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A jury in a New Orleans federal court rejected product liability claims against Merck that blamed the company’s painkiller Vioxx for the heart attack of a Utah resident.
With several pieces of legislation being considered to lower drug spending costs, lawmakers and industry sources see opportunities to overhaul federal healthcare policy to improve the generic drug industry.
As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.
One of the federal investigations into a reverse-payment deal involving generic Plavix found no violations of federal securities laws on the part of Bristol-Myers Squibb (BMS), the company said.
Separate earnings reports released by Barr and Watson show expenses and other charges related to acquisition activity were key factors that drove earnings downward for both companies in 2006.
The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.
With several pieces of legislation being considered to lower drug spending costs, lawmakers and industry sources see opportunities to overhaul federal healthcare policy to improve the generic drug industry.
A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former Centers for Medicare & Medicaid Administrator Mark McClellan, who said he is optimistic that Congress will pass legislation this year easing the entry of follow-on biologics.
Industry involvement in breast cancer trials may affect study design, focus and results, according to an article published in the online version of the journal Cancer.
A bill introduced in the Vermont Senate would allow the state to sue drugmakers for what it calls “unconscionable pricing” of prescription drugs used to treat serious public health problems.