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EMA Recommends 39 Drugs in First Half of 2014

July 10, 2014

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

FDA Publishes Guidance on ANDA Submissions

July 10, 2014

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

Novartis Personalized Cell Therapy Receives FDA Breakthrough Therapy Designation

July 9, 2014

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA Outlines Guidance and Rules for Compounding Drug Products

July 1, 2014

FDA releases guidance documents and rules on requirements for compounding human drug products.

EMD Serono and Mersana to Develop Next-Generation Antibody-Drug Conjugates

July 1, 2014

The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.

EMA Revises Guidance on Advanced Therapies

July 1, 2014

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Merck Collaborates with Bionomics on Alzheimer's Treatments

July 1, 2014

Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders

FDA Issues Warning Letter to GSK Biologicals

June 26, 2014

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

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