The Lundquist Institute for Biomedical Innovation (TLI, formerly LABioMed) has licensed a dry powder synthetic lung surfactant formulation to The Bill & Melinda Gates Medical Research Institute (Gates MRI), TLI said. Gates MRI plans to develop the inhalation powder for the treatment of respiratory distress syndrome (RDS) in premature infants in low- and … [Read more...] about The Gates Medical Research Institute to develop dry powder lung surfactant for the treatment of RDS in premature infants
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AIM ImmunoTech initiates Phase 1 trial of intranasal Ampligen for COVID-19
AIM ImmunoTech announced that that the first subjects have been dosed in a Phase 1 safety study of an intranasal formulation of the company’s Ampligen rintatolimod, which the company is developing for the prevention and/or treatment of COVID-19. AIM announced plans for the study in January 2021. According to AIM, in vitro modeling has demonstrated that "clinically … [Read more...] about AIM ImmunoTech initiates Phase 1 trial of intranasal Ampligen for COVID-19
Pneumagen says preclinical study demonstrates the potential of Neumifil for COVID-19
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
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