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Mylan to Acquire Abbott's Non-US Businesses in $5.3 Billion Stock Deal

July 14, 2014

Mylan set to acquire Abbott's non-US developed markets specialty and branded generics business in an all-stock transaction.

Shire and AbbVie Discuss Possible Deal

July 14, 2014

New AbbVie proposal results in discussion with Shire about possible $53 billion deal.

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.

Hospira Issues Recall Due to Mold Contamination

July 11, 2014

Puncture in container and overwrap cause leak in intravenous solution, leading to recall by Hospira.

FDA Publishes Guidance on ANDA Submissions

July 10, 2014

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

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.

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.

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