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Biologics

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 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.

Pfizer and Merck KGaA Announce Strategic Alliance

November 17, 2014

Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.

First Biosimilar Application Kicks Off Legal Battle

October 31, 2014

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

SAFC Introduces New Protein Quality Supplement for Optimized Biologics Production

October 30, 2014

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

EMA Works to Speed Up Ebola Treatment

October 20, 2014

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Biopharma Manufacturers Respond to Ebola Crisis

October 2, 2014

Pharmaceutical Technology

Demand for new therapies and vaccines spotlights production challenges.

FDA and NIH Win Award for IP Licensing of Meningitis Vaccine

September 26, 2014

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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