Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality systems by ANVISA conducted in November 2013. The certification means that Next Breath is now the only laboratory outside of … [Read more...] about Next Breath certified by ANVISA as Center for Pharmaceutical Equivalence
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Merck licenses adjuvant technology from NanoBio for intranasal RSV vaccine
NanoBio has announced that Merck has acquired exclusive rights to NanoBio's NanoStat nanoemulsion adjuvant for an intranasal respiratory syncytial virus (RSV) vaccine. Merck also acquired non-exclusive rights to the adjuvant for use in an intranasal flu vaccine. The amount of the deal, which includes an upfront payment, milestone payments, and royalties on any sales … [Read more...] about Merck licenses adjuvant technology from NanoBio for intranasal RSV vaccine
Avanir announces acceptance of its NDA for AVP-825 dry powder intranasal sumatriptan
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
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