Ken Cunningham, who recently joined the board of UK pharmaceutical and particle engineering company Prosonix, will lead the company's new scientific advisory board. Joining Cunningham on Prosonix's SAB are: Peter Barnes, Professor of Thoracic Medicine and Head of Airway Disease, National Heart and Lung Institute, and Honorary Consultant Physician, Royal Brompton … [Read more...] about New scientific advisory board for Prosonix
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Acton Pharmaceuticals will develop and market Nasacort HFA in US
Massachusetts respiratory pharmaceutical company Acton Pharmaceuticals has entered into a licensing agreement with Sanofi US that gives Acton exclusive US rights to develop and market prescription Nasacort HFA triamcinolone acetonide nasal aerosol for the treatment of nasal allergy symptoms due to seasonal or perennial rhinitis in adults and children 6 years old and … [Read more...] about Acton Pharmaceuticals will develop and market Nasacort HFA in US
Phase 3 results for Merck’s Dulera for the treatment of COPD
Merck has announced results of two Phase 3 clinical studies of Dulera mometasone furoate/formoterol fumarate inhalation aerosol for the treatment of COPD that show statistically significant improvement in lung function in most of the combinations studied and document the incidence of treatment-related adverse events for two dosage strengths. Dulera is approved in the … [Read more...] about Phase 3 results for Merck’s Dulera for the treatment of COPD
CHMP adopts positive recommendation on Bronchitol MAA
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) Pharmaxis has adopted a positive opinion recommending the approval of a marketing authorization for Bronchitol inhaled dry powder mannitol formulation “for the treatment of cystic fibrosis in adults as an add‐on therapy to best standard of care,” says Pharmaxis. Patients with CF who … [Read more...] about CHMP adopts positive recommendation on Bronchitol MAA
Impel gets new funding for development of intranasal delivery
Impel NeuroPharma has announced new funding for development of its Pressurized Olfactory Delivery (POD) device from a variety of sources. The company says that in addition to closing on over a half million dollars of equity investment from "angel investors experienced in the pharmaceutical and medical device industries," it has also entered into collaborations with … [Read more...] about Impel gets new funding for development of intranasal delivery
Hovione and Bend agree to collaborate on inhalation technologies, manufacturing
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
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