, which extends through at least February 2024, Aytu will pay milestones of up to $37.5 million. Aytu will also … [Read more...] about Aytu acquires US rights to Acerus’s Natesto nasal testosterone
GSK opens new £56 million inhaler manufacturing facility
GlaxoSmithKline has opened a new £56 million, 4500 m2 manufacturing facility for its Ellipta DPI products. According to GSK, the new facility will create 150 jobs and will double production of Ellipta inhalers at the site to over 37 million per year by 2017. In December 2013, the company announced that it would invest ~ £200 million in UK manufacturing sites, … [Read more...] about GSK opens new £56 million inhaler manufacturing facility
Discovery Laboratories becomes Windtree Therapeutics
Discovery Laboratories, which is developing Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants, has changed its name to Windtree Therapeutics, the company said. CEO Craig Fraser, who was appointed in February 2016, commented, "Today marks a new direction in the pursuit of our mission to save and improve … [Read more...] about Discovery Laboratories becomes Windtree Therapeutics
Raptor launches Quinsair inhaled levofloxacin in Europe
Raptor Pharmaceutical has launched Quinsair levofloxacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients in Germany and Denmark, the company said. According to Raptor, it plans to launch Quinsair in Canada and in additional European countries later this year. Raptor acquired Quinsair, formerly called Aeroquin, in … [Read more...] about Raptor launches Quinsair inhaled levofloxacin in Europe