Approximately 550 OINDP specialists attended RDD 2018 in Tucson, Arizona, where much of the interest centered around regulatory issues, especially in light of the FDA's recent release of a revised draft guidance on MDI and DPI quality considerations. The RDD organizers capitalized on the release, adding a late breaking presentation by the FDA's Rik Lostritto on … [Read more...] about Highlights from RDD 2018
News
JDRF awards grant for intranasal insulin study
Leading diabetes research funder JDRF has awarded a 2-year $525,000 grant to International Diabetes Center (IDC) to support a study of intranasal insulin in Type 1 diabetes patients with hypoglycemia unawareness, the first time that JDRF has funded intranasal insulin research. JDRF has previously funded a study of Afrezza inhaled insulin used with an artificial … [Read more...] about JDRF awards grant for intranasal insulin study
Avadel launches Noctiva desmopressin nasal spray
Avadel Pharmaceuticals has announced the launch of Noctiva desmopressin nasal spray for the treatment of nocturia due to nocturnal polyuria (overproduction of urine at night) in adults. Avadel acquired US and Canadian rights to Noctiva from Serenity Pharmaceuticals in September 2017 for $50 million up front, plus milestone payments and royalties. A $20 million … [Read more...] about Avadel launches Noctiva desmopressin nasal spray
Adherium announces collaboration with Vitalus Health
Smartinhaler maker Adherium has announced a collaboration with pulmonary disease management provider Vitalus Health for promotion of Adherium's inhaler monitoring technology to COPD patients in the southwest US. In September 2017, Adherium's SmartTouch sensor received 510(k) clearance from the FDA for use with the Symbicort inhaler, and in March 2018, the … [Read more...] about Adherium announces collaboration with Vitalus Health
Clement Clarke launches new inhaler training app
Clement Clarke International has announced the availability of a new smartphone app called the Trainhaler Buddy for use with its Trainhaler device to teach patients correct inhaler use technique. The Trainhaler Buddy app uses animations to provide visual feedback, reinforcing audio feedback provided by the whistling mouthpiece on the Trainhaler device, as the patient … [Read more...] about Clement Clarke launches new inhaler training app
Impax to sell azelastine and olopatadine nasal sprays to Perrigo for merger with Amneal
The US Federal Trade Commission (FTC) is requiring Impax to divest several products in order to complete a planned merger with Amneal that the companies announced in October 2017. To satisfy the FTC requirements, Impax will sell its azelastine and olopatadine nasal sprays to Perrigo, subject to completion of the merger. Impax and Perrigo had partnered on both … [Read more...] about Impax to sell azelastine and olopatadine nasal sprays to Perrigo for merger with Amneal
Mundipharma’s k-haler wins design awards
Mundipharma's k-haler breath-activated metered dose inhaler has won two platinum A’ Design Awards in the ‘Scientific Instruments, Medical Devices and Research Equipment Design’ and ‘Ease of Use and Universal Design’ categories. In October 2017, the company's Flutiform k-haler received marketing approval for the treatment of asthma through the European … [Read more...] about Mundipharma’s k-haler wins design awards
FDA no longer requiring REMS communication plan for Afrezza inhaled insulin
MannKind Corporation has announced that FDA is no longer requiring a Risk Evaluation and Mitigation Strategy (REMS) communication plan for Afrezza inhaled insulin. Afrezza was approved in the US in June 2014, with the FDA requiring a boxed warning about bronchospasm in asthma and COPD patients and several post-marketing studies. According to the company, the REMS … [Read more...] about FDA no longer requiring REMS communication plan for Afrezza inhaled insulin
The FDA approves expanded indication for Trelegy Ellipta
According to GlaxoSmithKline and Innoviva, the FDA has approved an expanded indication for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, allowing the use of Trelegy Ellipta for COPD patients with airflow limitation or with acutely worsening respiratory symptoms. GSK filed an sNDA for Trelegy Ellipta in November 2017 based on data from the … [Read more...] about The FDA approves expanded indication for Trelegy Ellipta
US company licenses cannabis pMDI
A US company called Honu Xpress says that it has acquired a license for the Mystabis cannabis MDI which it claims "provides pressurized metered-doses of cannabis oil directly to the lung's capillaries with little to no exhale" and up to 95% bioavailabilty. The company said that it plans to sell the inhaler in US and foreign markets except for Canada and Australia … [Read more...] about US company licenses cannabis pMDI