According to Impel NeuroPharma, the FDA has approved the company's Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the application in January 2021. The company said that it plans to launch Trudhesa in the US in early October 2021 and that it will … [Read more...] about FDA approves Trudhesa DHE nasal spray for the treatment of migraine
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Nocion Therapeutics announces Phase 2a trial of inhaled NTX-1175 charged sodium channel blocker for chronic cough
Nocion Therapeutics has dosed the first 10 subjects in a Phase 2a study of NOC-100, an inhaled formulation of its NTX-1175, a charged sodium channel blocker, the company said. Nocion is developing NTX-1175 for the treatment of chronic and acute cough, including cough resulting from COVID-19. According to the company, a Phase 1 study of inhaled NTX-1175 was completed … [Read more...] about Nocion Therapeutics announces Phase 2a trial of inhaled NTX-1175 charged sodium channel blocker for chronic cough
ARS raises $55 million for potential launch of its Neffy intranasal epinephrine
ARS Pharmaceuticals said that it has raised $55 million in a Series D financing round to support approval and potential launch of its Neffy (ARS-1) intranasal epinephrine for the treatment of anaphylaxis as well as studies of the nasal spray for other indications. ARS submitted an MAA for Neffy to the EMA in November 2020. The FDA granted Fast Track designation … [Read more...] about ARS raises $55 million for potential launch of its Neffy intranasal epinephrine
Medicon Valley Inhalation Symposium postponed
The Medicon Valley Inhalation Consortium (MVIC) has announced that the 2021 Medicon Valley Inhalation Symposium (MVIS), which was to take place on October 13-14 in Lund, Sweden, has been postponed indefinitely. The MVIC training session scheduled for October 11-12 in Lund will go ahead. MVIC called the postponement, "Very unfortunate, frustrating and even … [Read more...] about Medicon Valley Inhalation Symposium postponed
Vivera gets US patents for Zicoh smart inhaler
Within one week in August, Vivera Pharmaceuticals has announced the issuance of two US patents covering its Zicoh smart inhaler technology. The first is US Patent No. 11,083,850 ("Secure smart dosing system with automated delivery, measurement, and management") and the second is US Patent No. 11,090,449 ("Smart inhaler device with automated dose delivery, measurement, … [Read more...] about Vivera gets US patents for Zicoh smart inhaler
Aerami’s inhaled imatinib for PAH gets orphan drug designation
The FDA has granted orphan drug designation to Aerami Therapeutics's AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the company said. Aerami initiated a Phase 1 trial of AER– 901 in June 2021, with results expected by the end of the year. In June 2020, Aerami announced a partnership with inhalation CDMO Vectura for … [Read more...] about Aerami’s inhaled imatinib for PAH gets orphan drug designation
Lupin launches Luforbec beclometasone/formoterol MDI in the UK
Lupin Healthcare has announced the launch of the Luforbec beclometasone/formoterol MDI in the UK. The generic version of Chiesi’s Fostair MDI was approved by the MHRA for the treatment of asthma and COPD in June 2021. According to Lupin, the Luforbec inhaler will be manufactured at the company's facilities in the US and India. The company cited UK prescribing data … [Read more...] about Lupin launches Luforbec beclometasone/formoterol MDI in the UK
Crystec and SignalRx partner on development of inhaled P13K-BRD4 inhibitor
Particle engineering company Crystec has announced a new partnership with SignalRx Pharmaceuticals for development of an inhaled dry powder formulation of SignalRx's SF2523 PI3K-BRD4 inhibitor for the treatment of pulmonary fibrosis, lung cancer, and COVID-19. The project is supported by Swiss life sciences investment company ADYA Consulting. According to the … [Read more...] about Crystec and SignalRx partner on development of inhaled P13K-BRD4 inhibitor
FDA pre-approval inspection of Liquidia manufacturing facility has been completed
According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia's facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The company added that it has received notice that the agency will also require a pre-approval inspection of a … [Read more...] about FDA pre-approval inspection of Liquidia manufacturing facility has been completed
Positive Phase 1 results for Receptor Life Sciences’ RLS103 CBD DPI
Receptor Life Sciences (RLS) has published data from a Phase 1 PK trial of its RLS103 dry powder cannabidiol (CBD) in the Journal of Pharmaceutical Sciences demonstrating significantly greater bioavailability for the inhaled CBD than for Epidiolex oral CBD solution. RLS announced completion of its pre-IND meeting with the FDA in January 2021. Receptor licensed … [Read more...] about Positive Phase 1 results for Receptor Life Sciences’ RLS103 CBD DPI