The Cross-Border Biotech Blog

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

Monthly Archives: November 2009

Supreme Court Hears Oral Arguments in False Claims Act Whistleblower Case

The United States Supreme Court heard oral arguments today in a case we noted in June in which amici curiae PhRMA and BIO urged the Supreme Court to limit whistleblower suits under the False Claims Act (FCA). Feel like you were really there by reading the full transcript of the oral argument (pdf). Out loud. In your best Supreme Court Justice Voice.

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Three Need-To-Know Canadian Patent Decisions That Impact Pharma, Biotech and Generics Companies

In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

Three recent decisions litigated in this context contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents. 

  1. The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith. In Lundbeck Canada Inc. et al  v. Ratiopharm Inc., Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe[]” the prior art in responding to an obviousness rejection raised by the patent examiner.  This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favourable and unfavourable.
  2. Formulation Patents Must Claim All Medicinal Ingredients.  In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product.  Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.
  3. Disclaimers Can Be Validly Filed After Receipt of a NOA.  In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents.  Hospira argued that the Court should consider the sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed.  Although the court held (in favour of sanofi) that the patent should be read as of the date of the hearing, it also held that sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer.  The court also held that having attempted a disclaimer, sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Thanks to Kavita Ramamoorthy and the whole Life Sciences team.

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Monday Biotech Deal Review: November 30, 2009

It was a fairly quiet week last week, but you still have options (har) after the jump, as well as an equity line, a debt settlement, a rights offering, licenses, and deals closing in a reasonably timely manner.

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This Week in the Twitterverse

A pretty quiet week for @crossborderbio on Twitter.  The first part was consumed by a tech deal of some magnitude, and the second part was U.S. Thanksgiving.  Nevertheless, a few tweets escaped:

Stay tuned this week.  Both the blog and the twitter stream will be back in full force.

Friday Science Review: November 27, 2009

Two quick reviews on studies addressing Alzheimer’s and lung damage therapy…

An ‘- omics’ Study of Lipids in Alzheimer’s Disease: Clues to the underlying molecular mechanisms of amyloid plaque proteins causing Alzheimer’s disease were revealed using a lipidomic method (think broad ‘-omics’ type profiling of lipids).  In diseased tissue, accumulation of certain isoforms or types of lipids is associated with hyperphosphorylation of the tau protein, which destabilizes neuronal cells and leads to neuronal cell death.  The researchers also demonstrated that pharmacological modulation of lipid metabolism has positive effects in protecting the integrity of the neurons and may be a strategy to prevent further decline in patients suffering from the disease.  Dr. Steffany Bennett and her research team at the University of Ottawa published the study in the Proceedings of the National Academy of Sciences.

Stem Cell Therapy for Lung Damage:  Premature newborns often suffer lung damage that leads to chronic lung disease.  However, new research using mesenchymal stem cells injected into the lungs shows promise in stimulating lung repair.  The study by Dr. Bernard Thébaud and his team at the University of Alberta in Edmonton used newborn rats as the subjects to test their hypothesis.  What is surprising is that it does not appear that the stem cells establish themselves in place of the damaged cells.  Instead, they act protectively to allow the lung to repair themselves and this may involve the release of factors from the stem cells to stimulate the regeneration process.  This strategy holds a lot of promise and hopefully the same is true in humans.  The study is a first on stem cell therapy in newborn lungs and is reported in the American Journal of Respiratory and Critical Care Medicine.

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Biotech Trends Update — Synthetic Biology: Smallest Genome May Not Provide the Best Roadmap

One of the trends we’ll be following for 2010 is synthetic biology — efforts to create entirely novel organisms and systems from “scratch.” A fundamental question in the quest to create novel life forms is what the minimal genome is that will comprise a living organism.

Scientists have been looking for, and at, existing organisms with small genomes to try to answer that question; but a series of reports on the genome of one such organism suggests they may be looking in the wrong place.

Mycoplasma pneumoniae has one of the smallest known genomes among free-living organisms — just 816,000 base pairs — so it seemed like a good candidate for understanding life’s minimal requirements. However, three Science papers this week show that the organism uses a bunch of very sophisticated tricks to squeeze a lot of function out of its small genetic pantry.

My guess is that it will be easier to deduce minimal requirements by experimenting on organisms with better characterized, though larger, genomes than by trying to decipher all the tricks of the Mycoplasma trade.

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Personalized Medicine Conference Highlights a Busy Month

Last week, Harvard Medical School held a conference entitled “Personalized Medicine: The Time is Now.”  Is the time now?  Looking around, it seems like personalized medicine has had a pretty good month:

PBMs Drive Demand

CVS Caremark, the country’s largest pharmacy services provider, partnered with Generation Health to expand pharmacogenomic testing for cancer, cardiovascular diseases, and HIV.  According the GenomeWeb story, CVS Caremark joins Medco‘s 60 million people, meaning the top two PBMs in the U.S. are investing heavily in personalized medicine.

Though note that PBMs’ interest in personalized medicine isn’t wholly neutral, as this post at IVB by Michael McCaughan points out.

Corporate Deals

Three pairs of corporations found the economics sufficiently attractive to strike new partnership deals:

NCI Investment To Advance Research

Finally, helping ensure that there is sufficient research output to advance the field, the National Cancer Institute put out a program announcement entitled “Development, Application, and Evaluation of Prediction Models for Cancer Risk and Prognosis,” which NCI says will be “essential for tailoring therapy to appropriate groups of patients.”

Counterpoint

Still, as the Washington Post notes in its article on the new “Ignite Institute” in Fairfax County: “[y]ou’d be right, of course, to be a bit skeptical,” citing decades of promise and so far few commercial successes in the region.

Bottom Line

Given this month’s developments, our Magic 8-Ball says “Outlook good.”  Stay tuned to see what develops, particularly as personalized medicine and comparative effectiveness grow in prominence at the same time.

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Monday Biotech Deal Review: November 23, 2009

A slightly delayed Deal Review this week because of some non-biotech deal activity.  Live, from New York, it’s the Deal Review!

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This Week in the Twitterverse

Tweets of the week, in case you don’t follow us @crossborderbio:

Friday Science Review: November 20, 2009

Intestinal disease genomics and how hedgehogs cause arthritis…

Genetic Clues to ‘Belly Aches’ in Children: The largest genomic investigation into early onset inflammatory bowel disease (IBD) including Crohn’s disease and ulcerative colitis involved the efforts of an international research team.  In total, genetic information from 3,400 children with IBD and 12,000 healthy children were compared.  This study resulted in the identification of five genetic regions associated with susceptibility to pediatric and adolescent IBD.  The team is now taking a closer look at these regions to try to identify the specific proteins that may explain why or how the disease develops.  Another question that they would like to address is why some individuals develop IBD early whereas others develop it later in life.  Two Toronto researchers, Dr. Anne Griffiths (Sickkids) and Dr. Mark Silverberg (Mount Sinai Hospital), contributed their expertise to the study, which appears in this week’s issue of Nature Genetics.

Colon Cancer Susceptibility Genes: In another intestinal disease research project, scientists noticed that different strains of mice exhibited different levels of resistance or susceptibility to colon cancer induced by a chemical carcinogen.  Using genetic studies, the determining factor was mapped to a specific region in chromosome 3 that they designated as colon cancer susceptibility locus 3 (Ccs3).  Within this region are about 94 known genes and they have identified a subset that are expressed at high levels in the colon.  What is also interesting is that Ccs3 in mice is homologous to regions in human chromosome 1 and 4, which also contain genes known to be associated with inflammatory bowel disease and colorectal cancer.  This mouse model will be a very useful tool for future studies on the pathogenesis of colon cancer.  Dr. Philippe Gros led the research team at McGill University and published the study in the journal Oncogene.

Hedgehogs are Key to Osteoarthritis: An unexpected discovery may hold the key to solving painful osteoarthritic disease.  Elevated expression or activity of a group of proteins called Hedgehog resulted in the development of osteoarthritis in mice.  In simple terms, the balance of this signalling pathway in chondrocyte cells determines whether they go on to make cartilage or bone.  In the animal model of osteoarthritis, Hedgehog levels are high and there is less cartilage being produced from the chrondrocytes.  Obviously, Hedgehog becomes an immediate pharmacologic target for the treatment or prevention of osteoarthritis.  You may find it strange that this study on a disease primarily affecting adults is from The Hospital for Sick Children but it just shows that research is full of surprises and you never know where it may take you!  Dr. Benjamin Alman and his research team reported their study in the online edition of Nature Medicine.

Pathway Signalling Antibody Production: A key signalling pathway required for the efficient production of antibodies was identified recently and verified using knockout mice.  A receptor on T cells called ICOS (Inducible Costimulator) is required for their conversion into a specialized type of T cell called Tfh cells (follicular B helper T cells).  As the name implies, their role is to help B cells make the right antibodies to the target.  Dr. Woong-Kyung Suh’s team at Institut de recherches cliniques de Montréal discovered that ICOS activates an enzyme called phosphoinositide 3-kinase (PI3K), which eventually leads to the release of factors that trigger the formation of Tfh cells.  With this knowledge, researchers may find ways to tweak the system to suppress (in autoimmune disease) or enhance (in infectious disease) antibody production as required.  The study is reported in the Proceedings of the National Academy of Sciences.

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New Early-Stage Funding: Ontario Genomics Institute’s Pre-commercialization Business Development Fund Calls for 2010 Applications

The Ontario Genomics Institute has a Pre-commercialization Business Development Fund (PBDF) that makes investments to fund proof-of-principle (aka proof-of-concept) programs.  They are soliciting applications for 2010 investments, with a deadline of January 29, 2010.

The project or business has to “involve genomics, proteomics, or associated technologies,” but the potential business areas are broad, including:

biofuels; cell, macromolecular, or small-molecule strategies for disease therapeutics; crop or livestock trait improvements; diagnostics; environmental management; laboratory and medical devices; nutraceuticals; and associated technologies such as analysis and organization of data resources (informatics, databases), high-throughput robotics, and information technology.

If you’re thinking about applying, you should note the following fund criteria:

  • The investment increases the likelihood of a near-term (i.e., within 24 months), ‘next-step’ event by offering concrete, definitive milestone(s) and uniquely enables rapid progress towards the marketplace for the outcome(s) of genomics-related technologies.
  • The opportunity forges a partnership between academe and industry.
  • The proposal demonstrates that the PBDF represents a unique funding opportunity for the project.
  • The applicant provides a matching investment in cash or in kind, whether from internal resources or other investors or from granting institutions.
  • The opportunity is of interest to an entity capable of and committed to further commercializing the outcome.

Caught your eye?  Here’s some diligence material

Done with that? Here are the application materials:

Go get ‘em! Good luck!

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Jeremy Grushcow Quoted by Lexpert on Social Media

Lexpert Magazine article that came out yesterday quotes our illustrious Jeremy Grushcow. The article about law firms and social media cites Jeremy’s experience using social media to facilitate real life connections between people in his network. Also featured were blawging expert Simon Fodden and his co-operative Canadian legal blog Slaw, where Jeremy contributes weekly posts on biotech highlights.

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FDA Meeting on the Internet, Social Media and Online Drug Marketing

Following some perplexing moves by the FDA, including cracking down on Google search ads, the agency convened a two-day hearing on the use of the internet and social media for online drug marketing last week.  The goal of the hearings was to seek comments from

“all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry … [in order to] help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.”

If you are interested in the topic, you can:

  1. Watch the whole thing via an archived webcast (until they take it down, but then you can read the transcript);
  2. Search #FDASM on Twitter and read the real-time reactions; or
  3. Read yesterday’s genius FiercePharma post by Tracy Staton that boils the whole thing down to a delicious executive-summary-type bite-size blurb. [See what I did there, FiercePharma headline writers?]

I highly recommend #3.

The FDA is collecting comments until February 28th (2010), after which it will digest the whole lot of them and formulate some guidance (likely) or regs (less likely) that will shape online behaviour.

P.S. Thanks LogoTwitter!

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CIHR’s Canadian Health Research Awards and Prix Galien Canada Name 2009 Awardees

Awardees were announced today for CIHR’s Canadian Health Research Awards and for the Prix Galien Canada. It’s great to see awards that cross such a broad spectrum: basic and applied research; and molecular and population-based approaches.

The CIHR awardees are:

  • Dr. Nahum Sonenberg at McGill for his pioneering work on translation control mechanisms, opening the door to new treatments for diseases such as cancer and HIV/AIDS.
  • Dr. Michael Boyle at McMaster for his work on the relationship between children’s health and their environment, and for his work to improve research techniques and methodology in this area.
  • Dr. Lynne-Marie Postovit at Western for her work on how oxygen levels and other micro-environmental signals influence the behaviour and development of normal and cancer stem cells.

The Prix Galien Canada consists of two prizes — the Research Award and the Innovative Product Award:

  • Dr. Donald Weaver at Dalhousie  is receiving the Prix Galien Research Award for his efforts to design novel drug therapies to treat chronic neurological disorders such as epilepsy and Alzheimer’s.
  • Pfizer Canada Inc. is receiving the Prix Galien for Innovative Product for Champix™ (pdf), the first in a new class of prescription medications to help people stop smoking.

Congratulations to the winners! Hope everyone had a good time in Ottawa tonight.

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Monday Biotech Deal Review: November 16, 2009

B&W_BigNickelThis week’s Canadian biotech roundup features a dose of all kinds of deals, though common shares appear to be figuring more prominently lately than they were earlier in 2009.  Lots of multijurisdictional activity too, with the U.S., the UK and Germany all participating in this week’s transactions. Other notable cross-border developments include the acquisition of IMS Health by CPP (and TPG), and Agrium’s continuing play for CF Industries.  Keep reading after the jump…

This Week in the Twitterverse

Tweets from the week – little bits of biotech goodness, reproduced here from @crossborderbio for your viewing pleasure:

Friday (the 13th) Science Review: November 13, 2009

No bad luck here in unraveling new genetic and proteomic links in disease…

Gene Variants Linked to Hearing LossA genetic link to hearing loss in children who are being treated with the chemotherapy drug, cisplatin, has been identified.  Cisplatin is a widely used anti-cancer drug but one of the harmful side effects is hearing loss experienced by over 60% of young cancer patients.  In the study by Dr. Michael Hayden’s team (Child & Family Research Institute, Vancouver), they analyzed 220 drug metabolism genes and found variants in two particular genes that are associated to hearing loss in children – one gene is called TPMT (thiopurine methyltransferase) and the other is COMT (catechol-O-methyltransferase).  With this information, doctors can perform genetic tests to determine the patient’s susceptibility to developing hearing loss and seek alternative treatment if necessary.  Further studies investigating how these enzymes contribute to cisplatin-induced hearing loss could lead to drugs to counteract these effects while receiving the benefits of cisplatin therapy.  The study appears in this week’s Nature Genetics.

The Missing Links in 5q- Syndrome: In patients with 5q- syndrome, a portion of chromosome 5 is deleted and the result is abnormal function of bone marrow cells leading to severe anemia.  We now know what is missing in this region of chromosome 5 that have key roles in maintaining the integrity of bone marrow cells.  In the investigation reported in Nature Medicine, Dr. Aly Karsan at the University of British Columbia and BC Cancer Agency discovered that two microRNAs (miRNAs), miR-145 and miR-146a, are lost in 5q- syndrome. MicroRNAs are short, single-stranded RNA that act to down regulate expression of specific target genes.  The targets of miR-145 and miR-146a are two proteins called TIRAP and TRAF6, which play important roles in immune signalling but should be turned off in hematopoietic stem/progenitor cells during blood cell development.  In support of their hypothesis, the researchers demonstrated in mice that forced expression of TRAF6 results in a condition that is similar to human 5q- syndrome.

Cancer Genes Now Linked: Researchers at Queen’s University studying C. elegans worms identified a connection between two genes involved in cancer.  PTEN is a tumour suppressor and loss of function mutations are known to be involved in a number of cancers.  Eph receptor signalling is required in developmental pathways and its expression level is elevated in some cancers.  New evidence now connects PTEN and Eph receptors in development and cancer.  The research led by Dr. Ian Chin-Sang’s team demonstrated an inverse relationship where Eph receptors can phosphorylate and downregulate PTEN.  Conversely, PTEN activity can modulate Eph receptor signaling.  If there is an imbalance in this relationship, then the (negative) effects may be amplified quickly.  The study report appears in the current issue of Developmental Cell.

Determining Thryoid Hormone Receptor Complexes in Yeast: This is a neat genetic array assay using yeast as a simple model system to unravel co-regulators in thyroid hormone receptor (TR) activity.  A yeast strain expressing TR was systematically crossed with each of 384 yeast strains bearing deletions of known genes.  From this unbiased assay, researchers identified four genes that are deemed essential for thyroid hormone function and are also conserved in humans.  Dr. Paul Walfish (Toronto Mount Sinai Hospital) and his team focused on one of these genes, CCR4.  They validated its role in thyroid hormone receptor action by performing a series of CCR4 expression and deletion analyses in cultured human cells and proved its association with TR in response to thyroid hormone.  Details of their findings appear in the early online edition of The Proceedings of the National Academy of Sciences.

FGFR3 Phosphorylation Network in Disease: An emerging field in proteomic studies is large-scale phospho-proteomic analyses using mass spectrometry to map signalling pathways.  This technique was applied to define the FGFR3 phosphorylation network in multiple myeloma and other cancers.  The researchers also demonstrated in their work the ability to quantitatively detect the upregulation or downregulation of over 60 phosphorylation sites on proteins that either responded to growth factor stimulation or inhibition by the pharmacologic drug PD173074.  One could apply this general method for pharmacodynamic monitoring of any drug inhibitor to fully understand its implications in the cell.  Dr. Michael Moran’s research team at the Hospital for Sick Children and University of Toronto published their report in this week’s Proceedings of the National Academy of Sciences.

Trends Update — IP Constituencies: Novartis CEO Vasella Calls Upcoming Gleevec Decision a “Turning Point” for R&D in India

B&W_BlankMap-World-nobordersIndia and China both ranked in the third quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 for protection of IP rights.  In an earlier post, we predicted that this ranking would change rapidly, with both countries strengthening their IP regimes as their domestic R&D capacity ramped up.

Both countries have continued to win R&D collaborations and make investments in research, most recently including an Indian R&D park project by Alexandria (a U.S. developer) and Novartis’ $1 billion investment in R&D in China

However, China and India may not be moving at the same pace.  Novartis is facing its final appeal of lower court rulings in India denying it patent protection for Gleevec, and CEO Daniel Vasella calls the pending decision “the turning point” for Indian R&D in a recent article in The Economic Times (picked up by FierceBiotech).  He also reportedly says the decision to invest in R&D in China is “not driven by its bad experience with Gleevec in India.” 

Vasella has a dog in the fight, of course, but that’s the point.  The correlation between R&D spending and IP enforcement couldn’t be clearer.

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Ontario H1N1 Swine Flu Update: November 10, 2009. 212 Hospitalized, Seven Dead.

B&W_AntigenicShift_HiResCropThis week’s Ontario Ministry of Health Influenza Bulletin shows continuing increases across all metrics. Clinic hours have expanded, and the definition of “high risk” groups entitled to be vaccinated has expanded.  Also this week, the CDC reported a cumulative total of 4,000 swine flu deaths.

The Ontario numbers continue to look grim:

  • Nine new institutional influenza outbreaks were reported
  • 212 hospitalized cases were reported from October 28 to November 4 as compared to 104 from October 21 to October 28
  • Seven deaths caused by H1N1 were reported from October 28 to November 4

Here’s the overall picture:

Ontario Swine Flu Cases Week 43

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Trends Update — Electronic Medical Records: Ontario’s New EMR Adoption Program

floppy-disk1Ontario is providing up to $29,800 per physician over 3 years for new adopters of electronic medical records.  In the few weeks since the program has been implemented, the OMA has gotten over 650 inquiries and over 150 applicants.  There’s a local option and a cloud option, which runs off the eHealth Ontario servers.  Interestingly, up to $14,400 is available for early EMR adopters who complete upgrades to the latest spec.

Some interesting features at OntarioMD try to increase the effectiveness of the implementation:

  • EMR Advisor, an Ontario-based blog that includes information, tips and case studies;
  • A transition support program;
  • A support guide; and
  • Practice management consultants (on the government’s dime).

Meanwhile, Canada Health Infoway got its own clean bill of health from the Auditor General.

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Monday Biotech Deal Review: November 9, 2009

B&W_BigNickelSome closings, some new deals, some MDS and some PBM all in this week’s deal review.

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This Week in the Twitterverse

For those who don’t follow @crossborderbio and for those who just like everything wrapped up nice and neatly in one post, here’s the Twitter news from the week.  Also, if you’re interested, I made a Twitter list of great Biopharma, HealthIT and Health twits.  Check it out here.

Bill for U.S. Domestic Production of Medical Isotopes Passed by House of Representatives

683px-Schematicky_atomThe shut-down of Ontario’s Chalk River reactor, which used to supply 30% of the world’s medical isotope requirements, and 60% of U.S. isotope needs, has prompted Congressional action in the U.S.

Yesterday, the House passed H.R. 3276 — the American Medical Isotopes Production Act of 2009 — finding that “[t]he United States should move expeditiously to ensure that an adequate and reliable supply of molybdenum-99 can be produced in the United States, without the use of highly enriched uranium.”

Both parts of that finding are important:

  1. supply of molybdenum-99 produced in the United States, because of the heavy impact on U.S. patients (16 million medical procedures annually); and
  2. without the use of highly enriched uranium, because reducing the need for highly enriched uranium is part of the U.S.’ nuclear security agenda. 

The bill would provide funding of $163,000,000 (over FYs 2010-2014) for a program to evaluate and support projects for domestic production of medical isotopes.

In Canada, the latest plan is to spin off and privatize the “reactor business” unit of Atomic Energy of Canada Ltd. (AECL).  The Chalk River reactor is facing $70 million of repairs and/or an uncertain long-term future.

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Friday Science Review: November 6, 2009

Just two stories this week – a cancer pathway and innovative dipsticks…

New Relationship between Tumour Suppressor Genes: Knocking out genes in mice believed to play a tumour inhibiting role would intuitively result in rapid cancer development.  However, it was a surprise to McGill researchers that mice lacking the tumour suppressors 4E-BP1 and 4E-BP2 were refractory to cancer growth.  When they deleted another well known tumour suppressor, p53, then they observed enhanced tumour growth more aggressive than knocking out p53 alone.  These results demonstrate for the first time a cooperative effect between 4E-BPs and p53 and highlight the advantages of indentifying individual molecular profiles to predict responsiveness to therapeutic strategies.  Dr. Nahum Sonenberg, who led the research team at McGill University remarks “this is another fine example how basic research, which intends to provide answers to fundamental questions about molecular mechanisms of cell proliferation, leads to unexpected findings that advance our ability to understand and cure human disease.”  The study appears in this week’s issue of Cancer Cell.

Bioactive Paper Sensors: A simple and rapid method to detect pesticides or toxins in food using innovative test strips was recently developed at McMaster University.  These “dipsticks” can sense the presence of small amounts of pesticides in food and within five minutes, a colour change indicates the level of the contaminant.  Future applications of this technology, with a few tweaks,  include detecting for the presence of food borne bacteria such as E.coli, Listeria, or Salmonella.  The practicality, ease of use without the need for large equipment, and the ability to get almost immediate results are huge advantages of the dipsticks to provide rapid screening and could play a role in curbing future outbreaks.  Dr. John Brennan’s team describes their research in the latest issue of Analytical Chemistry.

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Canadian Announcement on Merck–Schering-Plough Transaction Closing

Merck closed its merger with Schering-Plough yesterday, following regulatory clearance in China and Mexico.  They held press events yesterday and today, and this morning they appear to have released country-specific announcments.

Here’s the blurb on Canadian operations:

“Canada is an integral part of the company’s expanded global presence. Merck will now market over 530 pharmaceutical, consumer and animal health products, employ over 1800 people, generate over $1.2 billion in pharmaceutical sales and invest over $121 million in research and development in Canada. Merck operations in Canada include research, manufacturing, and sales.”

The Merck Canada website is still being updated.

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Trends Update — IP Constituencies: China On the Rise as an IP Enforcer

B&W_BlankMap-World-nobordersWe have been tracking increased innovative activity in India and China as part of this blog’s Trends in 2009 series, because it has the potential to impact the constituencies that negotiate the IP aspects of global trade agreements.  Generally, with this blog’s focus on pharma and biotech, posts have mainly considered commercial collaborations to develop novel products.

Two recent stories focussed on different areas highlight just how far China has come from its perceived role as a country completely neglectful of innovators’ IP:

  1. A Thomson Reuters study released yesterday shows “explosive growth in research output from China,” with output doubling since 2004.  There is no way the developments China is making in physical, biological and chemical sciences will fail to translate into innovation and new demands for IP protection.
  2. The first salvo wasn’t in biotech, as it turns out, but in copyright.  According to a recent Forbes article (H/T @TechLaw_Elman):

    A Chinese writers’ society accused Google of infringing on the copyrights of at least 570 Chinese authors by scanning and uploading their books into Google’s digital library without seeking consent.” and is “soliciting all Chinese writers to voice their opposition before a U.S. court finalizes a settlement at a hearing scheduled for Nov 9.”

Still, these developments move China much farther toward being an enforcer of intellectual property rights both domestically and on a global scale.

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Monday Biotech Deal Review: November 2, 2009

B&W_BigNickelIn this week’s Deal Review: SemBioSys hops on the SIFT Tax bandwagon; new deals from Microbix, OPMEDIC and GeneNews; and good updates from iCo Therapeutics, QLT, Noveko and Oncolytics. Read more of this post

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