California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by … [Read more...] about Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
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Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The nasal spray will be marketed under store brand names. Flonase was approved for over-the-counter sales in the US in 2014. Hikma … [Read more...] about Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Vectura partners with Propeller Health to develop connected inhalers
Vectura Group and Propeller Health have announced that they will partner to develop a connected version of Vectura's LOMI (lever-operated multi-dose inhaler) DPI using Propeller's digital technology. The LOMI device, which is based on Vectura's GyroHaler, uses blister strips to deliver up to 60 doses. According to the announcement, discussions are underway to … [Read more...] about Vectura partners with Propeller Health to develop connected inhalers
Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
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
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