FDA must use caution with biosimilars

April 14, 2011

William P. Bro, Kidney Cancer Association At the Kidney Cancer foundation we’re constantly seeking new ways to ensure those with cancer have access to the best medical data and medicines possible. For the past 20 years, we have served as a source of support and information for individuals and their loved ones affected by kidney […]

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Drugmakers could take hit under Obama budget

February 16, 2011

Obtaining approval of new drugs can take as much money as $1 billion by the time research, manufacturing, safety and clinical trials have concluded. The pharmaceutical company patents the drug as soon as it is made, usually very early in the process of drug development. The patent protects that drug from being copied by anyone […]

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Obama budget targets brand name medicines

February 14, 2011

Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year’s healthcare law. Read More

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Biologics Exclusivity Cut Called for in President’s Budget: All Bark, No Bite

February 14, 2011

The Obama Administration’s fiscal 2012 budget document includes a call to reduce innovator biologics exclusivity from the 12 years just enacted as part of the health care reform law to 7 years, a number more in line with the position supported by advocates on the generic/drug/purchaser/consumer side of the debate. Read More

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Next generation biologic drugs provide hope for HIV/AIDS patients

January 26, 2011

James Sykes, Director of Global Policy, The AIDS Institute The Hill Our nation’s political capital, Washington D.C. also has the notorious distinction of being the HIV and AIDS capital of the United States, with at least 3 percent of its residents infected. This rate is higher than most countries in West Africa and exceeds the […]

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European Union provides a good example of effective biosimilars pathway

December 14, 2010

Biologic drugs can treat a variety of illnesses—including cancer and certain types of arthritis—imore effectively than traditional, chemical based products.

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FDA must establish safe approval pathway for biosimilar drugs

December 14, 2010

Biologic drugs are often referred to as ”miracle drugs“ for good reason…

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Proceed with caution on creating ‘biosimilar’ drugs

November 15, 2010

Americans elected a new Congress on Nov. 2, but the voting booth wasn’t the only place where critical issues were at stake that day.

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Biologics: Are Unsafe Drugs an ‘Acceptable Risk?’ FDA Should Say ‘No!’

November 7, 2010

For cancer patients, what is the “acceptable risk” that a drug will pose safety risks or won’t work properly?

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Clinical Trials Key to Keeping New Drugs Safe

October 29, 2010

Patient safety is a core component of our medical system.

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