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 trial of PT010 and said that the MDI had been approved in Japan as Breztri Aerosphere. Results from the ETHOS trial … [Read more...] about AstraZeneca gets CRL for PT010
Regulatory
Senzer cannabinoid inhaler gets CE mark
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 "safe and effective delivery of pharmaceutical cannabinoids." The company said that in the UK it planned to supply unlicensed products in the "Specials" … [Read more...] about Senzer cannabinoid inhaler gets CE mark
Generium’s biosimilar of dornase alfa inhalation solution approved in Russia
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 alfa inhalation solution has been approved in the US since 1993 and in Europe since … [Read more...] about Generium’s biosimilar of dornase alfa inhalation solution approved in Russia
US Patent Trial and Appeal Board grants inter partes review of Narcan patent
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 naloxone for the reversal of opioid overdose through 2035, was granted to Lightlake Therapeutics (now Opiant) in December 2015. Adapt … [Read more...] about US Patent Trial and Appeal Board grants inter partes review of Narcan patent
FDA approves Akorn azelastine hydrochloride nasal spray
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 FDA approved Akorn's 0.1% azelastine hydrochloride nasal spray. According to Akorn, the nasal spray is manufactured at the company's facility in Amityville, … [Read more...] about FDA approves Akorn azelastine hydrochloride nasal spray
Merxin says FDA deems its MRX001 blister multidose DPI appropriate for generic Advair
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 Diskus. The company shared this quote from the FDA's response: “After reviewing your controlled correspondence submitted on May 3, 2019, the … [Read more...] about Merxin says FDA deems its MRX001 blister multidose DPI appropriate for generic Advair
Evoke anticipates resubmitting Gimoti NDA by the end of 2019
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 the treatment of diabetic gastroparesis in the fourth quarter of 2019. The company initially submitted the NDA in June 2018; in April 2019, the agency issued a CRL in response to … [Read more...] about Evoke anticipates resubmitting Gimoti NDA by the end of 2019
CHMP issues positive opinion regarding Inbrija
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) in Parkinson's disease patients treated with a levodopa/dopa-decarboxylase inhibitor. The marketing authorization … [Read more...] about CHMP issues positive opinion regarding Inbrija
FDA approves Lilly’s Baqsimi intranasal glucagon (updated)
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 July 2018. The company, which acquired worldwide rights to the nasal glucagon powder from Locemia in 2015, said at the time that it had also … [Read more...] about FDA approves Lilly’s Baqsimi intranasal glucagon (updated)
FDA issues final guidance on postmarket safety reports for combination products
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. The guidance cites several examples of combination product applicants subject to the rule, including "A … [Read more...] about FDA issues final guidance on postmarket safety reports for combination products