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FDA accepts Sandoz's biosimilar version of Neupogen for review

BIO SmartBrief | Jul 25, 2014

The FDA has agreed to review Sandoz's biologics license application for Zarzio, its biosimilar version of Amgen's Neupogen, or filgrastim, which is indicated for reducing the rate of infection that leads to neutropenia in cancer patients receiving chemotherapy. The application makes the Novartis subsidiary the first company to submit a biologic drug for FDA review under the biosimilars pathway. Sandoz already markets Zarzio in over 40 countries outside the U.S. Chain Drug Review (07/24) Reuters (07/24)


AstraZeneca, Advaxis agree to combine cancer drugs in clinical trial

BIO SmartBrief | Jul 23, 2014

U.S. needs new mechanisms to encourage drug development

BIO SmartBrief | Jul 23, 2014

USDA report confirms U.S. farmers prefer biotech crops

BIO SmartBrief | Jul 24, 2014

Pancreatic cancer drug combo wins breakthrough status from FDA

BIO SmartBrief | Jul 22, 2014

Report: Ethanol production to increase through 2023

BIO SmartBrief | Jul 22, 2014

U.K. academia gains access to pharma's abandoned compounds

BIO SmartBrief | Jul 23, 2014

Sandoz's PharmaDerm gains marketing rights to Anacor's antifungal drug

BIO SmartBrief | Jul 22, 2014

Ono signs cancer-immunotherapy pact with Bristol

BIO SmartBrief | Jul 25, 2014

Plant-based biopharma facility planned for Brazil

BIO SmartBrief | Jul 25, 2014


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Announcing the BIO Latin America Conference!

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