OINDPnews


Aptar Pharma banner

News

Verona announces appointments in preparation for potential commercialization of ensifentrine

Verona Pharma, which recently announced that a Phase 3 trial of its nebulized ensifentrine for the treatment of COPD met its primary endpoint, has announced the appointments of Matthew Casbon as VP of Sales, Marketing, and Training and Matthew Rysavy as VP of Market Access and Trade in preparation for potential commercialization. Casbon was most recently Chief … [Read more...] about Verona announces appointments in preparation for potential commercialization of ensifentrine

Savara’s molgramostim for aPAP gets PIM designation from the MHRA

According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company's molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation indicates that the product could be eligible for the UK's early access to … [Read more...] about Savara’s molgramostim for aPAP gets PIM designation from the MHRA

Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing

A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals "to stop manufacturing and distributing drugs alleged to be adulterated." The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products. The company has signed a consent decree agreeing to cease production, to destroy already manufactured drugs, … [Read more...] about Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing

Nob Hill names Noel Greenberger as CEO, gets $1.7 million grant for development of a nebulized dry powder antifungal

Dry powder nebulizer developer Nob Hill Therapeutics announced the appointment of Noel Greenberger as its new CEO, replacing interim CEO Yun Li as of September 1, and said that it has received a Department of Health and Human Services (HHS) Small Business Innovation Research (SBIR) Phase 2 grant of up to $1.73 million for development of a dry powder antifungal … [Read more...] about Nob Hill names Noel Greenberger as CEO, gets $1.7 million grant for development of a nebulized dry powder antifungal

SaNOtize raises $24 million for development of NONS nitric oxide nasal spray

SaNOtize announced that it has closed a $24 million Series B funding round led by Horizons Ventures and OurCrowd with proceeds to go towards continued development of the company’s NONS nitric oxide nasal spray. The company initiated a Phase 3 trial of NONS for the treatment of COVID-19 in June 2021 and announced positive results from that study in July 2022. In August … [Read more...] about SaNOtize raises $24 million for development of NONS nitric oxide nasal spray

FDA approves Lupin’s formoterol fumarate inhalation solution

According to Lupin, the FDA has approved the company's ANDA for a generic version of Mylan's Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of the final patent covering Perforomist, and the agency approved Alembic Pharmaceuticals' ANDA for its Perforomist equivalent in November 2021. … [Read more...] about FDA approves Lupin’s formoterol fumarate inhalation solution

Lee’s acquires global rights to Windtree’s Aerosurf aerosolized KL4 surfactant

Windtree Therapeutics said that it has signed a deal with Lee’s Pharmaceutical and its subsidiary Zhaoke Pharmaceutical giving Lee's global rights to develop and commercialize Windtree surfactants for any potential indications, including Aerosurf aerosolized KL4 surfactant for the treatment of premature infants with respiratory distress syndrome. According to … [Read more...] about Lee’s acquires global rights to Windtree’s Aerosurf aerosolized KL4 surfactant

Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China

According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company's IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to … [Read more...] about Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China

NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis

The US National Institutes of Health (NIH) has published a notice in the Federal Register regarding the availability of intellectual property related to the use of inhaled thrombin inhibitors for the treatment of lung fibrosis caused by SARS-CoV-2 infection. The notice says that the technology "is available for licensing to achieve expeditious commercialization of … [Read more...] about NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis