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Baxter Issues Recall Due to Particulate Matter

July 11, 2014

Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.

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.

Biotech Industry Forms International Council

July 10, 2014

New International Council on Biotechnology Associations advocates biotechnology growth.

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.

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