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Innovation That Matters

A New Hope for Glioblastoma

Celldex’s investigational immunotherapy rindopepimut received Breakthrough Therapy Designation from the FDA Celldex Therapeutics, headquartered in Hampton, New Jersey announced on February 23 that the US Food and Drug Administration (FDA) has granted its rindopepimut Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive...

Improving Gene Editing with Drugs: An Interview with Dr. Sheng Ding

CRISPR/Cas technology adapted from the bacterial immune system has received tremendous attention from medical research and technology community.  With the advent of genomic sequencing and subsequent disease predisposition gene discovery, this technology offers enormous opportunities to correct genetic defects for patients suffering from rare...

Gene Therapy Offers Potentially New Treatment for beta-Thalassemia Patients

Bluebird Bio Inc., a leading gene therapy biotech company based in Cambridge, Massachusetts, announced on February 2 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to one of its investigational drugs, LentiGlobin® BB305 for the treatment of transfusion-dependent patients...

A New Weapon to Fight Breast Cancer

Congratulations to Pfizer for receiving accelerated approval for its investigational new drug, IBRANCE to treat advanced breast cancer from the U.S. FDA on February 3.  IBRANCE is an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) involved in promoting the growth of cancer cells. IBRANCE is...

BCX4161, a Promising New Orally Administered Drug for the Rare and Genetic Disorder Hereditary Angioedema, Received Fast Track Status from the FDA

BioCryst Pharmaceuticals, Inc., a small pharmaceutical company headquartered in Durham, North Carolina announced on January 26 that one of the drugs in the company’s pipeline, BCX4161 has been granted fast track status by the FDA. BCX4161 is a novel and selective inhibitor of plasma kallikrein...

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WuXi AppTec Acquires ResearchPoint Global to Better Enable Clinical Development Worldwide

We are pleased to announce that WuXi has acquired ResearchPoint Global (RPG), a U..S-based contract research organization (CRO) with expertise spanning across all major...