When It Comes to Patient Safety, Caution Isn’t a Four-letter Word

May 20, 2011

By Jorgo Chatzimarkakis, PhD, member of European Parliament The Health Care Blog Around the world and now in the United States, there is a broadening discussion of how best to proceed down the path of approving and getting to market medicines called biosimilars. Biosimilars are non-identical copies of next generation medicines known as biologics. As […]

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FDA’s Rush in Generic Drug Testing Could Harm Patients

May 19, 2011

By Andre Williams, Association of Black Cardiologists Politic365.com President Barack Obama recently indicated his interest in improving the Food and Drug Administration’s (FDA) approval process for new medical devices, saying the agency could “keep patients safer while getting innovative and life-saving products to market faster.” Read More

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Initial Biotechnology Drug Copies May Get Brand-Name Fees

May 10, 2011

Drugmakers seeking U.S. approval for the first lower-cost copies of biologic medicines made from living cells should initially pay application fees similar to charges for brand-name medicines, regulators said. Read More

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Latest biotech medicine needs new safety rules

April 24, 2011

Dr. Marcy L. Zwelling-Aamot Sacramento Bee When it comes to biologics, is biosimilar good enough? There is a new development in pharmaceuticals. It is a class of drugs called biologics. They are not only new; they are each unique. Read More

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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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Workplace drug plans due for ‘radical change’: experts

April 14, 2011

Tom Blackwell, National Post A growing tide of high-priced specialty medicines for arthritis, cancer and other diseases is set to put unprecedented pressure on workplace drug plans, likely forcing strict limits on what they cover, higher employee premiums and even an end to some plans altogether, experts are warning. Read more

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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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Drug Firms Attack U.S. Patent Plans

February 16, 2011

A U.S. government proposal to bring cheaper generic drugs to the market more quickly and help curb health-care costs has triggered criticism from the European pharmaceutical sector. Many drug makers fear that cutting the patent protection for biologic drugs to seven years from 12 years will upend their business models and curtail their ability to […]

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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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