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


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


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


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 cancer and related illnesses. Read more


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 cancer and related illnesses. Read more


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


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 else for 20 years, but it can take well more than half that time to get the drug on the market. Read More


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 else for 20 years, but it can take well more than half that time to get the drug on the market. Read More


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 develop new drugs and generate profits. Read More


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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