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Amgen Opens Single-Use Manufacturing Plant in Singapore

November 20, 2014

The $200-million project will expand Amgen's single-use/disposable manufacturing capabilities.

GPhA Issues Statement on Generic Drug Costs

November 20, 2014

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

Manufacturing Issues Crucial to Combating Ebola

November 20, 2014

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA Requests Comments on Generic Drug Submission Criteria

November 20, 2014

FDA opens public docket on proposed criteria for “first generic” ANDAs.

USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting

November 20, 2014

USP and ChP jointly host two-day meeting to strengthen cooperation.

FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper

November 19, 2014

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.

Roche's Avastin Gains Ovarian Cancer Indication

November 17, 2014

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

FDA Issues Draft Guidance on Rare Pediatric Diseases

November 17, 2014

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

FDA Approves Lemtrada for the Treatment of Multiple Sclerosis

November 17, 2014

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

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