Tag: industry
House Bill Introduced on Clinical Trial Database Registry
On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »
Tremendous Transactional Opportunities
For deal junkies, the next 5-10 years should be quite interesting in the life sciences/health care industry. We have already seen large pharmaceutical company consolidations, financial buyers investing in health care institutions and partnerships between payors and providers. And much of this before the Supreme Court decided that health care reform is here to stay.
What is driving this? Need, opportunity, cash and innovation. Pharmaceutical company brand drugs are losing their patent protection, the cost/risk of developing new drugs is enormous, heath care costs need to be controlled, people are living longer, health care reform is triggering new behaviors and strategies and, despite the difficult financial times, there is much cash available for investment. Also, much of the broader life sciences/health care industry has been slow in technology adoption, while technology and social media continues advancing, being available to a broader … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »