Tag: Scrip

Food for Thought: Trade Media Update

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.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

Food for Thought: BioCentury goes TV; Mike Ward leaves

Mike Ward, long-time European Editor of BioCentury, has left the trade publication to take up a new position at Scrip, where he will head a small team that will focus on European companies, funds and regulatory issues. At present, there is no successor at BioCentury.

While the closing of the Oxford office is likely to weaken the position of BioCentury in Europe, the publication will start a policy talk show on Washington’s WUSA channel. The “BioCentury This Week” show will air every Sunday from 8:30-9:00am on Channel 9 in the Washington, DC, area and on Channel 25 Fox Boston. It will be hosted by Eric Pierce, Publisher and Steve Usdin, Senior Editor. The focus is on key issues affecting the science, business and social impact of biotechnology and in particular will feature the perspective of biotechnology policy makers. For a global audience, the show will also be streamed every Sunday from 9:00 am from the new BioCentury This Week website and will be archived thereafter for later viewing.

The first broadcast will deal with risks and benefits of drug safety measures; guests include Robert Temple, FDA’s Deputy Director for Clinical Science, Bill Vaughan, Senior Health Policy Analyst, Consumers Union, Marc Boutin, Executive Vice president and Chief Operating Officer, National Health Council, Tim Coetzee, President and Executive Director of Fast Forward, Affiliate of National MS Society, and Rep. Bart Stupak (Democrats, Mich.), Chairman of the House Energy and Commerce Committee’s subcommittee on oversight and investigations.