Lightlake Therapeutics has provided additional details of recently announced Phase 2 trials of its naloxone nasal spray for binge eating disorder and for bulimia nervosa. Binge eating disorder trials have begun in Helsinki, with 138 patients randomly selected from more than 900 applicants taking either intranasal naloxone or a placebo nasal spray, says the … [Read more...] about Lightlake provides additional details on studies of nasal spray for eating disorders
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MAA for Meda’s Dymista nasal spray filed
Swedish pharmaceutical company Meda has submitted a marketing authorization application for Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe allergic rhinitis and rhinoconjuctivitisto the EMA. An NDA for Dymista was submitted to the FDA in April 2011. Meda CEO Anders Lönner said, "The regulatory filing for … [Read more...] about MAA for Meda’s Dymista nasal spray filed
Alexza submits MAA for Adasuve inhaled loxapine
Alexza Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Adasuve Staccato loxapine for adult patients with schizophrenia or with bipolar disorder. Grupo Ferrer will market Adasuve in Europe if the EMA approves the application. In the US, the company resubmitted an NDA for the product in August 2011 after … [Read more...] about Alexza submits MAA for Adasuve inhaled loxapine
James Ingebrand is new VP and General Manager at 3M DDS
James Vaughan has retired as Vice President and General Manager of 3M Drug Delivery Systems, and the company has announced the appointment of James Ingebrand to replace him. Ingebrand has been with 3M for 27 years and has held a number of positions, including Inhalation Program Manager. According to 3M, “As Vice President and General Manager, Ingebrand will assume … [Read more...] about James Ingebrand is new VP and General Manager at 3M DDS
Novartis warns of delays in US approval process for NVA237 and QVA149
In its third quarter results for 2011, Novartis announced that, "In the US, NVA237 will require additional clinical data to support submission and thus will be delayed." Furthermore, the company warned, "The changes to the US NVA237 program will similarly impact approval timing for QVA149 in the US where additional clinical studies will be required. The QVA149 … [Read more...] about Novartis warns of delays in US approval process for NVA237 and QVA149
New scientific advisory board for Prosonix
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
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