Auxilium Pharmaceuticals promotes James Tursi
Becomes chief medical officer having worked for US firm since 2009
Tursi entered the pharmaceutical industry in 2004 as a medical director for Procter and Gamble Pharmaceuticals. He worked on several products and therapeutic areas, including female sexual dysfunction, overactive bladder, and osteoporosis. His responsibilities included clinical development and medical affairs. He moved to GlaxoSmithKline Biologicals in 2006 and directed all Medical Affairs responsibilities for cancer vaccines in North America.
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Regulatory
WHO prequalifies Novartis' antimalarial Coartem Baby for treatment of newborns and young infants
The decision allows global procurement of artemether-lumefantrine (also known as Riamet Baby in some countries) for the first time, with Novartis adding that it will make the treatment available on a largely not-for-profit basis in malaria-endemic regions
Manufacturing
BD and Suttons Creek collaborate to streamline combination product development for pharma and biotech
The new strategic collaboration will help pharmaceutical and biotech companies reduce development risk and regulatory complexity across drug-device combination products, including biologics and GLP-1 therapies
Regulatory
FDA grants Orphan Drug Designation to pegrizeprument for prevention of heart transplant rejection
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Manufacturing
Cipla receives FDA approval for first AB-rated generic of Ventolin HFA in $1.5bn US albuterol market
Indian pharmaceutical company Cipla has secured final FDA approval for its Albuterol Sulfate Inhalation Aerosol, becoming the first AB-rated generic therapeutic equivalent of GlaxoSmithKline's Ventolin HFA
Manufacturing
Freudenberg Medical launches CleanAssure ISO Class 5 cleanroom service for sterile single-use biopharma assemblies
CleanAssure is an ISO Class 5 controlled cleanroom service delivering washed, dried and gamma-sterilised single-use assemblies to biopharmaceutical customers, addressing industry challenges around cleaning validation and contamination risk