Since some of the drugs in short supply are often used as comparators or in combination with new therapies, the shortages are disrupting clinical trials and affecting drug development, Robert DiPaola, director of the Cancer Institute of New Jersey, said. (See BioWorld Today, May 6, 2011.) The shortages also have given rise to a largely unregulated "gray market" that is selling affected drugs at prices up to 4,000 percent more than the usual market price, Mike Alkire, chief operating officer for

For instance, health care reform legislation introduced in Poland last year would change the country's pricing, reimbursement and clinical trials policies

updating guidance documents and assessing new endpoints for clinical trials of antibacterial drugs (see BioWorld Today, June 17, 2010...Committee Wants PhRMA White House Records Trying to peer behind closed doors at the White House, the leadership of the House Energy and Commerce Committee sent the Pharmaceutical Research and Manufacturers of America (PhRMA) a request last week for information about its private negotiations with the Obama administration over the health care reform legislation

About 90 percent said the credits and grants would likely help the company advance their projects, including clinical trials, while only 1 percent said the awards would likely have no effect...Although several Republicans are calling for a repeal of the health reform legislation, Greenwood said the therapeutic discovery tax credit was a "very bipartisan effort

The Patient Protection and Affordable Care Act – the health reform legislation enacted this past spring – built on that. (See BioWorld Today, March 2, 2009, March 16, 2009, March 23, 2010, and Oct. 20, 2010.) The new law defined CER as research evaluating and comparing health outcomes and the clinical effectiveness, risks and benefits of two or more medical treatments, services and items, with those services and items detailed in the legislation's text

With this agreement, we are closer than ever to advancing patent reform legislation through the Senate," said Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), who introduced the Patent Reform Act in March 2009. (See BioWorld Today, March 16, 2009, and April 6, 2009.) If enacted, the legislation would be the first significant reform to the nation's patent system in more than 50 years...Since its inception in 1992, she said, OCI has obtained 4,392 convictions that have resulted in $9.89

The impact of the health reform legislation that cleared the House and the Senate last year would drive insurance premiums down between 14 percent and 20 percent, Sebelius insisted...The authors of the report, which included Richard Pazdur, director of the Office of Oncology Drug Products, noted that the FDA has considered overall survival (OS) as "the gold standard" for demonstrating clinical benefit

Washington Editor WASHINGTON - As the health reform legislation faces the difficult compromise road ahead during the upcoming conference process in January, little is expected to change with the measures affecting biotech, including the provisions to create a pathway for approval of follow-on biologics (FOBs...The provisions in the health reform legislation that seek to reduce costs, expand coverage and promote medical breakthroughs were "early Christmas presents for patients living with

Senate Panel Adopts Tax Credit Measure The Senate Finance Committee last week adopted an amendment that would create a tax credit for small biotechs if passed as part of the final health reform legislation...Under the provision, companies with 250 employees or less would receive reimbursements for a portion of their therapeutic development activities, including hiring scientists and conducting clinical studies

He noted that patients participating in clinical trials are paid only very minimal amounts...Beall said he doubted that clinical trials for drugs to treat rare diseases were ever considered when regulations for SSI were first conceived...If enacted, the Markey-Sterns bill would allow clinical trial participants to receive up to $2,000 per year in research compensation and remain eligible for SSI benefits.

The concerns over the cancer risk with liraglutide calls into question the size and composition of the clinical database for exenatide LAR, a once-weekly version of Byetta, and whether the makers of that drug can address agency concerns regarding the risk of thyroid C-cell carcinomas, said JP Morgan analyst Cory Kasimov...Jim Greenwood, CEO of the Biotechnology Industry Organization, said the bill that came out of the committee was a "more consensus-oriented approach to patent reform legislation

He predicted that the FDA likely would retain the authority to decide whether and what kind of clinical trials would be required, depending on the product...But Sullivan said that Obama more than likely picked Daschle for his expertise in getting health reform legislation through the Congress

An increase in research supported by the National Institutes of Health (NIH) will "yield more basic scientific findings and can also advance clinical and translation knowledge associated with the diagnosis and treatment of diseases," King said...To infuse much needed capital into the biotech industry, she added, Congress should consider capital formation tax provisions as part of an economic stimulus package and tax reform legislation, including corporate tax proposals allowing loss-making

PTO Seeks Regulatory Flexibility Input Of the controversies over recent patent reform legislation, one of the less conspicuous has been the ability of the U.S. Patent and Trademark Office to exercise regulatory discretion...He acknowledged, however, that the agency's legal personnel are spending a substantial amount of time sorting through the language of the bill, and added that "there certainly will be many areas where the agency will want to issue guidances."

Medicare reform legislation currently being negotiated in a House-Senate conference committee contains a reimportation element that would allow U.S...Pediatric Trials Legislation Hasn't Reached House Legislation requiring drug makers to run clinical trials on adult products that could be used off-label in the pediatric population made it through the Senate in July, but has yet to make it through to the House floor for a vote