Patient Safety Depends on Prevention

June 29, 2011

By Andrew R. Spiegel CEO, Colon Cancer Alliance MedCity News Prevention is a key message of the Colon Cancer Alliance. Over 80% of all cases of colorectal cancer can be prevented with recommended screenings. Despite its high incidence, colorectal cancer is one of the most detectable and, if found early enough, most treatable forms of […]

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Patient Safety with Biosimilars: Not the Same, Only Similar

June 24, 2011

By Bruce S. Rubin, MD Assistant Professor of Clinical Neurology, University of Miami Miller School of Medicine Opposing Views Scientific advancements in medicine are important achievements that improve quality of life for many people.  One recent example is in the field of biotech medicines.  But in the rush to make generic versions of these drugs, […]

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European Medicines Agency and US Food and Drug Administration set up biosimilar ‘cluster’ and publish first report on interactions

June 23, 2011

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on biosimilar medicines.  Clusters are topic areas of mutual interest for the two agencies, which they have identified as benefiting from the regular exchange of information and collaborative meetings. Biosimilar medicines is the latest addition […]

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Why Biotechs Need To Worry About Generics, Too.

June 14, 2011

By Brian Gormley Wall Street Journal U.S. pharmaceutical companies have long lived with generic rivals, and soon biotechnology concerns will face similar competition. Through the health-care reform law passed last year, Congress created a regulatory path for companies to introduce “biosimilars,” or nearly exact copies of biological drugs that have come off patent. Read More

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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 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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