The Cross-Border Biotech Blog

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

Category Archives: Wednesday Brain Dump

Wednesday Brain Dump: Plant Matter Edition

Some stories from the world of plant biotech:

P.S.  After today, the Wednesday Brain Dump will be dropping the “Wednesday” and becoming an occasional feature.

 

Bookmark and Share

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 medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

Bookmark and Share

Wednesday Brain Dump: Things that Might Surprise You Edition

Things that surprised me this week:

Bookmark and Share

Wednesday Brain Dump: Deal-O-Rama Edition

There’s still plenty of deal activity in the pharma and biotech sector this week, even outside Canada, so here’s a roundup of what’s done, what’s pending and what’s in the rumor mill:

Read more of this post

Wednesday Brain Dump: Around the World Edition

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…

Bookmark and Share

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:

Bookmark and Share

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.

Bookmark and Share

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 the overall B.C. infant vaccine schedule, and
    • With the discovery of a constant region of flu virus protein hemagglutinin, a universal flu vaccine may be possible (no more yearly shots);
  • The Naval Surface Warfare Center in White Oak, a suburb of Washington, where the FDA is spending $1.15 billion to consolidate its offices and labs and to anchor a new biotech hub;
  • Pine Island, near Rochester, Minnesota, which could soon be the home to a new biotech research, development and manufacturing park with the help of up to $900 million in funding reportedly pledged by Steve Burrill.  Funding announcements also from Maryland and Pittsburgh;
  • Sustainable agriculture, when the White House announced its nominee for second-in-command at USDA: Kathleen Merrigan of Tufts University, who had been a top choice of the Cornucopia Institute to run USDA’s National Organic Program;
  • The National Science Foundation, from the stimulus (a $3 billion boost) and the budget (a 6.7% increase, to $6.49 billion);
  • Multiple Sclerosis, with Merck, Novartis, Teva, Biogen Idec and Sanofi Aventis all planning to release new oral therapeutics between now and 2012;
  • Conflict of interest disclosure, with a new editorial in PLoS Medicine;
  • Deterrence, with the arrest of four animal-rights extremists;
  • Organ failure biomarkers,
    • with the discovery of liver toxicity-associated MicroRNAs, and
    • with the injection by Pfizer Canada of $1 million to the PROOF Centre to fund research into vital organ failure biomarkers; and
  • Aliens.

A kick in the teeth for:

Bookmark and Share

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…

And on the topic of vaccines, the U.S. vaccine court issued three different rulings on a group of vaccine-autism claims, and didn’t mince words.  The three Special Masters found the claims “speculative and unpersuasive,” “overwhelmingly contrary” to the evidence and relying on “scientifically flawed or unreliable articles”, respectively.

Last but not least, a few viruses turned up in new and interesting places:

Bookmark and Share

Wednesday Brain Dump: February 11, 2009

Deep Appreciation:for Phillip Terrence Ragon, founder and sole proprietor of database-software provider InterSystems who donated $100 million to establish a research institute that focuses on expediting the development of an AIDS vaccine, and to Pfizer Canada which contributed a further $2 million to British Columbia’s Center for Drug Research and Development (CDRD); and The State of Georgia is contemplating a $180 million bioscience research park.

Social Agitation: French scientists decided their street protests were their best approach to halting the government’s science and higher education reforms and rejected mediation.

Better Cogitation:Brain-Derived Neurotrophic Factor (BDNF) shows neuroprotective effects in animal models of Alzheimers’, but it won’t stop cries of ‘brain drain’ following Canada’s 2009 Budget.

Free Publication: ScienceInsider reports that Rep. Conyers’ (D-MI) bill that would eliminate free full-text publication of NIH-funded research is back on the table this session.

Self Regulation:More Pharma companies are implementing voluntary disclosure of physician payments (under threat of legislation); and some researchers are taking steps to prevent disclosures of potentially harmful research (under threat of annihilation).

Reconsideration: Researchers at Emory decided that flu pandemic deaths in 1918 may have been primarily from bacterial superinfections rather than the virus itself; Icahn decided to nominate another slate of Biogen-Idec directors; Everybody decided to take another look at their luciferase screening assay controls; and the Ontario Health Insurance Plan (OHIP) decided to take another look at payment for PSA testing for prostate cancer detection.

Bookmark and Share

Wednesday Brain Dump: February 4, 2009

Some good news on the gene therapy front in adenosine deaminase-deficient SCID patients and in rheumatoid arthritis.

But mostly bad news on the job front at GSK, AstraZenecaAbbott,  GenVecPatheon, and others.

Other good news on the approvals front for Parusgel (despite process concerns), KapidexLamictalGelnique and Taxus Liberte.

Really small news: Nanomaterials may be heading for increased regulation in Canada, with a mandatory reporting program reportedly pending and a new guide from IRSST in Quebec (pdf) (although the IRSST guide doesn’t mention bio-materials).

Just NICE news: Comparative Effectiveness may be headed for some changes in the UK, where NICE is working on a review.

Positively Biblical news: The lion lies down with the lamb (or something equally unlikely)

Bookmark and Share

Wendesday Brain Dump: January 28

Things that caught my eye this week:

The FDA made Geron very happy; Sarkozy made French scientists very unhappy.

Here at home, some regulatory milestones for Oncolytics, Welichem and Pfizer Canada.

Europe’s R&D intensity (spending as a percentage of GDP) was stagnant overall from 2000 to 2006, but at least a few detractors are out of commission.

And last, since we don’t want to dwell on the negative, some advice from PwC on transfer pricing and other more general approaches to weathering the downturn.

Bookmark and Share

Follow

Get every new post delivered to your Inbox.

Join 130 other followers