Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company's AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014. According to Avanir, the PDUFA goal date is November 26, 2014. AVP-825 was developed by OptiNose for delivery using OptNose's … [Read more...] about Avanir announces acceptance of its NDA for AVP-825 dry powder intranasal sumatriptan
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BARDA awards $8.3 million to SwRI for intranasal isoamyl nitrite development
Non-profit R&D organization Southwest Research Institute (SwRI) has announced that it has received a 28-month contract extension worth $8.3 million from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) for continued development of an intranasal isoamyl nitrite formulation for the treatment of cyanide … [Read more...] about BARDA awards $8.3 million to SwRI for intranasal isoamyl nitrite development
Mixed results in Phase 2 study of Arikayce for NTM lung infections
Insmed has announced that in a Phase 2 clinical trial of Arikayce (formerly Arikace) inhaled liposomal amikacin for nontuberculous mycobacterial (NTM) lung infections, the product failed to produce a statistically significant reduction in mycobacterial density; however, it did meet a secondary endpoint, with significantly more patients treated with Arikayce having … [Read more...] about Mixed results in Phase 2 study of Arikayce for NTM lung infections
Vectura gets additional milestone payment for development of VR315 in the US
Vectura has announced that under a license agreement with "the US division of a leading international pharmaceutical company" signed in 2011, it has reached a milestone associated with the US development of its VR315 salmeterol/fluticasone DPI (known as AirFluSal Forspiro in Europe). According to the company, it received a payment of $10 million in August 2011 and … [Read more...] about Vectura gets additional milestone payment for development of VR315 in the US
3M Drug Delivery Systems names Cindy Kent President and General Manager
3M Drug Delivery Systems has announced that Cindy R. Kent has succeeded James Ingebrand as President and General Manager, effective February 2014. Ingebrand will now head 3M's dental division. Kent joined 3M in October 2013 as VP of Strategy, Business Development and US Medical Key Accounts for 3M Healthcare. She holds degrees in industrial engineering, management, … [Read more...] about 3M Drug Delivery Systems names Cindy Kent President and General Manager
GSK gets preliminary injunction preventing sales of AirFluSal Forspiro in Germany
According to a report in the Wall Street Journal, a court in Cologne, Germany has issued a preliminary injunction preventing Sandoz from marketing its AirFluSal Forspiro in Germany. GlaxoSmithKline had argued that Sandoz's salmeterol/fluticasone DPI presented unfair competition to GSK's Advair because the purple color of the Forspiro inhaler would lead consumers to … [Read more...] about GSK gets preliminary injunction preventing sales of AirFluSal Forspiro in Germany
US district court upholds validity of Mylan Perforomist patents
According to Mylan, the United States District Court for the Northern District of West Virginia has upheld the validity of all of its patents related to Perforomist formoterol fumarate inhalation solution. The company says that the ruling will prevent the FDA from approving Teva's ANDA for its formoterol fumarate inhalation solution before expiration of patents … [Read more...] about US district court upholds validity of Mylan Perforomist patents
Kamada initiates Phase 2 study of inhaled alpha-1 antitrypsin
Israeli pharmaceutical company Kamada has initiated a US Phase 2 trial of its inhaled alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency, also known as inherited emphysema. The company also announced a delay in reporting results from a Phase 2/3 study of the product in Europe and Canada and said that it now expects to report top-line results from that … [Read more...] about Kamada initiates Phase 2 study of inhaled alpha-1 antitrypsin
Spacer manufacturer Medical Developments partners with Asthma UK
Medical Developments UK (MDUK) has announced that it will donate 25p from the sale of each of its pMDI spacers in the UK to Asthma UK. MDUK is part of Medical Developments International, whose Space Chamber line of valved holding chambers was launched in the spring of 2013. The company also markets a portable nebulizer. Asthma UK Clinical Lead Deborah Waddell … [Read more...] about Spacer manufacturer Medical Developments partners with Asthma UK
Formex names Steve Massah President and CEO
CDMO Formex, formerly PharmaForm, has hired Steve Massah as President and CEO. Massah joins Formex from Gilead, where he worked in Strategic Drug Product Manufacturing and Outsourcing. He has previously held management positions with Avanir, ISTA, and Neurocrine Biosciences. Formex Chairman Masood Tayebi commented, "Steve brings a wealth of knowledge and expertise … [Read more...] about Formex names Steve Massah President and CEO