Manufacturers Weigh Strategies to Prevent Drug Shortages
Drug shortages are declining, but they're still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

Sagent Pharmaceuticals Recalls Atracurium Besylate Injection
The company voluntarily recalls product due to FDA observations of potential sterility problems.

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FDA Issues Warning Letter to India Facility
The agency cites Apotex's Bangalore facility with quality system failures.

Kite Pharma Expands Manufacturing for T-Cell Therapies
Leased facilities in California will expand Kite Pharma's capacity for clinical T-cell therapies.

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Revlimid Gains FDA Approval for NDMM Patients
Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.

Sanofi Appoints Bayer's Brandicourt as New CEO
Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Is It Time to Ditch QbD for Development by Design? Questions From a QbD Cheerleader
QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges?

EMA Establishes Drug Identification Task Force
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

Siegfried Announces Resolution of Hameln Pharma Regulatory Issues
The company announces that FDA has closed out a 2012 warning letter.

NIST Partners with MedImmune on Protein Characterization Venture
MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Johnson & Johnson's Remicade Patent Invalidated
The Patent and Trademark Office sends notice rejection of the company's Remicade patent.

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