OINDPnews


Copley Scientific banner

News

AstraZeneca announces plans for “next-generation inhaler” as part of “Ambition Zero Carbon” program

AstraZeneca has announced a commitment to launching a "next-generation" MDI with minimal global warming potential (GWP) propellants by 2025 as part of its $1 billion "Ambition Zero Carbon" program. The new program, which was announced at the World Economic Forum meeting in Davos, Switzerland, aims for zero carbon emissions by 2025 and a carbon negative value chain by … [Read more...] about AstraZeneca announces plans for “next-generation inhaler” as part of “Ambition Zero Carbon” program

Impel NeuroPharma appoints Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise

Impel NeuroPharma has announced the appointment of Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise. Aurora will handle medical affairs strategy for Impel's INP104 intranasal intranasal dihydroergotamine (DHE) for the treatment of acute migraine. The company announced the initiation of the Phase 3 STOP-301 study of INP104 in August 2018. Aurora was … [Read more...] about Impel NeuroPharma appoints Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise

Virpax to develop intranasal enkephalin formulation for the treatment of PTSD

Virpax Pharmaceuticals announced that it has acquired exclusive global rights from Nanomerics Ltd. for the use of molecular envelope technology (MET) for delivery of an intranasal formulation of enkephalin for the treatment of PTSD. The company says that PES200 will be delivered via a cartridge-based, pressurized nasal delivery device, presumably the Naltos dry … [Read more...] about Virpax to develop intranasal enkephalin formulation for the treatment of PTSD

Janssen submits type II variation application for Spravato

Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder (MDD) in patients who have active suicidal ideation with intent. Spravato was approved in Europe in December 2019 for the treatment of … [Read more...] about Janssen submits type II variation application for Spravato

Positive results for Phase 2b trial of nebulized ensifentrine as add-on to tiotropium

Verona Pharma said that a Phase 2b dose-ranging study of its RPL554 nebulized ensifentrine as an add on to tiotropium for the treatment of COPD met its primary endpoint at all doses tested. The company had announced initiation of the study in May 2019. The 4 week study, which enrolled 416 moderate-to-severe COPD patients, compared 0.375 mg, 0.75 mg, 1.5 mg, and … [Read more...] about Positive results for Phase 2b trial of nebulized ensifentrine as add-on to tiotropium

FDA approves Valtoco diazepam nasal spray for the treatment of seizure clusters

The FDA has approved Neurelis's Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in September 2018. Valtoco, which was formerly known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in … [Read more...] about FDA approves Valtoco diazepam nasal spray for the treatment of seizure clusters

Phase 2 study of Oyster Point’s OC-01 nasal spray for dry eye disease meets primary endpoint

According to Oyster Point Pharma, the Phase 2 MYSTIC study of its OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear production at Day 84 compared to control as measured by Schirmer's score. Both doses tested met that endpoint, with a 1.2 mg/ml dose achieving an 11.0 mm mean change … [Read more...] about Phase 2 study of Oyster Point’s OC-01 nasal spray for dry eye disease meets primary endpoint