US generics company Mylan Inc. has obtained worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair Diskus and Seretide Diskus products for asthma and COPD using Pfizer's proprietary dry powder inhalation technology. Pfizer will also allow Mylan to develop and commercialize other DPI products using the … [Read more...] about Mylan gets Pfizer’s respiratory delivery platform, acquires global rights to generic Diskus products
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Discovery Labs announces progress on inhaled therapies
Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new product, Afectair, which it calls "a series of proprietary ventilator circuit/patient interface connectors and related componentry" that "simplifies the … [Read more...] about Discovery Labs announces progress on inhaled therapies
Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis
Sunovion is presenting results from a 26-week double-blind, randomized Phase 3 study of ciclesonide HFA nasal aerosol involving more than 1,100 patients with perennial allergic rhinitis (PAR) that showed statistically significant improvement in nasal symptoms for ciclesonide compared to placebo. The study demonstrated positive results for both a 74 mcg dose and a 148 … [Read more...] about Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis
Catalent joins IPAC-RS
CRO Catalent Pharma Solutions has joined the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), a consortium of companies involved in the development, manufacture, and marketing of OINDPs, whose mission is "to advance scientifically driven approaches to enhancing product quality of inhaled and intranasal drug products." Other IPAC-RS … [Read more...] about Catalent joins IPAC-RS
US Senate votes down bill that would have banned enforcement of the CFC inhaler phaseout
US Senator Jim DeMint, a Republican from South Carolina, failed to persuade the US Senate to prohibit the use of tax dollars for enforcement of the FDA ban on the CFC-propelled OTC epinephrine inhaler Primatene Mist. The Senate voted 54-44 against DeMint's bill. DeMint expressed outrage at the outcome of the vote: “Fifty-four Senators voted to appease extreme … [Read more...] about US Senate votes down bill that would have banned enforcement of the CFC inhaler phaseout
Lightlake provides additional details on studies of nasal spray for eating disorders
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
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