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Production & Manufacturing

GSK announces positive real-world data for meningitis B vaccine in first year since UK immunisation programme

Preliminary data from the world’s first national meningitis B immunisation programme with Bexsero1, launched one year ago in the UK, shows the estimated effectiveness of the vaccine at 83 percent against any meningitis B strain and 94 percent. ...

Dr. Reddy’s Laboratories announces the launch of Bupropion HCl Extended-Release Tablets

Dr. Reddy’s Laboratories Ltd announced that it has launched Bupropion HCl extended-release tablets, USP (SR) in 100 mg, 150 mg and 200 mg, a therapeutic equivalent generic version of Wellbutrin® SR (bupropion HCl) Sustained-Release Tablets in the United States...

AstraZeneca enters commercialisation agreement with Aspen for  anaesthetics portfolio

AstraZeneca announced that it has completed the commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US. The agreement covers seven established medicines -...

TaiGen Biotechnology Out-Licenses Taigexyn® (Nemonoxacin) to Productos Científicos for the Latin American Market

TaiGen Biotechnology Company, Limited announced that they have signed an exclusive licensing agreement with Productos Científicos S.A. de C.V. ("PC"), a leading Mexican pharmaceutical company, to develop and commercialize Taigexyn® (nemonoxacin) in Latin America. Taigexyn® is...

Janssen Submits Application to U.S. FDA to Expand Indication for Daratumumab  

Janssen Biotech, Inc. announced a supplemental Biologics License Application (sBLA) for daratumumab (DARZALEX®) has been submitted to the U.S. FDA . The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an...

Agilent Chooses Colorado for New Pharma Manufacturing Facility

Agilent Technologies reports that it acquired 20 acres in Weld County in northern Colorado, on which it plans to build a pharmaceutical manufacturing facility. “The products manufactured at this site will be used by our customers...

Alexion issued new FDA Form 483 for Rhode Island plant

The FDA has again raised issues at an Alexion plant that three years ago was issued a warning letter. The facility is where Alexion manufactures what has been deemed the world’s most expensive drug, Soliris. Alexion...

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