Regulatory
-
Savara said that the FDA provided a written response after a Type C meeting regarding the company’s planned biologics license application (BLA) submission for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment… Read more . . .
-
AstraZeneca Canada has announced today that Health Canada has approved the use of Symbicort Turbuhaler budesonide/formoterol DPI as an anti-inflammatory reliever for the treatment of mild persistent asthma. According to the company, the expanded use was based on… Read more . . .
-
According to AstraZeneca, the FDA has issued a complete response letter to the company’s NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS… Read more . . .
-
Senzer Pharmaceuticals said that it plans to launch its cannabinoid inhaler in the UK and elsewhere in Europe by the end of 2019 now that the device has received Class IIa Medical Device approval for the… Read more . . .
-
Russian biopharmaceutical company Generium JSC’s dornase alfa biosimilar inhalation solution has received marketing approval from Russian regulators for the treatment of cystic fibrosis, according to its partner Selexis, which developed the cell line. Genentech’s Pulmozyme dornase… Read more . . .
-
The US Patent Trial and Appeal Board (PTAB) has instituted an inter partes review of US Patent No. 9,211,253, “Nasal drug products and methods of their use.” That patent, which covers Opiant Pharmaceutical’s Narcan intranasal… Read more . . .
-
The FDA has approved Akorn’s ANDA for its azelastine hydrochloride nasal spray, 0.15%, for the treatment of allergic and perennial rhinitis in patients 6 years old and older, the company said. In May 2019, the… Read more . . .
-
According to generic inhalation device developer Merxin, the FDA has reviewed data for the company’s MRX001 blister multidose DPI and suggested that the agency would accept the MRX001 as an AB rated substitutable version of… Read more . . .
-
Evoke Pharma said that it has received minutes from a July 25, 2019 Type A meeting with the FDA and that the company now plans to resubmit its NDA for Gimoti metoclopramide nasal spray for… Read more . . .
-
According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods)… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
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