Regulatory
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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.… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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.… Read more . . .
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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… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA