Sanofi will return development and commercialization rights for Afrezza inhaled insulin to MannKind after disapponting sales, and MannKind says that it is considering strategic options for the product. Afrezza was approved by the FDA in June 2014. According to MannKind, The parties will promptly commence transition discussions in order to effect a smooth and … [Read more...] about Sanofi to return Afrezza rights to MannKind
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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
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
Teva to market Sprix nasal spray in Israel
Teva has acquired exclusive marketing and commercialization rights to Egalet Corporation's Sprix ketorolac tromethamine nasal spray in Israel, Gaza and the West Bank, Egalet has announced. Sprix nasal spray is used for the short-term treatment of moderate-to-severe pain in adults. Financial terms were undisclosed but include an upfront payment, sales-based milestone … [Read more...] about Teva to market Sprix nasal spray in Israel
RODES Inc licenses Captisol-enabled intranasal budesonide/azelastine from Ligand
RODES, Inc. and Ligand Pharmaceuticals have announced global license and supply agreements for three products in development using Ligand's Captisol formulation technology, including intranasal budesonide/azelastine for the treatment of allergic rhinitis. RODES will pay all development and commercial costs, make milestone payments, and pay royalties of 8% - 11% on … [Read more...] about RODES Inc licenses Captisol-enabled intranasal budesonide/azelastine from Ligand
InCarda Therapeutics establishes Australian subsidiary
US inhaled drug developer InCarda Therapeutics has launched a subsidiary business in Australia in preparation for its first clinical trial, which is scheduled for the first half of 2016, the company said. According to InCarda, it is already manufacturing and testing formulations in Australia and has entered into agreements with Australian CROs. In April 2015, … [Read more...] about InCarda Therapeutics establishes Australian subsidiary
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
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