Novartis has announced that its Ultibro Breezhaler indacaterol/glycopyrronium DPI (QVA149) has gotten a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for the treatment of COPD. The company filed an MAA for the product in October 2012. Novartis Division Head David Epstein commented, "The CHMP's positive opinion supports a … [Read more...] about CHMP issues positive opinion for Ultibro Breezhaler
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Pulmatrix initiates Phase 1B study of DPI for COPD
Pulmatrix has initiated a Phase 1B study of its PUR0200, an inhaled LAMA for the treatment of COPD, the company says. PUR0200 is a lactose-free formulation created using the company's iSPERSE particle engineering technology. Pulmatrix Chief Scientific Officer David Hava said, “PUR0200 has demonstrated outstanding performance in preclinical evaluation models of … [Read more...] about Pulmatrix initiates Phase 1B study of DPI for COPD
Court finds that Teva’s generic Perforomist infringes on Mylan patent
Mylan has announced that the United States District Court for the Northern District of West Virginia granted a Mylan motion for partial summary judgment and found that Teva's generic formoterol fumarate inhalation solution infringes US Patent No. 6,667,344 on Mylan's Perforomist inhalation solution. The court will hear arguments on other issues in the case later this … [Read more...] about Court finds that Teva’s generic Perforomist infringes on Mylan patent
Activaero system used in new Ablynx Phase 1 studies of inhaled Nanobody for RSV
Activaero has announced that its FAVORITE (flow and volume regulated inhalation technology) system is being used for additional Phase 1 studies of Ablynx's Nanobody ALX-0171 for the treatment of respiratory syncytial virus (RSV). Results from a previous Phase 1 study of the drug were announced in September 2012. Ablynx President and CEO Edwin Moses recently … [Read more...] about Activaero system used in new Ablynx Phase 1 studies of inhaled Nanobody for RSV
Presspart hires Sameer Kunte as Customer Services Manager for India
MDI component manufacturer Presspart has hired Sameer Kunte as its new Customer Services Manager for India, the company said. Kunte has extensive experience with OINDP device development and has worked previously for 3M, Dr. Reddy's, and Lupin. Presspart Pharmaceutical Sales Director Julian Hemy said, “We are delighted to welcome Sameer – his experience and … [Read more...] about Presspart hires Sameer Kunte as Customer Services Manager for India
Insmed announces public offering of common stock
Insmed Incorporated has announced a proposed underwritten public offering of $60 million of its common stock to fund continued clinical development, regulatory efforts, and commercialization of Arikace inhaled liposomal amikacin, its lead product. The company says that it will also use the funding "to invest in third-party manufacturers and the supply chain in … [Read more...] about Insmed announces public offering of common stock
GSK and Theravance withdraw Relvar application in Japan
GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the companies say. Review of the JNDA, which was submitted in September 2012, will continue for the FF/VI combination inhaler for the treatment of asthma. If approved, the … [Read more...] about GSK and Theravance withdraw Relvar application in Japan
Breo Ellipta approved in Canada
GlaxoSmithKline has announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved for the treatment of COPD in Canada. GlaxoSmithKline Inc. President Paul Lirette said, "For over forty years, GlaxoSmithKline has been at the forefront of delivering medicines to patients with respiratory diseases. We are committed to responding to patients' … [Read more...] about Breo Ellipta approved in Canada
Astech Projects offers free consultation to celebrate anniversary
Inhaler testing automation supplier Astech Projects is celebrating its 18th anniversary on July 18, 2013 by offering a free consultation and proposal for a laboratory automation system. The company manufactures semi- to fully-automated dose content uniformity, Andersen cascade impactor (ACI), and Next Generation Impactor (NGI) testing systems, plus a number of other … [Read more...] about Astech Projects offers free consultation to celebrate anniversary
Court issues final judgment in Perforomist case in favor of Mylan
The US District Court for the Southern District of New York has issued a final judgment and order affirming the validity of five patents related to Mylan's Perforomist formoterol fumarate inhalation solution and stating that Sunovion's Brovana inhalation solution infringes the Mylan patents. Mylan had appealed after the five patents were invalidated in March 2012; two … [Read more...] about Court issues final judgment in Perforomist case in favor of Mylan