Top Stories
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
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A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.
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Industry News
A new report states that more research and clinical development must be done in the treatment of pain and addiction.
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Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.
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Biopharma News
Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.
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The companies will work together on developing regenerative medicine therapies for heart failure.
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Regulatory News
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
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The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
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Supplier News
Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.
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The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.
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MANUFACTURING
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
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GMPs
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
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QUALITY SYSTEMS
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
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Events
February 26–March 1, 2018
March 12–14, 2018
March 20–21, 2018
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eBook
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
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