Lindal Group announced that the Chinese National Medical Product Administration's (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal's 20 mm male MDI metering valve as active following review. The company said that "the inclusion of the KHFA valve marks significant progress in Lindal headway into the Chinese aerosol dispensing … [Read more...] about CDE activates DMF for Lindal’s KHFA metering valve
Regulatory
Chiesi’s Trimbow triple combination MDI approved for the treatment of asthma in the EU
The European Commission has approved Chiesi's Trimbow extrafine beclometasone / formoterol / glycopyrronium MDI for the treatment of asthma in patients who do not have adequate control with ICS/LABA and who have had at least one exacerbation over the previous year. In October 2019, Chiesi announced positive results from the Phase 3 TRIGGER and TRIMARAN studies of the … [Read more...] about Chiesi’s Trimbow triple combination MDI approved for the treatment of asthma in the EU
Symbicort Turbuhaler approved in China for the treatment of mild asthma
According to AstraZeneca, China's National Medical Products Administration (NMPA) has approved Symbicort Turbuhaler budesonide / formoterol as a reliever inhaler for the treatment of symptoms of mild asthma in patients age 12 and older. Symbicort Turbuhaler was already approved in China for the treatment of moderate-to-severe asthma as a maintenance therapy and as a … [Read more...] about Symbicort Turbuhaler approved in China for the treatment of mild asthma
FDA accepts Impel’s NDA for INP104 intranasal DHE for the treatment of migraines
According to Impel NeuroPharma, the FDA has accepted the company's 5O5(b)(2) NDA for its INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches and has set a PDUFA goal date of September 6, 2021. The agency has also conditionally accepted the trade name "Trudhesa." Impel submitted the NDA for INP104, its first US regulatory … [Read more...] about FDA accepts Impel’s NDA for INP104 intranasal DHE for the treatment of migraines
Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA "resulted in clear guidance on the regulatory requirements" for development of the company's RLS103 dry powder cannabidiol (CBD) for the treatment of panic attacks. The company is pursuing the 505(b)(2) pathway for approval of RLS103. In 2016, MannKind Corporation announced that it had licensed … [Read more...] about Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Ovoca Bio announces resubmission of marketing application for nasal spray for female sexual dysfunction in Russia
Ovoca Bio said that its subsidiary IVIX has resubmitted a marketing application for the company's BP-101 synthetic peptide nasal spray for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women to the Russian Ministry of Health (Minzdrav). The original application was submitted in September 2019, and Minzdrav rejected that application in … [Read more...] about Ovoca Bio announces resubmission of marketing application for nasal spray for female sexual dysfunction in Russia
United Therapeutics to acquire priority review voucher for use with Tyvaso DPI NDA
United Therapeutics announced that it has agreed to pay $105 million for a rare pediatric disease priority review voucher that the company plans to use to get an 8-month FDA review of an NDA for its Tyvaso treprostinil DPI instead of the standard 12-month review. Submission of the NDA for the treatment of pulmonary arterial hypertension and pulmonary hypertension … [Read more...] about United Therapeutics to acquire priority review voucher for use with Tyvaso DPI NDA
FDA places clinical hold on Altimmune’s IND for AdCOVID
The FDA has issued a clinical hold on Altimmune's IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020. According to the company, the FDA requested additional CMC data as well as changes to the protocols, and Altimmune has already responded to the clinical hold letter, which was … [Read more...] about FDA places clinical hold on Altimmune’s IND for AdCOVID
Polyphor to initiate Phase 1 trial of inhaled murepavadin
According to Polyphor, the UK's MHRA has authorized a Phase 1 study of the company's murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients. Initiation of the study, which is partially funded by the European Innovative Medicines Initiative, is expected within weeks. The … [Read more...] about Polyphor to initiate Phase 1 trial of inhaled murepavadin
Oyster Point submits NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease
Oyster Point Pharma has announced its submission of a 505(b)(2) NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease. In May 2020, Oyster Point announced positive results from the the Phase 3 ONSET-2 trial. The company says that data from the Phase 2b ONSET-1, and Phase 2 MYSTIC trials are also used to support the NDA submission. Oyster … [Read more...] about Oyster Point submits NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease