According to Insmed, the US Patent and Trademark Office has issued the company a second composition of matter patent for Arikace liposomal amikacin for inhalation, US Patent No. 8,226,975. Insmed is developing the product for the treatment of cystic fibrosis and non-tuberculous mycobacteria (NTM). The company recently decided to defer a Phase 3 study of Arikace in the … [Read more...] about Insmed gets additional patent for Arikace
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Aptar dose indicator on newly-approved nasal aerosol
Aptar Pharma has announced that the Zetonna nasal aerosol device recently launched in the US includes a customized Aptar Landmark dose indicator, the result of a six-year collaboration with Sunovion. Zetonna is delivered by a pressurized metered dose inhaler, and the FDA recommends that all new pMDI products have an integrated dose counter. Aptar Pharma … [Read more...] about Aptar dose indicator on newly-approved nasal aerosol
Watson gets FDA approval for budesonide, sued over levalbuterol
The FDA has approved Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with AstraZeneca. Watson says that it if it prevails in court, it will launch the budesonide product by the end of this … [Read more...] about Watson gets FDA approval for budesonide, sued over levalbuterol
Lupin to market Onbrez inhalation capsules in India
According to a report in The Business Standard, Novartis India has announced an agreement with Lupin to sell the Onbrez indacaterol inhalation capsules for the treatment of COPD in India. The newspaper cited "an industry source" for the information. The article says that the capsules would be available in two doses, 150 mg and 300 mg. Few other details were … [Read more...] about Lupin to market Onbrez inhalation capsules in India
Sunovion launches Zetonna nasal aerosol in US
According to Sunovion Pharmaceuticals, Zetonna ciclesonide nasal aerosol for the treatment of perennial and seasonal allergic rhinitis is now available throughout the US. The company announced in May that it would launch the product by this fall. Sunovion also markets Omnaris ciclesonide nasal spray for the treatment of allergic rhinitis and Alvesco ciclesonide … [Read more...] about Sunovion launches Zetonna nasal aerosol in US
Quintiles to promote Almirall respiratory products in UK, beginning with Eklira Genuair
Quintiles will promote respiratory drugs from Almirall in the UK, starting with the newly approved Eklira Genuair aclidinium bromide dry powder inhaler for the treatment of COPD. Quintiles performed some of the clinical study work for the product. Menarini will market the DPI in most of Europe as Bretaris Genuair. Almirall UK General Manager Carlos Gallardo … [Read more...] about Quintiles to promote Almirall respiratory products in UK, beginning with Eklira Genuair
Unigene responds to EMA recommendation against use of calcitonin nasal spray
Unigene Laboratories, which manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis, has requested product safety data submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP) in response to the EMA's recommendation against use of calcitonin nasal sprays. The EMA report, issued on July 19, 2012, notes a 2.4% increase in the … [Read more...] about Unigene responds to EMA recommendation against use of calcitonin nasal spray
“Asthma Inhalers Relief Act of 2012” aims to allow sales of remaining CFC inhalers
The US House of Representatives held a meeting on July 18, 2012 regarding the "Asthma Inhalers Relief Act of 2012," which is intended "To direct the Administrator of the Environmental Protection Agency to allow for the distribution, sale, and consumption in the United States of remaining inventories of over-the-counter CFC epinephrine inhalers." Witnesses who … [Read more...] about “Asthma Inhalers Relief Act of 2012” aims to allow sales of remaining CFC inhalers
Alexza gets $20 million in new funding
Alexza Pharmaceuticals has announced that it has issued 80,429 shares of common stock to Azimuth Opportunity as the two companies have reached an agreement for a committed equity financing facility under which Alexza has the option to sell Azimuth up to $20 million of its registered common stock over 2 years. The two companies entered a similar agreement in May 2010 … [Read more...] about Alexza gets $20 million in new funding
UK supermarket chain to begin selling inhalers over the counter
Supermarket chain Asda says that it will become the first retailer in the UK to sell asthma reliever inhalers over the counter when its pharmacies begin offering salbutamol (albuterol) inhalers for sale on July 24. Asda has pharmacies in 218 stores. Patients over the age of 16 will be able to purchase two inhalers for £7 after filling out a simple questionnaire. … [Read more...] about UK supermarket chain to begin selling inhalers over the counter