FDA Works to Secure Drug Supply Chain
New policies aim to strengthen inspection and oversight processes.

EU Raises API Standards: A Curse in Disguise?
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

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MIT Receives $10.4 Million BioManufacturing Grant
The Biomanufacturing Research Program at Massachusetts Institute of Technology has received $10.4 Million from the Defense Advanced Research Projects Agency to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics.

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Judge Approves Consent Decree Against Shamrock Medical Solutions Group
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

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CDC Report Describes Antibiotic Resistance Threat
CDC says antibiotic resistance is a quickly growing and dangerous problem.

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Xofigo Injection Recommended for Approval in EU
The EMA Committee for CHMP recommends the approval of Xofigo in Europe.

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EMA's CHMP Recommends Approvals for 11 Medicines
CHMP recommended 11 new medicines for approval, the most approval recommendations at a CHMP meeting thus far in 2013.

CMDh Recommends Suspends Authorization for Numeta G13%E
The CMDh agrees to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia.

AstraZeneca, Bristol-Myers Squibb Recall Certain Lots of Bydureon
AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.