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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.

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

EMA Revises Guidance on Advanced Therapies

July 1, 2014

European Medicines Agency clarifies advanced-therapy medicinal products classification.

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.

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.

Medicenna Therapeutics Selects Kalon Biotherapeutics To Manufacture New Cancer Drug

June 26, 2014

Medicenna Therapeutics selects Kalon Biotherapeutics to manufacture a new brain cancer drug for children and adults.

FDA Issues Warning Letter to GSK Biologicals

June 26, 2014

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

More than 430 New Medicines in Development for Chronic Diseases

June 26, 2014

PhRMA announced 430 new medicines in development to treat chronic diseases affecting older Americans.

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