Two experts in particle manufacturing for inhaled dry powder formulations, Hovione and Bend research, have entered into a non-exclusive collaboration in which they will have access to each other's technologies. The partnership also gives Bend access to Hovione's commercial manufacturing capabilities in Portugal, Ireland, China, and the US. “Hovione has world-class … [Read more...] about Hovione and Bend agree to collaborate on inhalation technologies, manufacturing
News
Insight recalls lot of Nostrilla nasal decongestant spray
Insight Pharmaceuticals has voluntarily recalled a single lot of its Nostrilla oxymetazoline hydrochloride nasal spray due to possible contamination with Burkholderia cepacia bacteria. Nostrilla is available without prescription, and lot #11G075, which consisted of 34,092 1/2-oz bottles, was distributed in US retail stores and pharmacies. According to Insight, it has … [Read more...] about Insight recalls lot of Nostrilla nasal decongestant spray
New rapid proof of concept service for dry powder inhalation products from Hovione
Hovione has launched a new service to provide proof of concept formulation for new dry powder formulations within a few weeks. The company says that its Rapid Proof of Concept Study will further simplify DPI development and reduce the time required for development projects. Hovione VP of Pharma & Innovation Peter Villax commented, “This new Rapid Proof of Concept … [Read more...] about New rapid proof of concept service for dry powder inhalation products from Hovione
Concerned Member States fail to reach consensus on Flutiform MAA
SkyePharma has announced a delay in the review of the European Marketing Authorisation Application ("MAA") for the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) because the 21 Concerned Member States failed to reach consensus during the designated time period. Mundipharma, which has licensed European rights to Flutiform, filed the MAA … [Read more...] about Concerned Member States fail to reach consensus on Flutiform MAA
Perrigo files an ANDA for a generic Patanase nasal spray; Alcon files suit
According to Perrigo, Alcon Labs has filed a patent infringement suit in the United States District Court for the Northern District of Texas after Perrigo filed an abbreviated new drug application (ANDA) for a generic version of Alcon's Patanase olopatadine hydrochloride nasal spray. The FDA approved Alcon's NDA for Patanase for the treatment of seasonal allergic … [Read more...] about Perrigo files an ANDA for a generic Patanase nasal spray; Alcon files suit
Some acetylcysteine inhalation solution now available
According to the FDA, American Regent/Luitpold has now released several batches of acetylcysteine inhalation solution, including 10 ml vials of both 100 mg/ml and 200 mg/ml solutions and 30 ml vials of the 200 mg/ml solution. The company's facility in Shirley, NY was closed in April 2011 due to safety concerns. Two other manufacturers, Roxanne Laboratories and … [Read more...] about Some acetylcysteine inhalation solution now available
Fentanyl nasal spray now available in the US
Archimedes Pharma has officially launched its Lazanda fentanyl nasal spray for the treatment of breakthrough pain in adult cancer patients in the United States. Lazanda, the first fentanyl nasal spray available in the US, was approved by the FDA at the end of June 2011. In Europe, where the product is marketed as PecFent, the spray is available in a handful of … [Read more...] about Fentanyl nasal spray now available in the US
FDA requires more data on Arikace inhaled amikacin for NTM lung disease
Days after Insmed announced that the FDA was continuing its hold on Phase 3 clinical trials of Arikace inhaled liposomal amikacin for the treatment of cystic fibrosis, the company says that the FDA has also requested additional data on Arikace before continuing a Phase 3 trial in patients with non-tuberculous mycobacterial (NTM) lung disease. The FDA initially … [Read more...] about FDA requires more data on Arikace inhaled amikacin for NTM lung disease
Azelon gets financing for osteoporosis nasal spray, adds to management team
Prospect Venture Partners, Lighthouse Capital Partners, and Covington Venture Fund will provide a total of $4.5 million in Series A financing to Azelon Pharmaceuticals, formerly Zelos Therapeutics, for continued clinical development of Azelon’s ZT-034 teriparatide nasal spray for the treatment of osteoporosis. Teriparatide is a parathyroid hormone analog and is … [Read more...] about Azelon gets financing for osteoporosis nasal spray, adds to management team
Acton publishes positive Phase 3b data for flunisolide inhaler
Acton Pharmaceuticals has published positive results from a Phase 3b clinical trial of its Aerospan flunisolide HFA metered dose inhaler in the October issue of Annals of Allergy, Asthma & Immunology. The article, titled, "Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled hydrofluoroalkane in prepubescent children with mild persistent … [Read more...] about Acton publishes positive Phase 3b data for flunisolide inhaler