Pharmaceuticals

Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group

Jan. 14, 2008 -- Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug today: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk.    » read more »

01/09/2008 -- A group of Internet pill peddlers may soon be forced to change their ways after Oklahoma Attorney General Drew Edmondson today filed a petition for a permanent injunction against the company in Oklahoma County District Court.

Pure Energy Labs, Inc. and three of the company’s executives, Darrin Clanton, Brian Forrester and Chris Wilson, were named in the state’s complaint after the attorney general’s office received more than 115 complaints from consumers regarding the company’s business practices.    » read more »

State, Feds Partner with Boy Scouts to Find Residents Qualified for Drug Program

December 20, 2007 -- Montpelier, Vt. – Vermont Governor Jim Douglas today joined officials from Medicare and the Green Mountain Council, Boy Scouts of America to encourage eligible senior citizens to enroll in the federal Medicare prescription drug program.    » read more »

12 November 2007 -- Experts on lung disease meeting in South Africa are warning the world could face a tuberculosis crisis if drug resistant strains of TB are not contained and if TB testing does not become a regular part of HIV treatment.

Three thousand experts from 100 countries ended a five-day conference in Cape Town warning that urgent measures are needed to address the spread of drug-resistant tuberculosis and its growing presence among victims of HIV/AIDS.    » read more »

November 9, 2007 -- "This agreement in principal - the result of an unprecedented investigative partnership between Connecticut and the U.S. Attorney's Office in Philadelphia - will return millions of dollars to the Medicaid program. If it becomes final, the Cephalon settlement by no means ends Connecticut's intensive ongoing investigation into the company's off-label marketing.    » read more »

Jerusalem, Israel, October 8, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg.    » read more »

Statement of Dr. Sidney Wolfe, Director of the Health Research Group at Public Citizen

Oct. 4, 2007 -- The idea of behind-the-counter-drugs is not new. The Food and Drug Administration (FDA) has previously considered creating a third class of drugs - an intermediate step between prescription medications and over-the-counter drugs - but has not supported the idea, citing the need for more research. That need still exists today.    » read more »

October 05, 2007 -- Kentucky Attorney General Greg Stumbo today announced the filing of a lawsuit against Purdue Pharma, the manufacturer of OxyContin, a highly abused narcotic.

The lawsuit alleges that Purdue Pharma misrepresented the risks of using OxyContin and seeks to recover damages suffered state and county governments related to widespread addiction caused by the drug.

(Click here for a copy of the Complaint: http://tinyurl.com/2qyfky)    » read more »

October 4, 2007 -- Genzyme Corp. (NASDAQ: GENZ) announced today that it has received approval to market Elaprase® (idursulfase) in Japan for the treatment of Hunter syndrome. Elaprase is an enzyme replacement therapy developed by Shire Human Genetic Therapies Inc., and Genzyme is commercializing the product in Japan and other Asia Pacific countries under an agreement with Shire. Genzyme intends to launch Elaprase this quarter, following reimbursement approval.    » read more »

September 26, 2007 -- Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).    » read more »

Includes protections for scientists, promotes openness

September 19, 2007 -- The U.S. House of Representatives passed the Food and Drug Administration Amendments Act that takes steps to protect science and federal scientists at the agency, but fails to address serious conflict of interest issues, according to the Union of Concerned Scientists (UCS). The Senate is expected to pass this legislation.    » read more »

Statement By Francesca Grifo, Union of Concerned Scientists

WASHINGTON (September 21, 2007) - Congress has given final approval to the Food and Drug Administration Revitalization Act, which will hold the FDA more accountable for the drugs it approves. The law requires the agency to publicize the basis for its decision, as well as whether there was any dissent and from whom. This will help ensure that the FDA relies on scientific research in making decisions about new drugs.    » read more »

September 18, 2007 -- Carson City, NV - Nevada Attorney General Catherine Cortez Masto announced today that her office has reached a settlement with The Purdue Frederick Company, Inc., a New York corporation, and Purdue Pharma, L.P., a Delaware limited partnership, which are associated entities engaged in the manufacture, marketing, and distribution of OxyContin, an extended-release form of oxycodone.

Under the terms of the settlement, the State of Nevada recovered $1,047,787.19 to recoup damages to the Nevada Medicaid program as well as damages for investigative costs and penalties.    » read more »

A Second Exploratory Study Comparing Exubera and Lantus Assessed Daily Blood Sugar Levels in Patients with Type 2 Diabetes

Selzentry™ (Maraviroc) Now Available Throughout the U.S. for Use in Combination Therapy for Certain Treatment-Experienced HIV Patients