Trimel Pharmaceuticals plans to present data from a recently completed Phase 2 "vibro-tactile stimulation (VTS) study" of its TBS-2 intranasal gel for the treatment of anorgasmia in women to the FDA at a meeting scheduled for November 2011. According to Trimel, in August 2011, it notified the CRO conducting the study that "patient enrolment would be considered … [Read more...] about Trimel concludes Phase 2 study of intranasal gel for female sexual dysfunction
Medical
Teva UK launches generic HFA salmeterol MDI
Teva UK has announced the launch of a generic CFC-free salmeterol metered dose inhaler in the UK; the product is a suspension pMDI that delivers 25 mcg per actuation. The UK granted marketing authorization for the Neovent/Sereflo inhaler for the treatment of asthma and COPD to Neolab Limited in April 2011. Kim Innes, Teva UK Commercial Director, commented, "We are … [Read more...] about Teva UK launches generic HFA salmeterol MDI
Lightlake announces Phase 2 trial of nasal spray for bulimia nervosa
King's College London will be the site of Phase 2 trials of Lightlake Therapeutics's opioid antagonist-based nasal spray treatment for bulimia nervosa, the company has announced. Lightlake currently has Phase 2 trials underway in Finland to demonstrate the effectiveness of its naloxone nasal spray for the treatment of binge eating disorder in overweight and obese … [Read more...] about Lightlake announces Phase 2 trial of nasal spray for bulimia nervosa
Quebec is first Canadian province to offer formulary access to TOBI Podhaler
Novartis Pharmaceuticals Canada has announced that the Québec provincial government will now provide reimbursement for the TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients.The company cites data from Cystic Fibrosis Canada that show about 1,200 cystic fibrosis patients residing in Québec. TOBI Podhaler … [Read more...] about Quebec is first Canadian province to offer formulary access to TOBI Podhaler
Teva offering assistance to Primatene Mist users
Teva Respiratory has announced that it will provide assistance to patients affected by the impending phase out of the OTC Primatene Mist epinephrine inhaler. In addition to providing educational resources, the company says that it will offer financial assistance programs and samples of its ProAir HFA albuterol and QVar HFA beclamethasone metered dose inhalers. Teva … [Read more...] about Teva offering assistance to Primatene Mist users
No safety problems for Nanotherapeutics’ nasal dry powder vaccine in Phase 1 trial
A Phase 1 clinical trial of a novel dry powder intranasal vaccine for prevention of the H5N1 influenza strain demonstrated that the product was well tolerated, and no serious adverse events occurred, according to developer Nanotherapeutics. the GelVac nasal dry powder H5N1 vaccine is delivered by a disposable single-use positive pressure intranasal inhaler that uses … [Read more...] about No safety problems for Nanotherapeutics’ nasal dry powder vaccine in Phase 1 trial
Effort to study COPD prevalence in Sub-Saharan African launched
The International Primary Care Respiratory Group (IPCRG) has launched a petition in support of its Fresh Air Uganda study in response to what it says is a growing threat in the region, with COPD expected to surpass HIV/AIDs as the third-leading cause of death in Africa by 2025. The epidemiological study in rural Uganda will involve 600 people over the age of 30, … [Read more...] about Effort to study COPD prevalence in Sub-Saharan African launched
Pulmatrix presents data from preclinical studies of its inhaled calcium salts
Massachusetts biotech company Pulmatrix presented data from two studies of its Pulmatrix presents data from preclinical studies of its lead product, PUR118, an inhaled cationic airway lining modulator (iCALM) for the treatment of respiratory diseases in oral and poster sessions at the 2011 European Respiratory Society (ERS) conference. The data show that PUR118 … [Read more...] about Pulmatrix presents data from preclinical studies of its inhaled calcium salts
Novartis has filed MAA for Seebri Breezhaler in Europe
Novartis has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its NVA237 glycopyrronium bromide dry powder inhaler, which will be called the Seebri Breezhaler. The MAA once-daily long-acting antimuscarinic (LAMA) triggered a $5 million milestone payment to Sosei, which co-developed the product with Vectura and licensed it … [Read more...] about Novartis has filed MAA for Seebri Breezhaler in Europe
Amirall presents full data for Phase 3 ATTAIN study of aclidinium bromide at ERS
Almirall has presented a number of posters at the 2011 Annual Congress of the European Respiratory Society (ERS), including, for the first time, full data from the six-month Phase 3 ATTAIN study of its aclidinium bromide dry powder inhaler for the treatment of moderate-to-severe COPD. The data show that twice-daily doses of either 200 μg or 400 μg of aclidinium … [Read more...] about Amirall presents full data for Phase 3 ATTAIN study of aclidinium bromide at ERS