The Cross-Border Biotech Blog

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

Monthly Archives: February 2009

Allocating Spending to Support R&D: UK, U.S. and Canadian Approaches

The U.S., Canada and the UK have all acknowledged the central importance of R&D even in these recessionary times.  However, the three national governments have decided to focus their spending on different steps of the R&D equation: Education: UK Takes the Long View British PM Gordon Brown, in a speech this week, identified three priorities: research, education and training, [...]

Friday Science Review: February 27, 2009

Cool Canadian science developments this week: How life evolved: Two biochemists at University of Montreal solved the mystery of Ribosome self-assembly, and published it in Nature (subscription required). How we learn: SickKids researchers made knockout mice that have spatial learning and memory defects, but the genetic defect can be fixed by an experimental Alzheimer’s drug.  [...]

GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute.  AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014. The double combo shot:  the success of the collaboration depends on [...]

Bright Spot for Canada in NIH Gains?

You may not know this, but Canadian researchers can compete for NIH extramural funds, and they do so quite successfully.  I reviewed the 2008 data from the NIH budget site, which shows that Canadian researchers were awarded $47.4 million in 2008 (out of a total of $212.4 million total awarded outside the U.S.).  Hopefully this [...]

J&J and Basilea to Arbitrate

In case you hadn’t heard, Basilea filed a claim for arbitration under their license agreement with J&J for the antibiotic ceftobiprole, based on the anticipated news, confirmed today, that the the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections. Brian Orelli has a nice post up on the [...]

EEOC Meeting Kicks off GINA Comment Period

Last year, the Genetic Information Nondiscrimination Act (GINA) became law in the U.S.  Among other things, GINA prohibits discrimination by health insurers and employers based on people’s genetic information, prohibits the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements.  The U.S. Equal Employment Opportunity Commission (EEOC)  is charged with issuing [...]

Wednesday Brain Dump: February 25, 2009

The question this week: a shot in the arm or a kick in the teeth? A shot in the arm for: Fewer shots in the arm! (har)  British Columbia is the first jurisdiction in North America to offer a children’s vaccine called Infanrix-hexa™, which contains six immunizations in one, resulting in three fewer needles 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 [...]

From Here to Osgoode and Back Again

IP Osgoode just linked to the Cross-Border Biotech Blog as the “IP Pick of the Week” this week.  Thanks Rex! The Osgoode IP Law and Technology program is hosting a conference on March 20th entitled “Commercialization of innovative research: Implementing solutions that work for Canada.” Paul Carenza, a colleague of mine at Ogilvy Renault, is speaking [...]

The Edison Awards: An Opportunity for Ontario?

In the context of some discussion about the Canadian federal budget, I had blogged about the idea of “an Ontario-based commercialization award of international scope, like the Gairdner Awards, that would seek out and reward internationally outstanding achievement in entrepreneurship.” A press release from Nuvo Research Inc.(TSX: NRI), a Canadian drug development company focused on topical and [...]

Exciting Day Today

A couple of fun events are bracketing my day today.

Warfarin and Personalized Medicine

The optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic [...]

Being Organic Means Never Having to Say You’re Cloned

The Globe and Mail carried an article last week about the revised Organic Product Regulations that will come into effect in Canada on June 30, 2009. The Organic Product Regulations (as they did in 2006) incorporate by reference the Canada General Standards Board CGSB 32.310 Standards, and it’s those standards that were amended October 1, 2008 to [...]

Monday Deal Review: February 23, 2009

Canadian deals and company info this week

M&A Update 2

Here’s the latest collection of M&A news we’ve found since the last update.  No new mega-deals, although Sanofi is shopping in the €15 billion range and Roche sold $16 billion of debt (which has seen high demand in subsequent trading) in the largest offering ever to raise cash for its Genentech bid.  Also, CV Therapeutics‘ (Nasdaq: CVTX) Board [...]

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 [...]

More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week – that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. [...]

Friday Science Review: February 20, 2009

Cool Canadian science stories this week… A University of Ottawa Heart Institute (UOHI) research team showed that a DNA sequence variant facilitates rapid weight loss in people who are dieting by increasing the activity levels of ACSL5, among the first genes associated with weight loss. The study was published in FASEB J. The results of [...]

Teva Decides Not to Wait for U.S. Biosimilars Legislation

In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime. Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their [...]

Device Liability Preemption: Blunt v. Medtronic

In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models.  Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the [...]

TBI Breakfast: BIO and Biotech in the State of Georgia

I just came back from a very enjoyable TBI Breakfast with talks by Carol Henderson, the Director of the Georgia Department of Economic Development and Graeme McRae, the Chairman & CEO of Bioniche Life Sciences, Inc. which has an Animal Health division facility in Athens, Georgia. Graeme’s talk, as usual, was very interesting and not very print-able. Carol’s talk [...]

NIH Stimulus Spending

Some good info from ScienceInsider about how NIH is planning to allocate the stimulus money.  It looks like the vast majority will go to existing grants and already-submitted applications.

Wednesday Brain Dump: February 18, 2009

Good thing I waited until evening, because this week’s post is mammoth.  Funny, right?  So funny, this post may go viral… The Nipah virus may be stopped more easily than expected and a vaccine for Dengue may be at hand. MRSA infections are on the decline and a vaccine for Clostridium difficile may be on the way. [...]

Ups and Downs for Biotech Crops in the EU

Quite an a-maize-ing week (sorry) for biotech crops in the EU: The European Commission announced a proposal to end Austria’s ban on biotech maizes MON810 and T25, saying that Austria had not supplied scientific evidence that the specific nature of Austria’s ecology justified the ban. A report from the French food safety agency, Afssa, saying MON810 [...]

Biotech Bailout: Maryland Ask

At a news conference yesterday reported in the Washington Business Journal and picked up by BIO SmartBrief, a group in Maryland expressed their hope that Maryland’s biotech tax credit program, under which investors receive a tax credit equal to 50 percent of the money they spend would get the $6 million boost to $12 million initially [...]

Biotech Bailout: Texas Edition

Texas Governor Rick Perry keynoted a conference yesterday on “the challenges and the future of biotechnology in Texas” and “told the group that the biosciences are ‘the next big thing in the global economy.’” According to the article in today’s Star-Telegram, the Texas Healthcare and Bioscience Institute is encouraging a number of measures this legislative session for [...]

Personalized Medicine: The “SNP Doctor”

BIO SmartBrief picked up a story today about a device being tested called the mohel Snip Doctor, a hand-held diagnostic device that: looks for known single nucleotide polymorphisms (SNPs) – single letter changes in the genetic code – that can affect an individual’s response to medical treatment. While most current approaches to personalized medicine are mechanistic (e.g., [...]

Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market

The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, [...]

Comparative Effectiveness Stimulus Stimulates Reactions

The $1.1 billion in the stimulus bill for comparative effectiveness research has, not surprisingly, generated a good deal of public attention.  Friday’s Washington Post and the front page of today’s New York Times both have stories covering the political jockeying. Although both pieces focus on potential problems from the lack of individualization, either from libertarian or [...]

Monday Deal Review: February 16, 2009

An interesting collection of goings-on in this week’s special President’s Day / Family Day edition of the Monday Deal Review

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