Pulmocide announced that the FDA has granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for its PC945 inhaled opelconazole for the treatment of invasive pulmonary aspergillosis (IPA). Pulmocide launched in 2013 to develop inhaled anti-fungal therapies, and PC945 is its sole product. According to the company's web site, nebulized … [Read more...] about Pulmocide’s PC945 inhaled opelconazole gets orphan, Fast Track, and QIDP designations
Regulatory
FDA and EMA launch parallel scientific advice pilot program for complex generic products
The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers and nasal sprays. The program began on September 15, 2021 and will continue to accept meeting requests "until a sufficient number of PSA meetings … [Read more...] about FDA and EMA launch parallel scientific advice pilot program for complex generic products
Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance
According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort MDI, includes the ability to capture clinical data in addition to inhaler usage data. Adherium says that the additional capability for monitoring asthma and COPD … [Read more...] about Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance
FDA approves Trudhesa DHE nasal spray for the treatment of migraine
According to Impel NeuroPharma, the FDA has approved the company's Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the application in January 2021. The company said that it plans to launch Trudhesa in the US in early October 2021 and that it will … [Read more...] about FDA approves Trudhesa DHE nasal spray for the treatment of migraine
Aerami’s inhaled imatinib for PAH gets orphan drug designation
The FDA has granted orphan drug designation to Aerami Therapeutics's AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the company said. Aerami initiated a Phase 1 trial of AER– 901 in June 2021, with results expected by the end of the year. In June 2020, Aerami announced a partnership with inhalation CDMO Vectura for … [Read more...] about Aerami’s inhaled imatinib for PAH gets orphan drug designation
FDA pre-approval inspection of Liquidia manufacturing facility has been completed
According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia's facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The company added that it has received notice that the agency will also require a pre-approval inspection of a … [Read more...] about FDA pre-approval inspection of Liquidia manufacturing facility has been completed
Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier
Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 "high-density molecular masking spray" which the company is developing as an anti-viral barrier. According to Virpax, the company now intends to begin clinical development with the goal of submitting an NDA for MMS019 to the FDA's Office of Non-Prescription Drugs. The company … [Read more...] about Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier
FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat
According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin's MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim's Spiriva Respimat tiotropium bromide SMI. Merxin recently announced that it would sponsor doctoral research at the University of Hertfordshire to support development … [Read more...] about FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat
Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis
According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German company AdVita Lifescience, which has been developing inhaled aviptadil for human and veterinary use, with Relief citing the … [Read more...] about Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis
NDA for Levo Therapeutics’ intranasal carbetocin for Prader-Willi syndrome gets priority review designation
Levo Therapeutics announced that the FDA has accepted the company's NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with a decision about approval expected by the end of 2021. LV-101 for PWS was granted Fast Track designation by the FDA in 2019. … [Read more...] about NDA for Levo Therapeutics’ intranasal carbetocin for Prader-Willi syndrome gets priority review designation