The US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has awarded a Small Business Initiative Research (SBIR) grant of approximately $278,000 to Aradigm to study the use of Aradigm’s Pulmaquin and Lipoquin inhaled liposomal ciprofloxacin products for the treatment of pulmonary non-tuberculous mycobacteria … [Read more...] about Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
News
FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC
According to Sanofi, the FDA's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If the FDA approves the application, Sanofi's consumer healthcare division, Chattem, Inc. will market Nasacort AQ. Sanofi US Chief … [Read more...] about FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC
Alexza promotes two in management positions
Alexza Pharmaceuticals has announced that it has created two new positions, Vice President, Global Strategic Marketing and New Product Planning and Vice President, Business Development and Global Alliance Management and has promoted Kelly Seither and Tatjana Naranda to fill those positions. Seither has worked for Alexza since 2003 and Naranda since 2005. Alexza's … [Read more...] about Alexza promotes two in management positions
Intranasal aerosol proposed as treatment for snakebite
A group of researchers has published an article in Clinical Case Reports describing successful reversal of induced paralysis in a human volunteer after administration of intranasal aerosolized neostigmine, an anticholinesterase. According to the article, IV administration of anticholinesterases is the first-line treatment for neurotoxic snakebite when antivenom is … [Read more...] about Intranasal aerosol proposed as treatment for snakebite
Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed "said they prefer to rely on medical professionals to diagnose and manage their conditions." According to the organization, the survey also showed that more … [Read more...] about Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays
Adasuve inhaled loxapine launched in Europe
Grupo Ferrer Internacional has launched Adasuve Staccato loxapine in Germany, triggering a $1.25 million milestone payment to Adasuve developer and manufacturer Alexza Pharmaceuticals, Alexza has announced. Adasuve was approved in the EU in February 2013 for use in hospital settings for the treatment of agitation in schizophrenic or bi-polar patients. Grupo Ferrer … [Read more...] about Adasuve inhaled loxapine launched in Europe
Depomed acquires fentanyl nasal spray from Archimedes
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
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