Glenmark Pharmaceuticals announced that the Ministry of Health of the Russian Federation has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis, and the company expects to launch the nasal spray in Russia in the first quarter of fiscal year 2021-22. Glenmark Pharmaceuticals Senior … [Read more...] about Ryaltris nasal spray approved by Russian Ministry of Health
Regulatory
FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune initially submitted the IND in November 2020, and the FDA placed a clinical hold on the application in December 2020 citing the need for changes to the protocols … [Read more...] about FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
EC approves expanded indication for Spravato esketamine nasal spray
According to Janssen, the company's Spravato esketamine nasal spray has been approved by the EC as an add-on to oral antidepressants for adult patients with major depressive disorder (MDD) "as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency." The EMA’s Committee … [Read more...] about EC approves expanded indication for Spravato esketamine nasal spray
CDE activates DMF for Lindal’s KHFA metering valve
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
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