How To Disseminate Complete Clinical Trial Data
The growing controversy over releasing clinical trial data – and the extent to which underlying patient-level data should be disclosed – has yet to be resolved. In the interim, debates have raged about patient safety, the utility of meta-analyses for deciphering safety issues and obligations of drug and device makers to physicians and patients. And […]
Read More »Category : News
FDA approval of ancient remedy sends price soaring
Scott McGrath, 24, suffers from a painfully inflamed lining of the heart. Four months ago, the price of his medication suddenly went through the ceiling. Sixty tablets of Colchicine used to cost him $34.83, and cost his insurance company nothing. CBS News medical correspondent Dr. Jon LaPook reports the medication is now called Colcrys, and […]
Read More »Category : News
US FDA Warns Of Rare Heart/Lung Problem With Bristol-Myers Drug
The U.S. Food and Drug Administration said a Bristol-Myers Squibb Co. (BMY) leukemia drug could increase the risk of a rare high-blood pressure problem in the lungs called pulmonary arterial hypertension. In a drug-safety communication posted on the FDA’s website Tuesday, the agency said the label for the drug, Sprycel, has been updated to warn […]
Read More »Category : News
FDA adds new warnings to Bristol cancer drug
Federal health officials are warning doctors about a rare but dangerous side effect of a Bristol-Myers Squibb leukemia drug that can cause abnormally high blood pressure in the arteries in patients’ lungs. The Food and Drug Administration said Tuesday the company’s drug Sprycel will carry a new warning about increased risk of pulmonary arterial hypertension, […]
Read More »Category : News
EPA proposes fine for API plant over waste allegations
The US EPA plans to fine API manufacturer Rhode Technologies for alleged hazardous waste failings at its plant.
Read More »Category : News
Europe Revises ‘Advertising In Disguise’ Proposal
Three years after issued a widely criticized proposal that would have allowed drugmakers to publish product information in consumer newspapers and magazines, the European Commission has, as promised, issued an updated version. And policy makers vow this will strengthen regulatory controls over authorized medicines and how pertinent information is communicated to the public. The original […]
Read More »Category : News
A Petition To Scuttle Gilead Deal With Patent Pool
Three months ago, Gilead Sciences agreed to license four AIDS meds to the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and lower prices in poor countries. The deal marked the first time that a drugmaker took such a step and followed more than […]
Read More »Category : News
Pfizer Settles Norplant Lawsuits For $29.5 Million
After 17 years of litigation, Pfizer has reached a preliminary agreement to settle a Norplant contraceptive class action lawsuit for $29.5 million, according to Mealey’s Drugs & Devices Report. The lawsuit, which was scheduled to go to trial in Louisiana, was brought by 3,500 to 4,000 women. The move comes a decade after Wyeth, which […]
Read More »Category : News
Merck Gets A Vioxx Loss In Australia Overturned
In a potentially significant victory, an Australian court has overturned a ruling last year that found merck liable for a heart attack that a Melbourne man suffered after taking the Vioxx painkiller, which was withdrawn in 2004 over links to heart attacks and strokes. The move by the drugmaker turned Vioxx into a poster child […]
Read More »Category : News
Teva, Baxter, Mckesson to Pay $162 Million Punitive Damages Over Propofol
A jury said Teva Pharmaceutical Industries Ltd. (TEVA) unit and two other drugmakers must pay $162.5 million in punitive damages for selling the anesthetic Propofol in a way that led three colonoscopy patients to develop Hepatitis C. Jurors in state court Las Vegas ordered Teva Parenteral Medicines Inc., Baxter Healthcare Corp. and McKesson Corp. to […]
Read More »Category : News
