According to Pneumagen, its Neumifil carbohydrate binding module (mCBM), which it is developing as a nasal spray for the prevention and treatment of respiratory infections, significantly reduced symptoms and weight loss in a hamster model of COVID-19. Researchers also found that Neumifill demonstrated high binding affinity for the ACE2 receptor and for the SARS-CoV-2 … [Read more...] about Pneumagen says preclinical study demonstrates the potential of Neumifil for COVID-19
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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
Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
Pulmatrix has announced plans for clinical development of PUR3100, an iSPERSE dry powder formulation of dihydroergotamine (DHE) for the treatment of migraine, after a PK study in dogs showed exposure kinetics similar to those of the Levadex (MAP0004, Semprana) DHE MDI. The company also provided updates on its development programs for Pulmazole and PUR1800 and said … [Read more...] about Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
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
Impel NeuroPharma announces management appointments to support potential launch of its Trudhesa intranasal DHE
Impel NeuroPharma has named Leonard S. Paolillo as Chief Commercial Officer and Gerald F. Penn as VP, Market Access and Trade in anticipation of the launch of Trudhesa intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches if approved by the FDA. Impel submitted an NDA for Trudhesa (INP104)in November 2020, and the FDA has set a PDUFA goal … [Read more...] about Impel NeuroPharma announces management appointments to support potential launch of its Trudhesa intranasal DHE
Copley announces updates to its OINDP testing equipment range
OINDP testing specialist Copley Scientific has announced upgrades to the company's inhaler testing equipment range, including new products such as the Inhaler Testing Workstation (ITW) and updates to its TPK critical flow controllers, BAC 2100 breath actuated controllers, and BRS breathing simulators. The company has also updated its comprehensive inhaler testing … [Read more...] about Copley announces updates to its OINDP testing equipment range
Positive Phase 1 results for Atossa’s AT-301 nasal spray
Atossa Therapeutics announced that a two-week Phase 1 study evaluating the safety of two dose levels of the company's AT-301 nasal spray in healthy volunteers demonstrated that the nasal spray was safe and well tolerated. The company announced in August 2020 that it had received approval for the Phase 1 trial of AT-301, which it is developing as an at-home treatment … [Read more...] about Positive Phase 1 results for Atossa’s AT-301 nasal spray
The Year of the Aerosol Scientist
Reflections by Philip Kuehl and Jacob McDonald, Lovelace Biomedical What a year! 2020 was the year when those of us in aerosol science were forced to stop compartmentalizing. It was the year that we could no longer keep our work lives separate from our personal lives – our work spilled over into our personal lives on a daily basis. 2020 was the year that the … [Read more...] about The Year of the Aerosol Scientist