Kennedy urges tough tests for generic biologic drugs
635540
WASHINGTON -- Federal regulators charged with approving generic versions of the world's most expensive drugs should follow the lead of their cautious European counterparts, according to Senator Edward M. Kennedy . In Europe, requirements for approval are tailored to the complexity of an experimental drug and can include clinical trials that cost millions for generic manufacturers to conduct.
497674
Democratic lawmakers in Congress introduced legislation yesterday that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it.
533898
HALIFAX (CP) - Nova Scotia's auditor general is calling for improvements to the province's costly prescription drug programs.
507463
WASHINGTON -- The US Senate yesterday hammered out a long-awaited bill that paves the way for generic versions of the world's most expensive drugs, while providing a 12-year financial cushion for local biotechnology leaders who worry that such lower-priced drugs would hurt sales of their name-brand products.
255832
Drug makers are worried that calls for greater disclosure of early-stage clinical trials might lead to the release of scientific information that could help competitors, an industry lobbyist said on Monday.
196378
A top Republican lawmaker on  Wednesday called on Merck & Co. Inc. to answer questions about  its withdrawn drug Vioxx at the first congressional hearing on  Nov. 18 to address the arthritis medicine's safety problems.
100886
Rising cost projections for the new  Medicare drug benefit alarmed U.S. lawmakers on Wednesday and  set off renewed calls to restrain spiraling drug prices and  allow pharmaceutical imports from Canada.
297541
Democratic lawmakers introduced legislation that would require makers of drugs and medical devices to register clinical trials of their products in a public database.
617753
Cheaper versions of biologic drugs can be made safely, a U.S. Senate panel heard on Thursday, but brand-name makers of the pricey therapies for cancer and other diseases warned substitutes could be risky.
344958
A top Republican lawmaker raised concerns about the US Food and Drug Administration&#39;s ability to monitor drug safety following Merck &amp; Co.
725572
Thailand, which has upset big drug companies by issuing patent-overriding licenses for generic versions of heart and HIV/AIDS pills, said on Monday it would issue more unless the firms cut prices.
2234
Makers of the arthritis drug Vioxx and the FDA are the subject of Senate scrutiny today...and an Iowa Senator is asking the tough questions.
312645
IN BASEBALL lingo, Senator Kennedy went one for two last week. His immigration bill went down to defeat, but the Senate health committee approved unanimously a compromise bill setting out a pathway for approval of copycat versions of high-cost biotechnology medicines. The bill balances the interests of the pioneering companies that first develop the medications -- used to treat diseases ...
732013
Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would allow drug companies to charge for the medicines.
580786
Abbott Laboratories Inc. said on  Tuesday said it is seeking U.S. regulatory approval for a drug  to treat advanced prostate cancer that has spread through the  body.
423082
A US lawmaker called on Wednesday for a probe of reports that Food and Drug Administration officials tried to discredit a veteran scientist who testified over Merck &amp; Co.
763525
Amid questions about whether the drug Vioxx was taken off the market soon enough, Senator Charles Grassley called for more safety precautions.