RDD Online has announced that nominations are open for the 2018 Charles G. Thiel Award, and the committee will accept nominations through November 30, 2017. The award will be presented at RDD 2018, which will be held April 22-26, 2018 in Tuscon, Arizona. According to the award announcement, "Award winners may have performed fundamental research leading to the … [Read more...] about RDD accepting nominations for the 2018 Charles G. Thiel Award
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Acorda gets refusal to file letter for Inbrija inhaled L-dopa NDA
Acorda Therapeutics has received a refusal to file letter from the FDA in response to its NDA for Inbrija (CVT-301) inhaled levodopa for the treatment of OFF periods in Parkinson’s disease patients, the company said. Acorda submitted the 505(b)(2) NDA in June 2017. According to the company, the FDA letter said that the NDA lacked sufficient information for review, … [Read more...] about Acorda gets refusal to file letter for Inbrija inhaled L-dopa NDA
CF PharmTech raises $65 million for inhaled drug development
Chinese inhaled drug developer and CDMO CF PharmTech has raised $65M in a Series D financing round led by Future Industry Investment Fund (managed by SDIC Fund Management), the company said. The money is to be used for development of the company's own OINDPs and for expansion of its CDMO services. SDIC Fund Management Managing Direct Hai Lu said, "Drug delivery via … [Read more...] about CF PharmTech raises $65 million for inhaled drug development
Propeller Health and GSK extend deal for use of Propeller sensor with Ellipta DPIs
Propeller Health and GSK have announced that their December 2015 agreement for development of a sensor for use with the Ellipta dry powder inhaler has been expanded, and R&D activities related to the use of the Propeller platform with GSK products for asthma and COPD will continue. The Propeller clip-on sensor for the Ellipta DPI received CE mark approval and 510(k) … [Read more...] about Propeller Health and GSK extend deal for use of Propeller sensor with Ellipta DPIs
US company selling “lollipop nebulizer”
A US company is selling a device marketed under the name Loli-O that promises delivery of nebulized medication to a child in the form of a cloud that emerges around a lollipop while the child sucks on the candy. The company makes no claims of having conducted clinical trials or of having applied for FDA approval. An "instructional video" claims to "put the treat … [Read more...] about US company selling “lollipop nebulizer”
Altimmune submits IND for NasoVax
Altimmune has submitted an investigational new drug application to FDA for its NasoVAX intranasal flu vaccine and is planning a Phase 2 study of the product, the company said. The safety and immunogenicity study is anticipated to enroll 60 volunteers, with data available in early 2018, and is expected to be followed by a larger immunogenicity study for a quadrivalent … [Read more...] about Altimmune submits IND for NasoVax
Lee’s Pharmaceutical to acquire controlling interest in Windtree Therapeutics
Hong Kong-based Lee's Pharmaceutical will advance Windtree Therapeutics up to $3.9 million through the end of October 2017 during negotiations for Lee's to acquire a controlling interest in Windtree. The first installment of the loan has already been received by Windtree, the company said. In June 2017, Windtree announced that Lee's had acquired the rights to … [Read more...] about Lee’s Pharmaceutical to acquire controlling interest in Windtree Therapeutics
Adherium announces sale of 100,000th Smartinhaler
Adherium has now manufactured and sold 100,000 of its Smartinhaler inhaler monitoring devices, the company has announced. According to Adherium, the Smartinhaler has been sold in more than 40 countries to date. The Smartinhaler platform received FDA 510(k) clearance in 2014 and is currently being used in the myAirCoach project in Europe. In 2015, Adherium … [Read more...] about Adherium announces sale of 100,000th Smartinhaler
Intranasal Ampligen found to be well tolerated in safety study
Hemispherx Biopharma has announced that a safety study of Ampligen plus FluMist in 25 healthy volunteers showed that intranasal Ampligen was generally well tolerated. Ampligen is a TLR-3 agonist, which the company is already developing for the treatment of chronic fatigue syndrome and for solid tumors. In previous studies of Ampligen for those indications, the … [Read more...] about Intranasal Ampligen found to be well tolerated in safety study
Aradigm gets SBIR grant for development of Linhaliq and Lipoquin for NTM
Aradigm Corporation has received a 2-year Small Business Initiative Research (SBIR) grant of about $972,000 from the National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) for development of Linhaliq and Lipoquin to treat pulmonary non-tuberculous mycobacteria (NTM) infections, the company said. The grant will support … [Read more...] about Aradigm gets SBIR grant for development of Linhaliq and Lipoquin for NTM