According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, for the treatment of asthma in children aged 12 months to 8 years. Other companies with approved ANDAs for budesonide inhalation suspension 0.5 mg/2 mL include Apotex (licensed to Nephron), … [Read more...] about FDA approves Lupin budesonide inhalation suspension
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FDA approves Yupelri revefenacin inhalation solution for COPD
According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application for review in January 2018. The two companies announced in 2015 that they would partner to develop revefenacin, then known as TD-4208, as an … [Read more...] about FDA approves Yupelri revefenacin inhalation solution for COPD
InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The financing round was led by Sofinnova and HealthCap, both new investors along with Deerfield Management. In 2015, InCarda raised … [Read more...] about InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
Trelegy Ellipta gets expanded indication for COPD in Europe
According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate relief of symptoms with a dual bronchodilator. Trelegy Ellipta was approved in Europe in 2017 for COPD patients not … [Read more...] about Trelegy Ellipta gets expanded indication for COPD in Europe
Flutiform okayed for pediatric use in Europe
Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The … [Read more...] about Flutiform okayed for pediatric use in Europe
Insmed CEO Will Lewis becomes chairman of the board as Donald Hayden, Jr steps down
Insmed Incorporated has announced that its Chairman of the Board Donald Hayden, Jr is stepping down as chairman and will be replaced by Insmed President and CEO Will Lewis. Hayden, who served as chairman for 13 years, will continue as a director. Former AstraZeneca CEO David Brennan has been elected as lead independent director. In addition, former Johnson & … [Read more...] about Insmed CEO Will Lewis becomes chairman of the board as Donald Hayden, Jr steps down
FDA approves OTC Primatene Mist for mild asthma
Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals' Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for over the counter sales in the US. The approval is limited to the temporary relief of mild, intermittent asthma symptoms in people aged 12 and over. The new … [Read more...] about FDA approves OTC Primatene Mist for mild asthma
Vectura to develop generic versions of Ellipta DPIs with Hikma
Vectura and Hikma Pharmaceuticals have announced a deal for development and commercialization of generic versions of GSK's Ellipta dry powder inhalers. Hikma will pay Vectura $15 million up front, $5 million at the start of clinical manufacturing for the first product, up to $75 million in development milestones, a percentage of distributable share of net profit on … [Read more...] about Vectura to develop generic versions of Ellipta DPIs with Hikma
Impel NeuroPharma appoints Ellen A. Lubman as Chief Business Officer
Intranasal drug developer Impel NeuroPharma has announced the appointment of former Allergan VP of External Science & Innovation Ellen A. Lubman as Chief Business Officer. Her previous experience also includes stints at Kadmon Pharmaceuticals and Bristol-Myers Squibb. According to the company, Lubman will head up partnering and acquisition activities. In August … [Read more...] about Impel NeuroPharma appoints Ellen A. Lubman as Chief Business Officer
Covis Pharma acquires additional rights to Alvesco, Omnaris, and Zetonna from AstraZeneca
AstraZeneca has announced that Covis Pharma will pay $350 million up front for the rights to market Alvesco ciclesonide MDI and the ciclesonide nasal spray Omnaris and nasal MDI Zetonna outside of the US. The deal also includes up to $21 million in potential payments conditioned on sales over the 4 years beginning in 2019. Covis acquired US rights to Alvesco, Omnaris, … [Read more...] about Covis Pharma acquires additional rights to Alvesco, Omnaris, and Zetonna from AstraZeneca