The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Category Archives: Dani Peters

Senate Action on Small Business Innovation This Week?

The Senate schedule for today does not include consideration of The Small Business Innovation and Research Act of 2009. Late last week there were rumors the House version of legislation, passed by the U.S. House of Representatives on July 8, would receive expedited consideration on the Senate floor as early as today, using the unanimous consent Senate measure. The [...]

Obama Budget 2010: HHS Highlights

The Obama Administration delivered its FY2010 Budget to Congress yesterday. Among the highlights of the Department of Health and Human Services Budget: $511,000,000 increase to FDA’s budget with $259 million for food safety inspections, surveillance etc. $584,000,000 for influenza preparedness, including purchase and development of vaccines, antivirals, diagnostics and supplies $275,000,000 for advanced development of biodefense [...]

Health Care Reform: Party’s Over for Medical Imaging

Well…it could be worse, but one could argue it’s the beginning of a slow decline for the medical imaging market in the U.S.  On Tuesday, Senator Baucus (D-Montana) and Senator Grassley (R-Iowa), Chairman and Ranking Member of the Senate Finance Committee, released a description of policy options for healthcare reform.  The options included “Transparency and Evidence-Based Decision-Making for Imaging Services,” proposing a [...]

BioFinance Lunch Keynote: U.S. Health Reform

Just finished listening to Scott Gottlieb at the BioFinance lunch keynote. Scott was Deputy Commissioner at the FDA in the Bush administration, and is now a Fellow at the American Enterpirse Institute. Here’s what he had to say. Stay tuned for questions from the audience, including Dani and I, at the end… Healthcare in the [...]

The Week Ahead: FTC Hearing on “Evolving IP Marketplace”

The Federal Trade Comission will be hosting a public hearing this Friday on the “The Evolving IP Marketplace: Markets for Intellectual Property”.  This is part of series of public hearings the FTC has held around changes in intellectual property law, patent-related business models and the new IP marketplace.  Looking at the agenda, I was surprised to [...]

About the Delayed Sebelius Confirmation

Contrary to expectations, Secretary of HHS-designate Kathleen Sebelius did not receive her Senate confirmation before the Congressional recess on April 3, due to the objection of one Senator.  Is Sebelius using the break to make greater assurances to Republican lawmakers before her vote is taken up again during the week of April 20?  In her confirmation hearing, Sebelius [...]

The Week Ahead on Capitol Hill

HHS-Secretary elect Kathleen Sebelius will have confirmations before the Senate Health, Education, Labor and Pensions Committee on Tuesday, March 31, followed by the Senate Finance Committee on April 2.  Both hearings should cover topics such as universal health care and comparative effectiveness.  The first hearing would also address issues like public health preparedness and health innovation, [...]

Waxman Drives Hard Bargain on FOBs Market Exclusivity

Representatives Waxman (D-CA), Pallone (D-NJ) and Deal (R-GA) released the Promoting Innovation and Access to Life Saving Medicine Act today, a.k.a. Follow-On Biologics legislation. The legislation provides a five-year initial exclusivity for products with a unique molecular structure. The Biotechnology Industry Organization is not too happy. In the past BIO has called for a 14-year [...]

Stimulus Funding from NIH!

On Wednesday the National Institutes of Health published its Request for Applications (RFA), allocating $200 million provided in the American Recovery and Reinvestment Act.  The deadline for submissions is April 27, and requests for funding cannot exceed $1 million over two years. Applications must come from U.S. institutions and organizations, but  there are no apparent restrictions [...]

The Patent Reform Act of 2009: Absent Inequitable Conduct Provisions Help Biotech

The Patent Reform Act of 2009 was introduced by Senator Patrick Leahy (D-VT) Chairman of the Senate Judiciary Committee. The bill includes Senator Orrin Hatch (R-UT) as a co-sponsor. Notably missing from the list of co-sponsors is Senator Arlen Specter (R-PA), Ranking Republican on the Judiciary Committee. Provisions relating to inequitable conduct have been removed [...]

Obama, Sebelius and Drug Importation

The President’s Budget released last week highlighted President Obama’s support for importing cheaper drugs from Canada (pdf).  The Washington Post writes that Governor and HHS Secretary-elect Kathleen Sebelius was successful in having Kansas join a multistate consortium that allowed Kansans to order prescription drugs from Canada, Britain and Ireland, often at a lower price than in [...]

More Money: House of Representatives Release 2009 Spending Bill

The U.S. House of Representatives Appropriations Committee unveiled its Omnibus spending bill for Fiscal Year 2009 yesterday (pdf). The House is expected to vote on the package this week. For Health and Human Services, the Ombnibus contains $30 billion for the National Institutes of Health (NIH). This funding is in addition to the $10 billion [...]

Sibelius and Biotech

Yes, we have all heard the rumors about Kansas Governor Kathleen Sibelius as the next HHS Secretary. How will the potential Secretary Sibelus impact the biotechnology industry? In her first term, Sibelius signed into law the Kansas Economic Growth Act, which was seen as a way to boost Kansas’ biotechnology industry. The Act allocated $500 [...]

U.S. Stimulus Compromise (Updated)

Initial reporting (NYT, WSJ) on the bill coming out of the House-Senate conference committee this evening indicates that the $789 billion package will include most of the Bio-related provisions: It keeps the additional $6.5 billion for the NIH that was in the Senate version; The $1.1 billion for Comparative Effectiveness is also still in; and [...]

Senate Stimulus: Good and Bad Outcomes for Funding Biotech

The latest Senate deal provides an extra $6.5 billion to NIH, amounting to $10 billion for biomedical research but also to improve research infrastructure in NIH facilities. According to Senator Arlen Specter, Ranking Republican on the Senate Health and Human Services Appropriations Subcommittee, the monies would be divvied up among NIH agencies in amounts proportional [...]

Flu and Stimulus

With new reported cases of avian flu in Canada and China  it’s encouraging to see that the U.S. economic stimulus plan boosts funding for development of vaccines and antiviral treatments for pandemic influenza.

Update on U.S. Biotech Bailout

Yesterday the U.S. House of Representatives’ Ways and Means Committee approved the “American Recovery and Reinvestment Plan,” (pdf) which did not include tax stimulus incentives proposed by the biotechnology industry (namely monetizing future Net Operating Losses and future R&D tax credits now in order to forgo those tax assets in the future). The U.S. House [...]

Threats in 2009: Patent Reform

The United States Congress is expected to take up patent reform legislation again in 2009. For biopharma companies, it is safe to say that last year’s version of the bill would not bode well for industry innovation and investment.

Trends in 2009: Comparative Effectiveness and Personalized Medicine

Two potentially conflicting trends may see a dramatically increased profile in 2009: Government Bailouts and Free-Market Capitalism Comparative Effectiveness and Personalized Medicine. Both have been highlighted by the incoming Obama administration. 

Follow

Get every new post delivered to your Inbox.

Join 84 other followers