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
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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
Insys Therapeutics announces management changes
Insys Therapeutics has announced the resignation of President and CEO Michael L. Babich and the appointment of John N. Kapoor to those positions, effective November 4, 2015. The company also named Daniel Brennan as Executive VP and COO. The effective date of the CEO change is the same day that CNBC aired an investigative report about Insys, which is under … [Read more...] about Insys Therapeutics announces management changes
Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD. The decision to switch course came after meeting with the FDA … [Read more...] about Acerus changes course on Tefina intranasal testosterone gel, says Endo “de-priotizing” Natesto
Alexza to reacquire US rights to Adasuve from Teva
Alexza Pharmaceuticals has announced that it plans to reacquire US rights for Adasuve loxapine inhalation powder from Teva Pharmaceuticals USA by January 1, 2016. According to the company, "Alexza and Teva are working on a transition agreement to continue product availability to patients and health care providers after the return of the rights to Alexza." Adasuve … [Read more...] about Alexza to reacquire US rights to Adasuve from Teva
AstraZeneca launches Duaklir Genuair in Canada
AstraZeneca Canada has announced the availability of the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI in Canada for the treatment of COPD. Health Canada issued a Notice of Compliance for Duaklir Genuair on April 2, 2015. AstraZeneca acquired Canadian rights to Duaklir Genuair from Actavis in February 2015. In Europe, the inhaler was approved for the … [Read more...] about AstraZeneca launches Duaklir Genuair in Canada
Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe
Glenmark Pharmaceuticals announced that it has obtained semi-exclusive rights develop and market a generic fluticasone/salmeterol DPI in 15 European countries as part of an agreement with Polish pharmaceutical company Celon Pharma. The countries covered in the deal include the UK, Germany, Norway, Sweden, and Romania. Glenmark will pay an undisclosed amount up front, … [Read more...] about Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe