The Cross-Border Biotech Blog

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

Monthly Archives: March 2009

Wednesday Brain Dump: Food Edition

Here’s a food edition of the Wednesday Brain Dump, but it’s all about limits:

  • Limiting Salt Intake:  A new epidemiological model predicts major benefits from minor reductions in salt intake.
  • Limiting Antibiotic Use: Some possibility that a bill, introduced in the House by Louise Slaughter (yep.), could pass, banning the use of antibiotics important to human health from being used on cattle, hogs, sheep and poultry unless animals are ill.
  • Limiting Food Imports: New rules came into effect mandating labels on most fresh meats, along with some fruits, vegetables and other foods, that will list where the food originated, and for some meat, will list where the animal was born, raised and slaughtered.  Beef farmers in border states have been pushing for the rules, which may have a negative impact on Canadian beef sales.

and the best for last…

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Anyone Else Short on Cash?

Yesterday, the WSJ Health Blog picked up on Burrill & Co.’s report, noting that one-third (120 out of 360) of publicly-traded U.S. biotech companies have under 6 months’ cash left, a figure that sounds depressingly familiar…

In the UK, the BioIndustry Association put out a press release January 27 that said:

The current situation is grave – approximately a third of publicly quoted UK bioscience companies have less than six months cash remaining. 

And here in Canada, BIOTECanada’s latest Parliamentary Quarterly (pdf) includes this nugget:

As of December 2008, over 25% of Canadian biotechs have less than 6 months cash remaining and … for smaller public companies, more than 40% have less than 12 months cash remaining. 

So please, give now.  And if you can’t spare the cash, pick up a pipette and go volunteer.  Every microlitre counts. 

Seriously, this is ugly.  Check out the Biotech Bailout page and toss an idea into the ring.

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States Step in to Ban Stem Cell Research

For those in Canada and the UK who were worried that Obama’s move to restore U.S. federal funding for stem cell research would create a 50-state mecca, I have good news:

Reuters reported yesterday that several U.S. states — Oklahoma, Georgia, Mississippi, Texas, Arizona and Louisiana – have passed or are considering legislation to outlaw some forms of embryonic stem cell research. 

For legislators in those states who voted for the bans, I have a short educational video to recommend to you:

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CV Therapeutics – Going Once, Going Twice…

Sold to the Knight in White for $1.4 billion? With Astellas announcing this morning that they will not be outbidding Gilead for CV Therapeutics, the share price dropped back down slightly below Gilead’s $20 per share offer price, indicating that investors don’t see another bidder materializing.

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We’ll See What VC

A post on Capital Rants this morning says the Mayfield Fund will be the Ontario Venture Capital Fund’s first investment, that it will be in the range of US$5 – US$7.5 million, and that Mayfield will open a one-person office in Toronto.  Mayfield’s investments page shows they invested in biotech and device plays in the past: Amgen, Genentech, Heartstream, Immunex, Intuitive Surgical, Millennium Pharmaceuticals, Orquest, Radiant Research, Sunesis Pharmaceuticals, Tularik, Velocity11 (and one cleantech company: PolyFuel). 

However, the list is sortable by categories, all of which are IT focused, and tech investments account for 145 out of the 158 listed investments.  As they say, though, past performance does not guarantee future results, so we’ll see what Mayfield does in Canada.

If Mayfield wants a glimpse at some of the Toronto community, they could check out the Entrepreneurship 101 lectures, which have recently included conversations about venture capital from the VC side and from the company side.

There’s also the recent CVCA Report (pdf), and a summary post at Capital Rants.

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Monday Deal Review: March 16, 2009

M&A:

We already noted the JLL bid for Patheon this week, and the Patheon Special Committee’s response.  It turns out that JLL has been a busy enterprise lately, extending the expiration on a bid for PharmaNet Development Group, Inc. (Nasdaq: PDGI).

Partnering:

MedMira Inc., (TSX-V:MIR, NASDAQ: MMIRF), which has been active on the securities front with a debt settlement and a private placement, announced this week that it is has established a private label partnership with Vitest AG, which plans to market and sell MedMira rapid HIV tests in Africa under the Vitest brand.

Spectral Diagnostics Inc. (TSX: SDI) announced that it has signed a license agreement with Toray Industries, Inc. of Japan, granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin™, a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream. Under the terms of the agreement, Spectral will seek FDA approval for Toraymyxin™ and intends to commercialize the product together with its Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for the measurement of endotoxin.  

Venture Capital:

The Ontario Genomics Institute, through its Pre-commercialization Business Development Fund program,  invested an undisclosed amount in Cytognomix, a London, Ontario-based developer of cytogenetic DNA probes for potential use in diagnostics.  Cytognomix is developing single cell DNA probes that are smaller and more densely distributed across chromosomes than probes that are currently commercially available, and can be designed to specifically target and detect chromosomal abnormalities, such as those underlying cancer.

AgeChem subscribed for 50,000,000 units of Advitech Inc. (TSXV: AVI) at a price of $0.02 per unit (common share plus warrants exercisable at $0.05 or $0.10).  The closing is pending Advitech shareholder approval, exchange approval, and the coversion of certain of Advitech’s debt to AgeChem into equity.

The Caisse:

Last week, the Caisse (de dépôt et placement du Québec) brought in Robert Tessier as its new Chairman.  This week, Michael Sabia was appointed as the new CEO.

Securities:

Resverlogix Corp. (TSX:RVX) announced a USD$20 million private placement, with the possibility of a USD$10 to USD$15 million follow-on round (at 20% under the 5-day VWAP at the time). On closing, Resverlogix will issue units (one common share and 0.40 of a 5-year warrant at $2.72) at a price of CDN $2.72 per Unit. The Company is relying on the financial hardship provision of Section 604(e) of the TSX Company Manual, so a fully subscribed closing cannot occur prior to March 17th, 2009. The offering is highly dilutive — 31% without taking into account exercise of the warrants and 44% assuming full exercise of the warrants. The completion of the offering is subject to the approval of the TSX and all other necessary regulatory approvals.  Also, TSX is reviewing Resverlogix’s shares with respect to meeting the continued listing requirements. Reverlogix has been granted 210 days in which to regain compliance with these requirements,pursuant to the Remedial Review Process.

Akela Pharma Inc. (TSX: AKL) and LAB Research Inc. (TSX: LRI) have reached an agreement to settle all outstanding litigation initiated by the Akela against LAB Research in October 2008. LAB Research paid CAD$2 million and issued warrants entitling Akela to subscribe to 500,000 common shares of LAB Research at a price of $0.50 per share, the warrants expiring December 31, 2010. 

Helix BioPharma Corp. (TSX: HBP) registered its common shares with the SEC.

TSX has extended its review of the eligibility of the common shares of LMS Medical Systems Inc. (TSX: LMZ) for 30 days.

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Electronic Medical Records Update: Walmart Solution, Google Problem

When we identified electronic medical records as a trend in 2009, it was before $19 billion of the stimulus was allocated to implementing EMR.  With that money on the table, the movement toward wide scale implementation has only accelerated:

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Friday Science Review: March 13, 2009

Training Brains:  Sheena Josselyn’s lab at SickKids specifically erased a fear memory in mice by selectively ablating CREB neurons using an inducible diptheria toxin.  Let me break this down, because it’s so unbelievably cool: 

  • they trained mice to be afraid of a sound,
  • then they destroyed some specific cells in the brains of the mice,
  • then the mice forgot that they were afraid of the sound.

The mice were subsequently able to learn new things, like how to find cheese in a maze, and were even able to learn to be afraid of the same sound again.  Between this and the mind-reading experiment in the UK this week, it’s enough to give you a serious bout of insomnia … which often lasts over a year, according to researchers at Laval.

Gout Rout: Dr. Hyon Choi and colleagues at the University of British Columbia reported in Monday’s issue of the Archives of Internal Medicine, that Vitamin C appeared to lower the levels of uric acid in the blood, and that men who take in more vitamin C appear to be less likely to develop gout, a painful type of arthritis.

Beef Relief: Researchers using Bioniche’s E. coli O157 vaccine, Econiche™, published a study in Foodborne Pathogens and Disease showing that vaccinated cattle were 92% less likely to be colonized with E. coli O157:H7 than non-vaccinated cattle (odds ratio (OR)=0.07, p=0.0008). This is the second published study demonstrating more than 90% effectiveness of the Bioniche vaccine against colonization.

Anti-cancer Advancers:

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Changes to Canada’s Competition Act and Investment Canada Act Become Law

Shopping for biotech assets in Canada?  Remember that changes to Canada’s Competition Act and Investment Canada Act became law on March 12, 2009 (yesterday).  Most of the changes are immediately in force, although certain changes (such as the increased Investment Canada thresholds) will not take effect until a time fixed by the Governor in Council while others (such as the new conspiracy provisions) will take effect one year from now, on March 12, 2010. Here’s the Ogilvy Renault Bulletin with the full details (pdf).

Ogilvy Renault will be hosting seminars in Toronto (March 31st), Ottawa (April 2nd) and Montreal (April 8th) to discuss the implications of these changes.  You can get details by contacting Kevin Ackhurst.

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Patheon Special Committee Bites its Thumb at JLL’s Bid. Clubs, Bills and Partisans to Follow!

Following JLL’s commencement of its bid for Patheon yesterday, Patheon’s Special Committee released its response this morning advising shareholders that JLL’s offer is “substantially undervalued, opportunistic
and structurally coercive.”

Patheon shares closed up slightly at $2.55 (up 0.79% from $2.53 yesterday), approximately matching the gains made by the Canadian dollar (up 0.55% today).  JLL’s bid is in US dollars ($2 per share), so this fluctuation with the exchange rate is to be expected.

Bonus points if you don’t need to click this to get the reference in the title of the post .

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M&A! Hooray! Genentech’s and CV Therapeutics’ Dreams Come True

Seems like $95 per share was the magic number for Genentech, which finally succumbed to Roche’s persistent advances;

and in other new news…

CV Therapeutics‘ (Nasdaq: CVTX) found a White Knight in Gilead Sciences, which will pay $1.4 billion ($20/share), topping Astellas’ $16/share offer, which CV Therapeutics rejected a few weeks ago.  Pre-market trading is over $20, though, so maybe Astellas isn’t done trying.

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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 data exclusivity

Perhaps actions South of the Border will move the ball forward at Health Canada on its regulatory pathway for biosimilars? It has been almost exactly a year since Health Canada’s draft guidance on biosimilars was published. Health Canada subsequently published a summary of its Consultation on the Regulatory Framework for Subsequent Entry Biologics following a stakeholder meeting in June.

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Wednesday Brain Dump: March 11, 2009

Regulatory Brain Dump…

Regulating Nanotech:  The FDA is collaborating with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to expand knowledge of how nanoparticles behave and affect biologic systems.  Results will be placed in the public domain.

Regulating Natural Health Products: Health Canada launched the first phase of Online Solution, a secure online system for regulating natural health products in Canada.

Not Waiting for Regulation: Like Teva’s decision in February, Momenta Pharmaceuticals doesn’t think it needs to wait for a follow-on biologics pathway.  It’s proceeding with its application (presumably still a BLA) for a generic version of Lovenox, and unlike Teva, Momenta doesn’t think the FDA will require human trials for its product.

Commissioning Regulation:  A number of reports, including the In Vivo Blog and the WSJ Health Blog have been pointing to the nomination of Margaret Hamburg as FDA Commissioner, with Joshua Sharfstein as deputy.

Self-Regulation:

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Canadian M&A Update: JLL Commences Patheon Bid at USD$2.00 per share

JLL Partners’ bid for Patheon Inc. (TSX: PTI), which has been brewing since December at the same USD$2.00 price, turned into a takeover bid today, with JLL announcing the lockup of shareholders holding 12,581,766 (about 13.8% by my calculation) of the subject shares. 

As we noted in the Monday Deal Review February 23, Patheon has cited a BMO valuation of US$4.20 to US$5.00 per share.

However, with today’s exchange rate putting the JLL offer around CAD$2.57, the current trading price of $2.53 looks like a fairly strong expectation that the bid will succeed.

Update: This is probably an opportune time to mention the Bloomberg article I saw on anti-takeover measures being implemented by public biotechs (hat tip to BIO SmartBrief, who picked it up yesterday).

Suzanne Dingwall actually made a similar point about vulnerable venture-backed public companies a couple of weeks ago.

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Bailout Update: UK and Canada

Two bailout developments to report yesterday:

In the UK, the science minister Lord Drayson is championing a call by Imperial College London and the universities of Cambridge, Edinburgh and Oxford to create a £1bn fund to finance the early stages of university spin-outs:

Medical research was given as an example, but Drayson is said to be pushing for the £1bn fund to finance ideas from all areas of science and engineering.

Here in Canada, the MaRS Blog posted yesterday about BIOTECanada’s Parliamentary Quarterly (pdf), which reiterates BIOTECanada’s previous bailout asks and includes some new data on the Canadian biotech industry, as well as some information on bailouts in other jurisdictions.

I would guess that some of the support apparently being generated by the UK proposal is due to the breadth of the project, with the potential to stimulate a wide range of innovative industries.  With so many common needs and challenges among biotech, cleantech and high tech, I would like to see further collaborative efforts in Canada as well.  Hopefully the Ontario Venture Capital Fund, which appears to be set up along the lines being proposed in the UK, will invest in all three areas and create a foundation for future collaboration.

Update: for some sense of common ground, see this NY Times blog post.

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The Face of Cod

The government has given a $3 million grant to Genome Atlantic to conduct genomic studies of atlantic cod.  This is the first part of a 4-year, $5.8 million project.  According to The New Brunswick Business Journal:

Early maturation results in a slower growth rate for the fish. That means a longer wait before harvesting, and a lower yield on the actual fillet.

By building on the results of their previous Broodstock project – which used genomics to identify the fastest growing, most disease and temperature resistant fish – researchers hope to avoid early maturation altogether. Using eggs from those elite fish, they’ll transition them into sterile eggs and then grow them to maturity.

I doubt this addresses Genome Canada’s concerns, but at least we won’t fall further behind Norway.

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SOX-Like Controls for Scientific Integrity

Yesterday, President Obama called for a restoration of scientific integrity to government decision-making in a sweeping Presidential Memorandum.  Specifically, he directed the Office of Science and Technology Policy (OSTP) to develop recommendations “designed to guarantee scientific integrity throughout the executive branch.”

Well, I have a recommendation: OSTP should use the Sarbanes-Oxley Act (SOX) as a model to create a set of internal controls and disclosure controls for assessment and reporting of the use of scientific information by government agencies.

Why?  Three reasons:

  1. The principles in the Presidential Memorandum indicate several parallels to SOX and general corporate governance requirements, as set out in the chart below
  2. Scientific information is critical as an input to govenrment decision making just as much as financial information is critical to corporate decision making, and should be treated that way, and
  3. OSTP could leverage existing governance expertise, which is key, because they only have 120 days from yesterday to develop the recommendations.

Concept

Presidential Memorandum

Sarbanes-Oxley / Governance

Oversight

The Director of OSTP is responsible for “ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological processes.”

The PCAOB was created to protect investors and the public interest by promoting informative, fair, and independent audit reports.

Competence

The selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate’s knowledge, credentials, experience, and integrity;

Not strictly part of SOX, but governance rules include the requirement for a financial expert on the audit committee.

Integrity/ Independence

Each agency should have appropriate rules and procedures to ensure the integrity of the scientific process within the agency;

Title II of SOX establishes standards for external auditor independence, to limit conflicts of interest.

Accuracy

When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards;

Title III of SOX requires that senior executives certify the accuracy and completeness of corporate financial reports.  Civil and criminal liability attaches to certifications by the CEO and CFO that the company’s public filings “fairly present in all material respects” the relevant financial information.

Disclosure

Except for information that is properly restricted from disclosure under procedures established in accordance with statute, regulation, Executive Order, or Presidential Memorandum, each agency should make available to the public the scientific or technological findings or conclusions considered or relied on in policy decisions;

This is not new with SOX.  Public disclosure has been the cornerstone of securities laws since the 1930s.

Monitor procedures

Each agency should have in place procedures to identify and address instances in which the scientific process or the integrity of scientific and technological information may be compromised; and

SOX requires certification of internal controls to ensure that any “significant deficiencies” and “material weaknesses” are addressed;  and certification of disclosure controls to ensure that “material information … is made known to management.”

Protect whistleblowers

Each agency should adopt such additional procedures, including any appropriate whistleblower protections, as are necessary to ensure the integrity of scientific and technological information and processes on which the agency relies in its decisionmaking or otherwise uses or prepares.

SOX Section 1107 contains whistleblower protections, including criminal penalties for violations.

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Patent Reform Live (Updated): Senate Judiciary Committee Hearings

You can watch the Senate Judiciary Committee hearings live here starting at 10 am.

Here’s a letter sent yesterday (pdf) by Sens. Feingold, Wyden, Bond, Brownback, Grassley, Kyl and Coburn to Sens. Leahy and Hatch expressing the writers’ concerns.

Witness list and links to the witness statements after the jump…

100th Post – State of the Blog

5 contributors, 46 days since launch, 100 posts, 544 tags, 3300 hits.* 

Thanks for stopping by!  Leave a comment; take the poll: 

* Hits as in page-views.  Don’t assume stuff just because we’re in Canada.

Restoring Scientific Integrity to Government Decision Making

In addition to Obama’s announcement today lifting the ban on federal funding of stem cell reasearch, he also issued a presidential memorandum

To ensure that in this new Administration, we base our public policies on the soundest science; that we appoint scientific advisors based on their credentials and experience, not their politics or ideology; and that we are open and honest with the American people about the science behind our decisions.

To which I can only say: thank goodness. 

Read the full memorandum after the jump…

Merck and Schering-Plough in Canada

Following this morning’s announcement of Merck’s offer for Schering-Plough (0.5767 share of Merck and $10.50 in cash for each Schering-Plough share = $23.61 a share, a 34% premium, with Merck shareholders owning 68% of the combined company), we thought we’d take a look at the respective Canadian operations.  See what we turned up after the jump…

Monday Deal Review: March 9, 2009

A big dose of Canadian deals and company info from this week after the jump…

Canadian Budget Reaction Boils Over

A meeting this week between the Canadian Association of University Teachers and Gary Goodyear, Canada’s Minister of Science and Technology descended into a shouting match over cuts to research funding announced in Canada’s 2009 federal budget.

Interestingly, the Minister focused on a point I made last week – that the Canadian approach lately has centered on commercialization:

Mr. Goodyear, a chiropractor from Cambridge, Ont., said the government has been steadily investing in science and technology since 2006, with a new emphasis on commercialization…

I think commercialization is a worthwhile investment; but funding commercialization at the expense of Canadian research is a major  blunder, for the following reasons:

  1. There is no commercialization without research.  Researchers from Boston or San Francisco or Edinburgh will not suddenly move here to start their companies because of extra NRC-IRAP funding.  If the developments aren’t made here, the companies won’t be formed here either.
  2. Research is an area in which Canada punches above its weight.  Check out our Friday Science Reviews and you will see international headlines and top tier journal articles.  However, a lot of hard reputational work is undone by the kind of international reaction generated by the 2009 budget.
  3. The timing is bad.  The increased research funding provided by the U.S. budget and stimulus makes for a terrible comparison.  Plus, Obama is poised to lift the U.S. federal funding ban on stem cell research tomorrow (Monday); and this is an area where we have benefited from an extra structural advantage that is about to be erased (as observers in the UK have already noted).

So, Mr. Goodyear, by all means focus on commercialization.  We can (and will) quibble about that implementation another time.  But in the meantime, restore the research funding that makes us a world-class producer of scientific innovation.

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Roche-Genentech Update

Roche raised its bid to $93 per share, more than the $89 per share it started at, and considerably more than the $86.50 per share it had been proposing lately.  No substantive response yet from Genentech’s special committee.  Keep your eyes peeled for a new SEC filing here.

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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 on sourcing technology from non-U.S. partners.

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Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and PalloneWe did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

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Friday Science Review: March 6, 2009

Cool Canadian science stories this week…

Stem Cells: The big Canadian science news this week was the report by Dr. Nagy’s lab at the Lunenfeld that they have found a much safer way to make pluripotent stem cells from adult tissue.  Their publication (co-authored with Keisuke Kaji’s team at the University of Edinburgh) appeared in Nature this week.

Also on the stem cell front, Dr. Kremer, the co-director of the Musculoskeletal Axis of the Research Institute of the McGill University Health Centre, used Interferon gamma to induce the differentiation of mesenchymal stem cells into osteoblasts in vitro, and that IFNγ knockout mice also show reduced bone density and that isolated mesenchymal stem cells from the knockout mice show a differentiation defect.  Long story short: a potential new target for improving bone density.

Clinical Trials: Good news for GSK and for scientists at McMaster University, who showed that GSK’s Mepolizumab (pdf), an anti-IL5 humanized antibody that blocks eosinophil production, helps severe asthmatics improve asthma and reduce their need for prednisone by close to 90 per cent, a result that was seconded by a group in the UK.

Nanotechnology Costs: We noted a few weeks ago that there were changes coming to nanotechnology regulatory environment, and now researchers in BC and Minnessota estimate that testing the toxicity of existing nanomaterials in the United States could cost between $249 million and $1.18 billion and that full-scale testing could take decades to complete. They propose a tiered approach, similar to the EU’s REACH program for testing toxic chemicals, to define priorities.  Hat tip to ScienceInsider.

Hosted Services: Canadians, being hospitable types, are hosting World Diabetes Congress in Montreal in October, as well as a new Occupational Cancer Research Centre – charged with “improving knowledge and evidence to help identify, prevent and ultimately eliminate exposures to cancer-causing substances in the workplace.”

Musical Chairs: A group at Ryerson University’s centre for learning technologies in conjunction with the science of music, auditory research and technology (SMART) lab have developed a chair that allows the hearing-impaired to experience music by using the skin as a hearing membrane. 

Global Issues: An Amazon drought caused a major release of carbon dioxide; but don’t worry, because we’ll find a new planet in no time.  Sound painful? Don’t worry – a spoonful of sugar really does help the medicine go down.

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Trends in 2009: Personalized Medicine and Cancer Update

The Boston Globe reported this week on current trends in genetic testing of tumors:

  • Massachusetts General Hospital will be adding $2,000 per patient worth of genetic testing as part of its standard of care for cancer.
  • Dana-Farber tests selected patients, including patients with certain melanomas, where doctors know those malignancies can carry abnormalities that are susceptible to certain drugs.
  • Memorial Sloan-Kettering Cancer Center in New York, will start screening most patients with lung cancer within weeks.

This week has seen some scientific developments reported in tumor screening as well:

  • A study in PNAS reports on an analysis of genome-wide expression and copy-number data in endometrial cancers and finds a couple of prognostically-relevant results.
  • A study in the Journal of Clinical Oncology reports on the use of a 50 gene array to successfully identify four breast cancer tumor types that have been previously defined: luminal A, luminal B, HER2-enriched and basal-like.

We’ll see if the accumulation of data is sufficient to make a case for insurance coverage.

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Wednesday Brain Dump: March 4, 2009

Monkey Business: glycerol monolaurate (GML), a well-known microbicide, may protect macaques against SIV; but future experiments may need to use a modified HIV strain instead; meanwhile, who will protect them from the University of Louisiana? 

Smoky Business: the tobacco industry is facing new litigation in Ontario, and FDA regulation in the U.S.

Actual, Honest-to-Goodness* Profitable Business:  The Burrill report marks this year as the first one to show an overall profit from the biotech industry.

*well, sort of.

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Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf.

Now we have different preemption rules for PMA-approved devices (Reigel v. Medtronic), where state tort law is preempted, than for 510(k) devices (Medtronic v. Lohr) and for drugs (Wyeth v. Levine) where state law claims are still available.

Let’s see where Waxman and Pallone head with this.

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