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
Regulatory
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
TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims
The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company's Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK Medicines and Healthcare products Regulatory Agency questioned claims regarding Viraleze, prompting the company's … [Read more...] about TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims
UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims
According to Starpharma, LloydsPharmacy has paused sales of Starpharma's Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned "promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorization." The company … [Read more...] about UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims
SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission
SaNOtize Research and Development said that it has gotten approval from Health Canada to move ahead with two Phase 3 trials of its nitric oxide nasal spray for the prevention and treatment of COVID-19. The company also said that it has submitted a new drug submission to the Canadian regulators under a special Health Canada program allowing for rolling review of … [Read more...] about SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission
Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution
Cipla and Glenmark Pharmaceuticals have announced that they have received final approval from the FDA for generic versions of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Cipla said that its product is available immediately. Glenmark noted that the approval is its first for a nebulized product and said that it will … [Read more...] about Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution