The Cross-Border Biotech Blog

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

Category Archives: News

Approval Pathway for Biosimilars and Interchangeable Biological Products: Issues from the FDA’s Public Hearing

On November 2nd and 3rd the FDA held a public hearing to address the challenges it will face in the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This act established an abbreviated pathway for follow-on biologics (a.k.a. biosimilars) that are either “highly similar” or “interchangeable” with previously approved biologics. [...]

Stem Cell Breakthrough: Direct Conversion of Human Skin to Blood

A breakthrough in Canadian stem cell research this week, published in Nature, as researchers led by Dr. Mick Bhatia of the Stem Cell and Cancer Research Institute at McMaster University have devised methods to differentiate human skin cells into blood cells. In many differentiation protocols researchers are forced to first reprogram cells to a pluripotent [...]

U.S. Therapeutic Discovery Stimulus Reaches Biotechs in Canada, Israel, Germany

As part of the health reform bill, the U.S. launched a $1 billion Therapeutic Discovery Project tax credit/grant stimulus program. The program announced grant recipients this week, deploying $1 billion just over 7 months after the law was passed, and 5 months after the IRS guidelines were released implementing the project. A full list of [...]

Two MaRS Innovation Transactions Take Off

MaRS Innovation, the “integrated commercialization platform” responsible for commercializing inventions from 16 Toronto academic institutions, announced two deals last week. One spin-out and one out-license (pdf links). The spin-out: MI put $500,000 into Prof. Shana Kelley‘s new company, Xagenic, alongside a $300,000 loan from HTX; $200,000 from the Ontario Institute for Cancer Research; and $40,000 from [...]

Biotech Trends Update — Biosimilars Blur IP Constituencies: Novartis and Pfizer-Biocon are Featured in the Economist

Two 9-figure announcements this week mark a turning point for the biosimilars market, and one highlights the increasingly important role India plays in innovation. Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in development of four biosimilar insulin products that gives Biocon $200 million up front. Coverage of [...]

Biotech Trends Update — Personalized Medicine: Duncan’s Personalized Health Manifesto is Primarily Preventative

Journalist David Ewing Duncan’s “Personalized Health Manifesto” was published this week by the Ewing Marion Kauffman Foundation. The most interesting thing about the manifesto* is that it assumes that the technical hurdles to generating and understading a full set of personalized health data have been overcome, and focuses on how that information can be deployed [...]

Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were [...]

Canadian Venture Capital Data from Q2 2010 Shows Big Jump From Q2 2009 but Only Moderate Increase for Biotech

The Q2 issue of Industry Canada’s Venture Capital Monitor is up, and it shows “the highest level of VC activity since Q3 2008,” though that is still “significantly lower than the quarterly average of $440M recorded over the previous five years before the downturn.” A couple of (particularly) parochial notes: First-time deals at the seed and [...]

More OETF Investments Announced, Including NeurAxon

The Ontario Emerging Technologies Fund got off to a bit of a slow start on the life sciences front, but last month it added Lumira and CTI Life Sciences as qualified investors. Now, CTI has taken advantage of that status with OETF participating in a $14 million round of convertible debentures issued by NeurAxon, along [...]

Why Technology Transfer Offices Should Focus on Sponsored Research and Ignore Royalties: In Praise of UNC’s “Express License”

A story by Xconomy’s Sylvia Pagán Westphal yesterday highlights a new approach to technology transfer licensing being taken by UNC Chapel Hill’s Office of Technology Development: The Carolina Express License. At first glance, the agreement looks, as Westphal puts it, “not very sweet for the university.” UNC takes 0.75% of any exit transaction, but no equity, no milestones [...]

Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

Adam Feuerstein at TheStreet.com reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation. The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure [...]

Flow-Through Shares for Biotech: Welcome to National Biotechnology Week in Canada

Tomorrow is the first day of National Biotechnology Week in Canada. The imagenation.ca website has lots of info, and you can follow @BIOTECanadaNBW on Twitter. One of this year’s big policy initiatives is a push to expand Canada’s Flow-Through Shares program from mining and wind power to include biotech and other cleantech companies. I gave [...]

Agricultural Biotechnology International Conference (ABIC) In Saskatoon This Week Highlights Canada’s Strength in Ag-Biotech

The ABIC conference in Saskatoon this week is highlighting Canada’s strength in the field (har). Canada has world-class resources to compete: plenty of arable and marginal land, and bushels (sorry) of know-how and innovation. Two Canadian announcements of note at the conference: Saskatchewan’s Premier, Brad Wall, announced $5 million over 4 years for ag-bio projects. The [...]

Ontario Emerging Technologies Fund (OETF) Shows Signs of Life (Sciences), Adds Biotech Investments and Investors

An announcement this morning from the OETF — Ontario’s (née) $250 million co-investment fund – shows positive signs for potential matching investments in the life sciences. First, the OETF announced an investment in Natrix Separations. BDC wore the “Qualified Investor” hat on that one, but Natrix is in GrowthWorks’ Canadian Fund portfolio, so we know at [...]

FedDev Ontario is Feeding $45 million Through NRC-IRAP to Support SMB Innovation

During a visit to Sernova (TSXV: SVA) today, Gary Goodyear* announced that $45 million of FedDev Ontario money will be deployed through the NRC’s Industrial Research Assistance Program (IRAP). IRAP has been a relatively effective vehicle for funding life science companies and has taken a prominent role since having been allocated $200 million in the 2009 federal [...]

Q2 Canadian Healthcare Review Shows Biotech Financing Weakness but Some M&A and Regulatory Wins

Data in the Q2 2010 Canadian Healthcare Review from the Equicom Group (co-authored by James Smith, Vice President Healthcare at Equicom and myself) shows a continuation of the weakness in biotech financing that was outlined in last week’s Toronto presentation of Ernst & Young’s Beyond Borders global biotech report. The public Canadian development stage companies raised [...]

E&Y Beyond Borders Biotech Report 2010 — Canadian Biotech Data

I went to Ernst & Young‘s Toronto presentation of this year’s Beyond Borders global biotech report (pdf) this morning. The report is a retrospective of 2009, so many of the data points and trends reflect things you’ve seen already; but as always, I’d encourage you to read the whole thing for good synthesis and commentary. E&Y’s [...]

Key Quotes from the U.S. Supreme Court’s Decision in Bilski Shows No Current Impact on Biotech

Many expected the U.S. Supreme Court’s decision in Bilski to have a far-reaching impact on methods patents, including biotechnology diagnostics and drug development. That turned out not to be the case, with the Court deciding on narrow grounds that the actual patent at issue was improperly granted and reminding the Federal Circuit that it prefers [...]

Health Canada’s Pharmacovigilance Program Provides Consumers with (Consumer-Unfriendly) Form for Direct Reporting of Adverse Effects

Health Canada added a potentially valuable pharmacovigilance tool to its post-market surveillance arsenal today — a web form for direct consumer reporting of adverse drug events. Unfortunately, the implementation is terrible. The goal was “to make it even easier for consumers to report side effects to drugs and other health products,” but I doubt most consumers [...]

Biotech’s Murky IPO Window Increases M&A Attractiveness

A recent press release from Burrill & Company points out that only 1 of 8 U.S. biotech IPOs in 2010 is currently trading above its IPO price. IMRIS was the last Canadian biotech IPO, completed in November 2007 at $6.00, and it is currently trading at $5.50 after dipping under $2 in late 2008. Facing these [...]

Welcome to New Cross-Border Biotech Blog Contributor Wayne Schnarr

I am very excited to introduce Wayne Schnarr as a contributor to the Cross-Border Biotech Blog. Wayne has a ton of industry experience and always has smart things to say, as you will see for yourselves in a minute. Welcome!

Patent Cliff Will Not Save Biotech: Abbott Buys Indian Generics Company Piramal Healthcare

I often hear how the upcoming loss of patent protection for current blockbusters creates an insatiable demand at pharma companies for new pipeline products from biotechs. Here’s an example from 2007. Here’s one from last week. This is not true. Upcoming loss of patent protection creates a insatiable demand for revenue, but new products are not [...]

Trends Update — Synthetic Biology: JCVI’s First Synthetic Cell (or, A Goat Walked Into a Lab)

World, meet "Mycoplasma mycoides JCVI-syn1.0", 1.08-Mbps of synthetic life. Today’s issue of Science contains an article by scientists at the J. Craig Venter Institute, who have synthesized a Mycoplasma genome from scratch and transplanted it to a recipient cell. Those recipients have since reproduced using entirely the synthetic DNA. In the quest to create novel [...]

Grand Challenges Canada to Mobilize $225 Million Over 5 Years For Global Health

A new nonprofit organization called Grand Challenges Canada has been formed to deploy the Canadian government’s $225 million Development Innovation Fund. In a fabulous marriage of theory and practice, Grand Challenges will be run by Peter Singer, who is also the Director of the McLaughlin-Rotman Centre for Global Health. It also draws on an impressive [...]

Friday Science Review: May 7, 2010

Amazing!  Three Nature papers this week… Cracking the Code: The human body is much more complex than the 20,000 or so genes that are encoded in our DNA.  This multiplicity of genetic messages is enhanced by alternative gene splicing, a process where different segments of DNA exons are spliced together to create a different gene [...]

Biotech Trends Update: Non-Dilutive Financing and Fundraising by Partnering with Nonprofits

As noted in the lead up to BIO, several of the conference sessions touch on industry trends we’ve been following here on the blog. One of these was today’s session entitled “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits,” which we’ve been following as commercialization by non-profit foundations. Our coverage of that trend [...]

Battelle-BIO Data on Biotech Investment and Jobs

I just came from a breakfast meeting between Ontario’s Ministry of Research and Innovation and the Governor of Victoria, Australia. Everyone agreed on the importance of quantitative assessment of the biotech industry, and everyone agreed that finding and measuring (and communicating) success is difficult. So I was glad to be able to head straight for [...]

PubMed Central Canada Opens for Business: Free Online Access to Life Sciences Journals

The PubMed Central Canada project (noted here last July) is now open for business at http://pubmedcentralcanada.ca/ This collaboration — between the NRC’s Canada Institute for Scientific and Technical Information, the Canadian Institutes of Health Research (CIHR), and the U.S. National Library of Medicine — “aims to provide a freely accessible, Canada-based archive of biomedical and health [...]

Ontario’s New Life Sciences Commercialization Strategy Announced by Minister of Research and Innovation John Milloy

At a press conference in London today, Ontario’s Minister of Research and Innovation, John Milloy, is scheduled to announce the Province’s new $161 million Life Sciences Commercialization Strategy. The bulk of the money ($114 million) is allocated to the Global Leadership Round in Genomics & Life Sciences (GL2), though $100 million of that was announced last [...]

Biotech Trends at BIO 2010

As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions. Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on [...]

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