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
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Skyepharma partners with Mundipharma on triple combination MDI
Skyepharma has announced a partnership agreement with Mundipharma for global development and commercialization of Skyepharma's SKP-2076 ICS/LABA/LAMA fixed dose combination MDI. Mundipharma, which already markets Skyepharma's Flutiform fluticasone propionate/formoterol fumarate MDI in Europe and a number of other markets, will pay a non-refundable option fee in the … [Read more...] about Skyepharma partners with Mundipharma on triple combination MDI
GSK recalls almost 129,000 Ventolin inhalers
GlaxoSmithKline has recalled two lots of Ventolin HFA metered dose inhalers totaling 128,704 inhalers, according to an FDA enforcement report. The company initiated the voluntary recall on December 3, 2015 due to concerns about insufficient propellant in the cans for delivery of all 200 doses. According to a copy of the recall letter posted by a distributor, the … [Read more...] about GSK recalls almost 129,000 Ventolin inhalers
Neurelis gets orphan drug designation for intranasal diazepam
The FDA has granted orphan drug designation to Neurelis's lead product, NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients, the company said. Biotie paid $1 million for an option to buy Neurelis and rights to the product in 2013 but returned the rights in July 2014. Neurelis President and CEO Craig C. Chambliss commented, … [Read more...] about Neurelis gets orphan drug designation for intranasal diazepam
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
Turing Pharmaceuticals names Ron Tilles interim CEO
After the arrest of its CEO, Martin Shkreli, on securities fraud charges, Turing Pharmaceuticals has announced Shkreli's resignation and the appointment of Ron Tilles as Interim CEO. Tilles has chaired Turing's board of directors since the company's inception. Turing launched in 2014 after Shkreli's former employer Retrophin ousted him over alleged stock trading … [Read more...] about Turing Pharmaceuticals names Ron Tilles interim CEO
AstraZeneca to acquire Takeda’s respiratory business
AstraZeneca has announced that it will acquire Takeda's respiratory line for $575 million. According to the company, about 200 Takeda employees will transfer to AstraZeneca as part of the deal. The company is citing the acquisition of roflumilast (Daliresp/Daxas), an oral PDE4 inhibitor for the treatment of COPD, as a highlight of the deal, but it is also … [Read more...] about AstraZeneca to acquire Takeda’s respiratory business
Turing Pharmaceuticals CEO Martin Shkreli arrested for securities fraud
Turing Pharmaceuticals CEO Martin Shkreli has been arrested by the Federal Bureau of Investigations for securities fraud involving illegal stock transactions when he was CEO of Retrophin Pharmaceuticals. Retrophin fired Shkreli in September 2014 and later divested its intranasal oxytocin and ketamine products to his new company, Turing. Retrophin has since sued … [Read more...] about Turing Pharmaceuticals CEO Martin Shkreli arrested for securities fraud
Capsugel acquires Xcelience and Powdersize
Capsugel has announced that it will acquire CDMO Xcelience and micronization services provider Powdersize in order to "enhance Capsugel’s position as a leading provider of innovative dosage forms and solutions to healthcare customers around the world." Both companies will become part of Capsugel's Dosage Form Solutions business unit. Terms of the deal were … [Read more...] about Capsugel acquires Xcelience and Powdersize