Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Harmonizing Marketing Approval of Generic Drugs in Europe
Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Bolstering Graduate Education and Research Programs
AAPS supports graduate-level programs impacted by cutbacks in funding and resources.

FDA Reorganization to Promote Drug Quality
After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.

Harnessing the Power of Modified T Cells to Treat Cancer
Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

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FDA Approves OFEV for the Treatment of Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim's OFEV was approved by FDA as the first treatment for idiopathic pulmonary fibrosis, a fatal lung disease.

Genentech Announces FDA Approval of Idiopathic Pulmonary Fibrosis Treatment
Genentech announced FDA-approved Esbriet for the treatment of Idiopathic Pulmonary Fibrosis.

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Sanofi Pasteur and Immune Design Collaborate to Develop Herpes Simplex Virus Therapy
Sanofi Pasteur and Immune Design agree to jointly develop therapies through Phase II clinical trials.

FDA Approves CMO Facilities for Halozyme Product
FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.

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BioReliance Adds Advanced In-Vitro ADME and Toxicology Services
BioReliance has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services its service offering. The company's range of predictive assays use a novel suite of genetically modified cell lines created with CompoZr zinc finger nuclease (ZFN), a Sigma-Aldrich proprietary technology.

Wuxi's Biologics Facility Receives Honorable Mention at ISPE Facility of the Year Awards 2014
The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE).

Pfizer Ireland Plant Receives ISPE Award
Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.