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Regulatory

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

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

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