Regulatory

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 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 . . .

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 . . .

The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in… Read more . . .

The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016.… Read more . . .

Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency’s August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve… Read more . . .