Industry News

Sep 24, 2018
By BioPharm International Editors
FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.
Sep 24, 2018
By BioPharm International Editors
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.
Sep 21, 2018
By BioPharm International Editors
Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.
Sep 19, 2018
By BioPharm International Editors
Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.
Sep 17, 2018
By BioPharm International Editors
In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.
Sep 17, 2018
By BioPharm International Editors
FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.
Sep 14, 2018
By BioPharm International Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 14, 2018
By BioPharm International Editors
Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease.
Sep 14, 2018
By BioPharm International Editors
Researchers at Vanderbilt University Medical Center have isolated the first human monoclonal antibodies (mAbs) that can neutralize norovirus, a virus that causes acute gastrointestinal (GI) illness.
Sep 12, 2018
BioPharm International
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
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