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Medical

Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories

Vectura Group has confirmed that its US partner for the VR315 fluticasone/salmeterol DPI and the VR506 generic fluticasone propionate DPI is Boehringer Ingelheim subsidiary Roxane Laboratories. The company is partnered with Sandoz on VR315 in the rest of the world. When Vectura announced the VR315 US licensing deal in August 2011, it referred to its partner as "a … [Read more...] about Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories

Cipla launches mobile app for management of asthma in India

Cipla has announced the launch of a mobile app called “My Breathefree,” which is intended to serve as a "virtual caregiver" for asthma patients in India. The app includes video demonstrations of correct use for various types of inhalers in 10 languages, as well as dose reminders, tracking tools for peak expiratory flow rate, a "trigger map," and other resources from … [Read more...] about Cipla launches mobile app for management of asthma in India

Discovery Labs initiates Phase 2b trial of Aerosurf

Discovery Laboratories has announced the initiation of a Phase 2b trial of Aerosurf aerosolized KL4 surfactant to treat respiratory distress syndrome (RDS) in premature infants. The trial, which is expected to enroll up to 250 patients will compare outcomes for infants receiving Aerosurf plus non-invasive nasal continuous positive airway pressure (nCPAP) to outcomes … [Read more...] about Discovery Labs initiates Phase 2b trial of Aerosurf

Alexza announces interim results from Phase 2a study of AZ-002

Alexza Pharmaceuticals has announced interim results from a Phase 2a study of AZ-002 inhaled alprazolam in epilepsy patients. Dose-related decreases in mean standardized photosensivity range (SPR), the study's primary endpoint, were noted 2 minutes post inhalation for 2 of the 3 doses tested, the company said. According to Alexza, AZ-002 was also well tolerated with … [Read more...] about Alexza announces interim results from Phase 2a study of AZ-002

Study finds intranasal glucagon effective for treatment of insulin-induced hypoglycemia

A study published online in the journal Diabetes Care on December 17, 2015 demonstrated non-inferiority of intranasal glucagon to intramuscular glucagon for the treatment of insulin-induced hypoglycemia in type 1 diabetes patients. The study found that intranasal glucagon successfully raised plasma glucose to the target level within 30 minutes after dosing in 98.7% of … [Read more...] about Study finds intranasal glucagon effective for treatment of insulin-induced hypoglycemia

Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway

Enrollment has begun for a Phase 1 clinical study of Acorda Therapeutics' CVT-427 zolmitriptan DPI for the treatment of migraines, the company said. The single ascending dose study, which is expected to enroll 32 healthy adults, will assess the safety and tolerability of four doses of CVT-427 and will compare the pharmacokinetics of the inhaled drug to the … [Read more...] about Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway

Sumatriptan nasal spray shortage expected to last until February 2016

According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic sumatriptan nasal spray distributed by Sandoz … [Read more...] about Sumatriptan nasal spray shortage expected to last until February 2016

Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair

Novartis today has announced that the Phase 3 FLAME study demonstrated that the Utibron Neohaler (Ultibro Breezhaler) indacaterol/glycopyrronium DPI reduced the rate of COPD exacerbations more effectively than the Advair (Seretide) fluticasone/salmeterol DPI over a 52-week period. FLAME involved over 3,360 COPD patients in 43 countries and was designed to demonstrate … [Read more...] about Phase 3 study shows indacaterol/glycopyrronium reduces COPD exacerbations better than Advair

Positive top-line results from several Teva Phase 3 DPI studies

Teva Pharmaceutical Industries has announced top-line results from three Phase 3 clinical studies of its generic fluticasone propionate/salmeterol DPI and a fluticasone propionate monotherapy DPI for the treatment of asthma. The company said that all of the studies met their primary endpoints and that it plans to submit regulatory applications to the FDA for both … [Read more...] about Positive top-line results from several Teva Phase 3 DPI studies

Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016

Turing Pharmaceuticals, which is the subject of several investigations into its pricing strategies, has said that it plans to begin a Phase 1 trial of its TUR-002 intranasal ketamine in the first quarter of 2016. The company said that is developing TUR-002 for both post-traumatic stress disorder (PTSD) and major depressive disorder. Turing CEO Martin Shkreli said, … [Read more...] about Turing Pharmaceuticals says it will initiate a Phase 1 trial of intranasal ketamine in early 2016

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