Depomed has announced that it has paid $4 million for US and Canadian rights to Lazanda fentanyl nasal spray from Archimedes Pharma Limited. Lazanda was approved by the FDA for the treatment of breakthrough cancer pain in June 2011, and Archimedes launched the product in the US in October 2011. The product is known as PecFent in Europe, where it was approved in 2010. … [Read more...] about Depomed acquires fentanyl nasal spray from Archimedes
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Cirrus Pharmaceuticals acquired by Kemwell Biopharma
Indian contract research and manufacturing company Kemwell Biopharma has acquired North Carolina-based CRO Cirrus Pharmaceuticals, which offers development services for inhaled and nasal drugs among other dosage forms. Cirrus also provides analytical services for OINDPs. Cirrus President Anthony Hickey comented, "This acquisition is a testament to the tremendous … [Read more...] about Cirrus Pharmaceuticals acquired by Kemwell Biopharma
CHMP issues positive opinion for Ultibro Breezhaler
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
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