The Cross-Border Biotech Blog

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

Tag Archives: Health Canada

Monday Biotech Deal Review: May 16, 2011

Welcome to your Monday Biotech Deal Review for May 16, 2011. Angiotech has completed its second amended and restated plan of compromise or arrangement, cleaning up USD$250M in debt in respect of 7.75% senior subordinated notes, which are now cancelled, and has also resulted in the restructuring of $325M of existing floating rate notes through [...]

Monday Biotech Deal Review: January 31, 2011

Welcome to your Monday Biotech Deal Review for January 31, 2011.  Angiotech has voluntarily entered into CCAA proceedings and will continue its restructuring efforts there.  There was also some investment activity involving government agencies in Ontario, Quebec and Prince Edward Island.  Read on to learn more, as well as the usual assortment of biotech news [...]

Monday Biotech Deal Review: January 24, 2010

Welcome to your Monday Biotech Deal Review for January 24, 2010.  Despite a slow financing week, there were a few operational announcements as well as awards granted to Canadian biotech companies by the NIH and the UK’s Medical Research Council.  Read on to learn more. 

Biotech Trends in 2011: Biosimilars

In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been [...]

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 [...]

Health Canada’s Statistics on Patent Listings and Generics Litigation

In Canada, Under the PM(NOC) Regulations, the Minister of Health maintains a Patent Register (the analog to the U.S. Orange Book).  Health Canada collects statistics on patent listings and litigation, and Ogilvy Renault’s Life Sciences team recently put out a bulletin summarizing some of the data.  A few highlights: Out of 248 applicable generic drug [...]

Health Canada Calibrates Caffeine Consumption — Energy Drinks May Get New Labels

Two recent bulletins from Health Canada‘s caffeine directorate provide updates for the sleep-impaired.  The first update reminds us of recommended limits: 400mg/day for healthy adults.  Health Canada describes this as “about three 8oz cups of coffee.” Pay attention though, because a “medium” at Tim’s is 10oz (14oz in the U.S.) and only the rarely ordered ”short” at Starbucks [...]

Subsequent Entry Biologics (aka Biosimilars) get Final Health Canada Guidance, 6 Years of Data Exclusivity

Health Canada released the finalized version of its Guidance Document for ”Subsequent Entry Biologics” (SEBs).  The final version is mostly the same as the draft guidance released last March, and actually comes after the approval of Canada’s first SEB last April. SEBs are a class of drugs that the EU calls “biosimilars” and the U.S. calls [...]

The Long Arm of Canada’s Patented Medicine Prices Review Board (PMPRB)

In Canada, the Patented Medicine Prices Review Board (PMPRB)’s mandate is to (1) “ensure that prices charged by patentees for patented medicines sold in Canada are not excessive,” and (2) “report on pharmaceutical trends of all medicines, and on the R&D spending by pharmaceutical patentees. ” It has jurisdiction over any patented medicine “sold in any market [...]

I-131! Getchyer Rrrred Hot I-131 Here! Health Canada Approves Alternate Source for Thryoid Cancer Treatment

Draximage has been approved by Health Canada to supply I-131 from South Africa’s Safari reactor to treat Canadian thyroid cancer patients. As the Health Canada press release points out, “[p]roduction of I-131 in Canada was interrupted by the unplanned shutdown of the Chalk River National Research Universal reactor (NRU) in May 2009.” Draximage is a [...]

Swine Flu, Snake Oil

A warning from Health Canada about various products you should not buy or take that claim to “to fight or prevent H1N1 flu virus.”  Basically, there is no such thing as generic Tamiflu or Relenza approved in Canada.  Don’t get swine-dled.

Canada’s First Subsequent Entry Biologic!

Guest post from Jill Daley, part of our all-star life sciences team at Ogilvy: Today, Sandoz Canada announced that Health Canada has granted it a market authorization for Omnitrope™. This announcement marks the approval of the first subsequent entry biologic (SEB, also known as a “follow-on biologic” (FOB) in the U.S. or a “biosimilar” in the [...]

Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel. Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both. Two VA Initiatives!  In addition to the electronic [...]

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 [...]

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 [...]

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, [...]

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 [...]

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