Renaissance Acquisition Holdings has acquired Texas-based CDMO DPT Laboratories, which offers MDI and nasal spray testing and manufacturing. DPT has facilities in San Antonio, TX and Lakewood, NJ. According to the company, the management team and business will continue as before. DPT President and COO Paul Johnson commented, “Renaissance and its management team … [Read more...] about DPT Labs acquired by Renaissance
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Cipla hires Frank Pieters to head respiratory business
Indian pharmaceutical company Cipla has hired former Teva vice-president Frank Pieters as Head of European Business and Head of Global Respiratory Business. Pieters was most recently Senior VP for the Region of Southern Europe at Teva. Cipla manufactures a wide range of inhaled medications. A recent article in the Business Standard quotes Cipla CFO S Radhakrishnan … [Read more...] about Cipla hires Frank Pieters to head respiratory business
Prosonix and Imperial College London to collaborate on inhaled drugs
Prosonix and Imperial College London have signed an agreement to collaborate on development of inhaled therapies based on multi-component particles (MCPs) manufactured using Prosonix's proprietary particle engineering technology. The company will coordinate with Dr. Omar Usmani of the college's National Heart and Lung Institute (NHLI) to perform in vivo and in vitro … [Read more...] about Prosonix and Imperial College London to collaborate on inhaled drugs
Results from four Phase 3 studies of GSK’s LAMA/LABA inhaler for COPD
GlaxoSmithKline and Theravance have announced results from four Phase 3 studies of its umeclidinium bromide (UMEC)/vilanterol (VI) combination DPI for the treatment of COPD. The studies include two 24-week efficacy studies and two 24-week active comparator studies comparing UMEC/VI with tiotropium. UMEC is a a long-acting muscarinic antagonist (LAMA) and vilanterol is … [Read more...] about Results from four Phase 3 studies of GSK’s LAMA/LABA inhaler for COPD
European approval for flutiform
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
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