Food for Thought: Weekly Wrap-Up


Monday, December 5, 2011

Die Welt this week reports on plans by BayerCropScience, a division of Bayer AG, to develop new, heat- and drought-resistant wheat varieties. To accomplish this goal, BayerCropScience will refrain from introducing novel genes into the wheat genome for fear of protests in Europe. However, the company is cooperating, among others, with Israel-based Evogene to also develop genetically engineered crops for other markets.

Michael Simm in Focus features the latest accomplishments of synthetic biology in which researchers control artificially introduced networks of genes in cells and tissue. As an example, scientists from the Department of Biosystems Science and Engineering (D-BSSE) in Basle, Switzerland, have inserted genes for hormone production into cells. By adding genetic control elements that can be switched on by irradiation with blue light these genes can be controlled from outside. As an example, the researchers in vitro introduced a genetic network for the production of insulin into human tissue which subsequently was micro encapsulated and transplanted to the skin of diabetic mice. After a meal, blue light is applied to switch on insulin production in order to normalize blood sugar levels. The model works well so that the researchers are thinking about clinical trials. Already, the use of light to switch on genes has led to the new scientific discipline of optogenetics which is exploring light-controlled genes and cells to treat diseases such as Parkinson’s or epilepsy. D-BSSE researchers also developed cells carrying a network of genes that is able to normalize uric acid levels in gout patients.

Food for Thought: Weekly Wrap-Up


Monday, November 28, 2011

Thomas Jüngling in Die Welt introduces auxetic materials which have the unique property of becoming broader when stretched and more tight when crushed. The effect is not depending on the material used, but on the inner structure, so that auxetic materials can be designed from metals as well as plastics. Applications span from improved bulletproof vests to seals to better sofa cushions. In medicine, auxetic materials may be used as dressing, filters, e. g. for artificial lungs, or for the delivery of drugs from plasters.

Jürgen Rees in Wirtschaftswoche introduces a technology developed by car manufacturer Volkswagen which lets an electrically powered delivery van drive autonomously and by acclamation of its driver from outside. The car is designed for courier services.

The Economist this week takes a look at personal manufacturing as the potential “next big thing”. Could be, at least in areas of the world where industrial infrastructure is poor and capital rare, the paper says. Prices for 3D printers came down from more than $100,000 to $2,500; kits may amount to $500, thanks to start-ups in the field. Add costs for the thermoplastics ($1 a pound), free software and even freely available blueprints, and personal manufacturing seems to be at the same stage as the personal computer world was when Apple introduced the Apple II.

Food for Thought: Trade Media Update


Monday, November 21, 2011

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

Food for Thought: Weekly Wrap-Up


Monday, November 21, 2011

Clemens Gleich in Die Welt reports on the development of super batteries able to power a smart phone or notebook for days without re-charging. While some researchers try to improve conventional lithium-ion batteries by modifying the carbon-based anode with silicon, others design lithium-oxygen or fluorine-oxygen batteries. Main challenges are safety, prevention of swelling and maintaining a high capacity.

Britta Verlinden in Die Zeit reports on the discovery that dimethyl fumarate, a standard drug used for the treatment of psoriasis since 1994, may also be used as a pill to treat multiple sclerosis. Preliminary results of a Phase III trial demonstrate its ability to significantly reduce the number of attacks. The drug candidate codenamed BG-12 is being developed by Biogen Idec. The paper raises the concern that BG-12 may be sold as MS medication at €15,000 a year – while based on the price of the same compound for psoriasis, costs would amount to €4,400 per year, which already “is clearly more costly than what might be expected based on the cheap basic material”.

Food for Thought: Boehringer Ingelheim Puts Pradaxa Cards on the Table


Thursday, November 17, 2011

When German pharma company Boehringer Ingelheim on November 12 said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa, the figures were taken up by many media as evidence that Pradaxa dabigatran, which was launched in Europe in September this year, was a dangerous drug.

In a courageous move, Boehringer Ingelheim yesterday released detailed data from the drug safety database, data that are usually submitted to regulatory agencies only.

Now that the figures are out, several media have taken up the issue again to put it into perspective. Hartmut Wewetzer in Der Tagesspiegel writes that every drug inhibiting blood coagulation poses the risk of bleeding. Wewetzer cites Christoph Bode, a heart specialist from University Clinic Freiburg, as saying that Pradaxa is lowering the risk of fatal bleeding in the brain to 25%, which is a superior value compared to vitamin K antagonists such as Marcumar and Warfarin, the therapeutic standard of previous decades.