The Cross-Border Biotech Blog

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

Monthly Archives: February 2009

Stimulus Bill Originalism

Here’s where you can get the text of the conference report, if you’re in the mood.  At over $1 billion per page (780 pages, $789 billion), it should be good reading. We compiled information on allocations to science in the stimulus bill earlier in the week.

Friday Science Review: February 13, 2009

More Info on Canadian Electronic Medical Records Implementation

In our Trends in 2009 series, we noted that Electronic Medical Records are poised to make significant inroads this year in Canada and the U.S. Yesterday, Leona Aglukkaq, Canada’s Minister of Health, confirmed that: Funding of $500 million announced today is in addition to $400 million in support provided to Canada Health Infoway in Budget [...]

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 [...]

Wednesday Brain Dump: February 11, 2009

Deep Appreciation:for Phillip Terrence Ragon, founder and sole proprietor of database-software provider InterSystems who donated $100 million to establish a research institute that focuses on expediting the development of an AIDS vaccine, and to Pfizer Canada which contributed a further $2 million to British Columbia’s Center for Drug Research and Development (CDRD); and The State [...]

Trends in 2009: Genetically Engineered Animal Approvals

The past few weeks have seen at least three conspicuous developments towards a functional regulatory regime that will lead to increasing numbers of FDA approvals for Genetically Engineered (GE) animals: The FDA released their final Guidance on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (pdf), as well as a FAQ and comment responses. The FDA approved ATryn, a [...]

Personalized Medicine: First SAEC Data

The FDA (as part of the Critical Path Initiative) and the International Serious Adverse Event Consortium (SAEC) announced the release of their first data on the genetic basis of adverse drug reactions today.

M&A Update

Following our last update, there have been a considerable number of bio/pharma M&A developments, so to bring you up to speed

Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with [...]

Monday Deal Review: February 9, 2009

Biotech Bailout: France Edition

Unlike their research couterparts, who threw shoes in protest, France Biotech is taking a more traditional approach to their asks, starting with some grim statistics on private investment in French biotech in 2008:

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 [...]

Friday Science Review: February 6, 2009

Could Have Been Worse

It doesn’t look like the budget announcement in Canada was quite as bad as the one in Austria, but here’s one Government Relations strategy we haven’t tried yet…  And if that fails, we could always throw shoes.

Introducing…

Beni Rovinski of Lumira Capital joined the blog today.  Beni is a Managing Director focused on US and Canadian mid- to late-stage private and public companies involved in drug discovery and development, biological and small molecule therapeutics, drug delivery and specialty pharmaceuticals.  Take a look at his full bio here.

Electronic Medical Records and Public Health

Here’s one electronic records initiative that looks good as cost-savings and doesn’t seem too controversial from a privacy perspective: …as the province moves toward electronic health records, Dr. Barbara Yaffe,  Toronto’s associate medical officer of health, said she wants children’s immunization charts to be included. …By law children in Ontario must be vaccinated against measles, mumps, [...]

Trends in 2009: Electronic Medical Records

EMR got a boost in Canada’s budget, and is getting traction in the U.S. as well.  In Canada, EMR initiatives are likely to be implemented by the Provincial health plans directly, with back-end services from a variety of vendors.  In the U.S., the ultimate structure is less clear.  Google has tried to get ahead of [...]

Wednesday Brain Dump: February 4, 2009

Some good news on the gene therapy front in adenosine deaminase-deficient SCID patients and in rheumatoid arthritis. But mostly bad news on the job front at GSK, AstraZeneca,  Abbott,  GenVec, Patheon, and others. Other good news on the approvals front for Parusgel (despite process concerns), Kapidex, Lamictal, Gelnique and Taxus Liberte. Really small news: Nanomaterials may be heading for [...]

Funding Gap?

A perennial question: is there a gap in available funding for startups? Some cool data from Lumira Capital’s latest newsletter (pdf) compares VC funding in the U.S. and Canada using the traditional 10:1 baseline expectation.  By this measure, Canada’s gap is in late-stage VC funding; but in light of the across-the-board drop seen in Q4 investment [...]

Canada’s Budget: An Innovation Shortfall

A good piece by David Crane in the Toronto Star today that touches on the BIOTECanada and Genome Canada issues, as well as a broader indictment: There are some initiatives in the budget that will help. But overall it falls far short of what is required for an innovative economy, one that will deliver the [...]

It Might Rain M&A at Merck Too

Following actual deals and expressions of interest by most of his peers, Merck’s CEO said he wouldn’t rule out a large transaction.

It’s Raining M&A: Update

Canadian developments first: MDS (TSX:MDS; NYSE:MDZ) announced that it’s forming a special committee to “support the Company’s continuing process of reviewing alternatives to improve shareholder value.”  According to the press release: The committee is comprised of William Anderson, Robert Luba, James MacDonald and Gregory Spivy, each of whom is independent of management. James MacDonald will [...]

Biotech Bailout: Israel Edition

Israel’s Ministry of Finance announced a two-part stimulus for high-tech and biotech companies.  The first part is an additional infusion of NIS 150 million (US$37 million) for the Office of the Chief Scientist, which runs a variety of R&D and commercialization programs.  The second part is NIS 250 million (US$61 million) to set up a [...]

Monday Deal Review: February 2, 2009

Canadian deals we found this week:

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