The European Commission (EC) has approved SkyePharma's flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma in the 21 European countries using the decentralized procedure. The CHMP issued a positive opinion for flutiform in April 2012 after the 21 member states had failed to reach a consensus in late 2011. The company says that it … [Read more...] about European approval for flutiform
News
EPAG recommends further investigation of low volume cascade impaction for DPIs
A study by the European Pharmaceutical Aerosol Group (EPAG) titled "Effect of Sampling Volume on Dry Powder Inhaler (DPI)-Emitted Aerosol Aerodynamic Particle Size Distributions (APSDs) Measured by the Next-Generation Pharmaceutical Impactor (NGI) and the Andersen Eight-Stage Cascade Impactor (ACI)" and published on June 8, 2012 by AAPS PharmSciTech finds that reduced … [Read more...] about EPAG recommends further investigation of low volume cascade impaction for DPIs
Insmed gets $20 million loan
According to Insmed Incorporated, the company has entered into a loan agreement with Hercules Technology Growth Capital that will allow it to access up to $20 million for continued development of Arikace inhaled liposomal amikacin. Hercules received a warrant to purchase 329,932 shares of Insmed common stock at $2.94 per share as part of the agreement. Insmed … [Read more...] about Insmed gets $20 million loan
CHMP issues positive recommendation for Seebri Breezhaler
According to Novartis, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Seebri Breezhaler glycopyrronium/NVA237 DPI for the treatment of COPD. Novartis submitted the MAA in September 2011. "This positive opinion for Seebri Breezhaler is a major milestone in our efforts to offer COPD patients and … [Read more...] about CHMP issues positive recommendation for Seebri Breezhaler
Regency launches study of Sprix ketorolac nasal spray
Regency Therapeutics has announced the initiation of the 18-month AMPED (Acute Management of Pain from the Emergency Department) registry study to compare patient response to Sprix ketorolac tromethamine nasal spray used to treat pain in emergency departments to outcomes for patients prescribe oral narcotics. The study will be conducted in 15 hospitals, including the … [Read more...] about Regency launches study of Sprix ketorolac nasal spray
Alexza resubmits Adasuve inhaled loxapine NDA
Alexza Pharmaceuticals says that it has resubmitted its NDA for Adasuve inhaled loxapine for the treatment of agitation in patients with bipolar disorder or schizophrenia; the company received a Complete Response Letter for the Adasuve NDA in May 2012. The company says that it expects a response from the FDA as to how the resubmission will be classified and the new … [Read more...] about Alexza resubmits Adasuve inhaled loxapine NDA
GSK gets rights to certain Liquidia Technologies inhalation candidates
GlaxoSmithKline has acquired rights to several inhaled drug candidates manufactured using Liquidia Technologies' PRINT (Particle Replication In Non-Wetting Templates) platform. The PRINT nanofabrication technology produces particles with narrow size distribution and any desired shape. According to Liquidia, the total value of the deal, including an upfront payment, … [Read more...] about GSK gets rights to certain Liquidia Technologies inhalation candidates
Hovione sales up 24%
Particle design and dry powder inhalation specialist Hovione has announced that sales for the fiscal year that ended in March, 2012 increased to $180 million,a 24% increase over the previous year. In addition to inhalation formulation development and manufacturing, the company also licenses its proprietary dry powder inhalers. Hovione CFO Miguel Calado commented, … [Read more...] about Hovione sales up 24%
MicroDose Therapeutx and Moerae Matrix to collaborate on inhaled MK2 inhibitor
MicroDose Therapeutx and Moerae Matrix have agreed to collaborate on development of a dry powder inhaler, using MicroDose DPI technology to deliver Moerae’s MMI-0100 MK2 inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). There are no treatments for IPF currently approved in the US. According to the companies, "MMI-0100 is a selective inhibitor of … [Read more...] about MicroDose Therapeutx and Moerae Matrix to collaborate on inhaled MK2 inhibitor
Judge rules for Apotex in Merck’s Nasonex patent infringement suit
According to Bloomberg News, Merck plans to appeal a ruling by Judge Peter Sheridan of the US District Court for the District of New Jersey that Merck failed to prove its allegation that Apotex infringed on its Nasonex patent. At the same time, the judge upheld the validity of the patent, which Apotex had challenged. Apotex filed an ANDA for mometasone nasal … [Read more...] about Judge rules for Apotex in Merck’s Nasonex patent infringement suit