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
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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
Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA
According to Agomab Therapeutics, the company's AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in December 2023. Agomab Chief Medical Officer Philippe Wiesel commented, “Receiving orphan drug designation from the FDA provides … [Read more...] about Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA
Kindeva announces additional expansion of its Loughborough UK facility
CDMO Kindeva Drug Delivery has announced an expansion at its facility in Loughborough, UK to add dedicated laboratory space for analytical laboratory services. According to the company, the new Loughborough facility will double its lab space in the UK. In January 2024, Kindeva announced that it was launching an analytical laboratory services business and was opening a … [Read more...] about Kindeva announces additional expansion of its Loughborough UK facility
Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Earlier this year, the company said that … [Read more...] about Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
Cardiff Scintigraphics / i2c name Andrew Brown as CEO
Cardiff Scintigraphics, the parent company of inhalation CRO i2c Pharma Services, has named former OBG Pharmaceuticals Chief Scientific Officer Andrew Brown as CEO, succeeding Glyn Taylor, who will continue part time as Chief Scientific Officer. Brown was most recently Chief Scientific Officer and Operations Director of OBG subsidiary Noveayr Therapeutics, which … [Read more...] about Cardiff Scintigraphics / i2c name Andrew Brown as CEO