News Articles
The Ins and Outs of EAPs
For a patient who is running out of hope, waiting for a drug to be approved can be interminable. Even on the fast track, a review can take six months or longer. Some patients with life-threatening diseases cannot afford to wait. In response, many countries have developed expanded access programs (EAPs) that give patients with no other viable alternative access to medically important drugs before they are commercialized.
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Pfizer to acquire Pharmacia
After four years of partnership through the co-promotion of the COX-2 inhibitor Celebrex® (celecoxib), New York-based Pfizer Inc. has acquired Peapack, NJ-based Pharmacia Corp. in a stock-for-stock transaction valued at $60 billion. "This is an extraordinary opportunity to combine two of the fastest-growing and most innovative pharmaceutical companies and to position Pfizer for sustained, long-term leadership of the global pharmaceutical industry," said Hank Mc-Kinnell, chairman and chief executive officer of Pfizer. "By combining with Pharmacia, we are ensuring that our core capabilities in the discovery, development and commercialization of new medicines are strong around the world."
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FDA Considers Stronger Warnings On OTCs
An FDA advisory committee is recommending that over-the-counter painkillers bear stiffer warnings in light of continued episodes of liver and other internal organ damage when consumers take the products in combination with other medications. Acetaminophen is considered safe when taken as directed, but used in large doses over an extended period of time-which FDA's Non-prescription Drugs Advisory Committee believes can happen when consumers take it in combination with other prescription drugs that also contain acetaminophen-the product has potentially deadly results
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Embracing HIPAA's Ethics
Michael J. Rozen, MD
Pharmaceutical Executive, Aug 2, 2002
Call for Aid to Afghanistan
Kevin Gopal
Pharmaceutical Executive, Apr 1, 2002
Document Leak: NICE Says No to MS
London-Schering and Biogen have both expressed anger over the leak of a National Institute of Clinical Excellence (NICE) document suggesting that doctors stop prescribing beta-interferon to new multiple sclerosis (MS) patients.NICE was forced to release the contents of the document, known as a provisional appraisal determination (PAD), on its website after the information was leaked to the press. It concluded that, on the basis of clinical or cost-effectiveness, neither glatiramer acetate nor beta-interferon should be recommended for use in England and Wales.
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A Better Way to Manage the Pipeline
A major unresolved issue for the pharmaceutical industry in the 21st century is that few, if any, optimization techniques have found their way into the research portfolio arena. That is surprising, for several reasons: The industry has been very open to using sophisticated mathematical optimization techniques in the sales and marketing arenas. Research project management increasingly includes MBAs who are familiar with these techniques.
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Over one-third of docs say they have experienced medical errors
Forty-two percent of the American public and more than one-third of U.S. doctors say they or their family members have experienced medical errors in the course of receiving medical care, according to a survey by the Harvard School of Public Health and the Washington-based Kaiser Family Foundation. The nationwide survey examined the views of 831 physicians from April to July 2002 and 1,207 adults from April to June 2002. However, implementing the actions recommended by experts on medical errors may not be easy. Despite widespread personal experience, neither the public nor physicians named medical errors as a top problem facing healthcare and medicine today.
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Membership Has Its Privileges
All is quiet at the Drug Information Association's new headquarters, a short ride from the hubbub of Philadelphia. But inside, the association buzzes with change as it harnesses the expertise and energy of its members to improve healthcare around the world. Now approaching its 40th year, DIA is expanding both its educational programs and its global reach. An association member since 1967, Executive Director Bob Assenzo confesses that his history is wrapped up with DIA's. He shares both accounts in an easygoing style, combining industry expertise gained from his former jobs in the regulatory departments of Novo Nordisk and Upjohn with the idealism of a director of a nonprofit organization.
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More Statins = Fewer Heart Attacks
Sarah Houlton
Pharmaceutical Executive, Sep 1, 2002
