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SAFC Installs Continuous-Flow Reactor

May 21, 2014

SAFC offers commercial and pilot-scale continuous-flow capacity.

FDA Approves Entyvio for Ulcerative Colitis and Crohn's Disease

May 21, 2014

DA approves Entyvio, an injection to treat adult patients with moderate to severe ulcerative colitis and Crohn's disease.

AstraZeneca Rejects Pfizer's Final Offer

May 19, 2014

AstraZeneca rejects Pfizer's final offer of $118 billion for a proposed merger of the two companies.

Novasep Commissions Plant Extension for Highly Potent APIs

May 15, 2014

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

EMA Opens Registration for European Network of Paediatric Research Workshop

May 15, 2014

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

FDA and EMA Join Forces on Treatment of Gaucher Disease in Children

May 15, 2014

FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.

FDA Releases Q&A on ANDAs and Stability Testing

May 14, 2014

FDA clarifies stability data recommendations for abbreviated new drug applications.

FDA Releases Draft Guidance on Biosimilarity

May 14, 2014

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA Revises Guidance on HABP and VABP Drugs

May 8, 2014

FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.

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