OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for general sales as a nicotine replacement therapy. According to the Ayrtons web site, the company "has completely redeveloped the original … [Read more...] about MHRA approves Type II variation to the Voke nicotine inhaler marketing authorization
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MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving an HbA1c level of less than 7% at 17 weeks compared to 17% of the usual care group. The company, which announced some data from the … [Read more...] about MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
Ritedose increases production capacity for inhalation products
CDMO Ritedose Corporation announced that it has added blow-fill-seal (BFS) capacity to its manufacturing facility in Columbia, SC, USA that will allow it to manufacture an additional 180 million unit doses of opthalmic and respiratory solutions. In addition to contract development and manufacturing, Ritedose manufactures its own generic inhalation solutions, including … [Read more...] about Ritedose increases production capacity for inhalation products
Proveris launches new Vereo NSx+SWC system for DDU testing of nasal sprays
Proveris Scientific has announced the official launch of the Vereo NSx+SWC (spray, weigh, and collect) nasal spray system, which it recently exhibited at RDD 2024 and which it calls "a pivotal advancement in product development and quality control workflows" with "walkaway automated functionality." The new system combines Proveris's Vereo NSx+ actuator technology with … [Read more...] about Proveris launches new Vereo NSx+SWC system for DDU testing of nasal sprays
Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company's AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint of change in pulmonary vascular resistance compared to placebo for any of the doses studied. The IMPAHCT trial was initiated in December … [Read more...] about Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Ethris announces $5 million in funding from the Gates Foundation and additional €3 million from Cipla to support continued development of ETH47 inhaled mRNA therapy
Ethris announced that the Gates Foundation is providing $5 million, and Cipla is investing an additional €3 million, that will be used to prepare for Phase 2 development of Ethris's ETH47 inhaled mRNA therapy. According to the company, the Gates Foundation funding "includes an equity investment component expected to close at the company’s next financing round." The … [Read more...] about Ethris announces $5 million in funding from the Gates Foundation and additional €3 million from Cipla to support continued development of ETH47 inhaled mRNA therapy
Enterprise Therapeutics names Renu Gupta as Chief Medical Officer
UK-based Enterprise Therapeutics, which is developing inhaled ENaC blockers for the treatment of cystic fibrosis and other respiratory conditions, has named former Insmed Executive VP of Development and Chief Medical Officer Renu Gupta as the company's new CMO. Enterprise also announced the appointment of Janet Hammond, currently Chief Development Officer at Atea … [Read more...] about Enterprise Therapeutics names Renu Gupta as Chief Medical Officer
BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced that it has awarded approximately $40 million to CyanVac and approximately $34 million to CastleVax to support Phase 2b clinical trials of the companies' intranasal COVID-19 vaccine candidates. Each of the Phase 2b trials will … [Read more...] about BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
Firebrick launches Nasodine nasal spray in Singapore
Firebrick Pharma, which recently launched its Nasodine povidone-iodine nasal spray in the US as a "nasal hygiene" product, has now announced the launch of Nasodine in Singapore as a germicidal product for protection against infection. As in the US, the nasal spray will now be available to consumers in Singapore via a web site, though Firebrick says that it may be able … [Read more...] about Firebrick launches Nasodine nasal spray in Singapore
Bespak announces that it will soon allocate capacity for new LGWP MDI filling line
CDMO Bespak says that it has already received new MDI filling equipment for one new LGWP propellant MDI manufacturing line at its Holmes Chapel, UK facility and that it has ordered equipment for another LGWP line at that plant. Both lines will be able to handle both HFO-1234ze and HFA-152a. According to Bespak, 100% of capacity for the first of the new lines has … [Read more...] about Bespak announces that it will soon allocate capacity for new LGWP MDI filling line