Regulatory
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Medical Developments International (MVP) has announced that Health Canada has accepted its submission for the Penthrox methoxyflurane inhaler, triggering a $250,000 Canadian milestone payment to MVP from Purdue Pharma Canada. In September 2016, MVP announced… Read more . . .
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According to Novartis, the FDA has accepted Sandoz’s abbreviated new drug application for its generic version of the Advair Discus (Seretide Accuhaler) fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD. The company acquired… Read more . . .
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Pharmaxis has announced that its pivotal Phase 3 trial of Bronchitol mannitol DPI in adult patients with cystic fibrosis met its primary endpoint of change in FEV1 from baseline over the 26-week treatment period; however… Read more . . .
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According to Sunovion, the FDA has issued a complete response letter (CRL) for its NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD. Sunovion submitted the NDA for SUN-101/eFlow in July 2016, and… Read more . . .
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Chiesi Group has announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s MAA for Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI. Chiesi has applied to… Read more . . .
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Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The company… Read more . . .
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Aptar Pharma has announced that its partner Takeda Pharmaceuticals has received approval from the EMA to market a multidose version of its Instanyl fentanyl nasal spray that includes Aptar’s e-Lockout integrated electronic lockout device. According… Read more . . .
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According to Vectura, its partner Hikma Pharmaceuticals has received a complete response letter from the FDA to its ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. Vectura said that the… Read more . . .
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The IMPALA Phase 2/3 trial for Savara’s Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission,… Read more . . .
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According to Evoke Pharma, the company has reached an agreement with the FDA on design of a PK trial for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The company said that… Read more . . .
Upcoming Events
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland