The Disconnect Continues: Amgen Rethinks R&D
Taking a page from the big pharma playbook, Amgen is planning to reorganize its R&D operations. And sources says the biotech plans to cut a chunk of the budget and may place less emphasis on discovery. Such a move would mimic what many big drugmakers have been doing in recent years as they attempt to […]
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Birth Control Pills, Boring Lovers & Good Husbands
If hormones can sway what a woman thinks of a man and whether he is a good mate, what might oral contraceptives do? Well, a study of 2,519 women finds that those using birth control pills when they met their match were less sexually satisfied or attracted to their partners, but more content with other […]
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Senators Want To Ease FDA Panel Conflict Rules
Three years after the FDA enacted tougher conflict of interest rules for its advisory committees, a legislative effort is under way to roll back the policy. A trio of US Senators has introduced a bill that would reverse agency regulations that bar experts with financial ties to drug or device makers from serving on the […]
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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 […]
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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 […]
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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 […]
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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, […]
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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.
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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 […]
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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 […]
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