The Japanese Ministry of Health, Labour and Welfare has approved Insmed's Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have not been successfully treated with a multi-drug regimen, and the company says that it expects to launch Arikayce … [Read more...] about Insmed’s Arikayce inhalation suspension approved in Japan for the treatment of NTM lung disease caused by MAC
Regulatory
FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Meissa Vaccines announced that the FDA has cleared the company's IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy … [Read more...] about FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose and by more than 99% within 72 hours. In addition, clearance of the SARS-CoV-2 virus was 16 times faster for patients using NONS than for those given a placebo. Based … [Read more...] about SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic
The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva Drug Delivery), for patent infringement after Mylan filed an ANDA for a generic version of Symbicort. The judge concluded that "Mylan … [Read more...] about Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic
FDA clears Sorrento’s IND for Phase 1 trial of STI-2099 intranasal antibody against COVID-19
Sorrento Therapeutics said that the FDA has cleared its IND for a Phase 1 study of STI-2099 intranasal neutralizing antibody (CoviDrops) in healthy volunteers and in patients with mild COVID-19. The company said that it plans to study STI-2099 by itself or combined with an IV formulation of the antibody. In October 2020, Sorrento announced that STI-2099 reduced the … [Read more...] about FDA clears Sorrento’s IND for Phase 1 trial of STI-2099 intranasal antibody against COVID-19
FDA accepts Oyster Point’s NDA for OC-01 varenicline nasal spray for dry eye disease
According to Oyster Point Pharma, the FDA has accepted the company's NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease and has set a PDUFA goal date of October 17, 2021. The company said that the FDA has no plans for an advisory committee meeting in regards to the application. Oyster Point submitted the 505(b)(2) NDA in December 2020. … [Read more...] about FDA accepts Oyster Point’s NDA for OC-01 varenicline nasal spray for dry eye disease
FDA approves Cipla’s sumatriptan nasal spray
Cipla Limited announced that the FDA has issued final approval of an ANDA for the company's generic version of GSK's Imitrex 20 mg sumatriptan nasal spray. Cipla's sumatriptan nasal spray is an AB-rated generic. Imitrex nasal spray was first approved by the FDA in 5 mg, 10 mg, and 20 mg doses in 1997. Lannett’s ANDA for a generic version of the 5 and 20 mg dose … [Read more...] about FDA approves Cipla’s sumatriptan nasal spray
Ryaltris nasal spray approved by Russian Ministry of Health
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
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