Galantamine and transdermal rivastigmine plaster can delay loss of cognitive function in Alzheimer’s disease (AD) patients, Germany’s Institute for Quality and Efficacy in Health Care (IQWiG) said in a preliminary report published on its website. In 2007, IQWiG had issued a negative report on the benefit of donezepil, galantamine and rivastigmine, however in 2009 the institute initiated an update, adding additional published and unpublished studies for the appraisal of galantamine and including the rivastigmine plaster which entered the German market in 2007.
IQWiG now states that galantamine at higher doses has a positive effect on cogitation and retentiveness of female patients with mild and moderate AD. However, it added that there was no evidence of improvement of daily routine abilities or psychopathological symptoms such as unrest and depression in both male and female patients. In addition, IQWiG notes that patients often dropped out of the study because of side effects such as nausea, vomitus or diarrhea. It also states that it did not find evidence supporting a galantamine treatment for more than 12 months.
For the rivastigmine plaster, IQWiG said it found hints that the 10 square centimeter plaster improves cognition of patients under 75 years of age; however it states that the data were not resilient enough to support an assessment as “proof of efficacy.”
IQWiG said that both manufacturers, the pharma companies Janssen-Cilag and Novartis, provided all study data requested by IQWiG, including unpublished data comprising 48% of study patients. Juergen Windeler, head of IQWiG said in a statement that this was further underlining the necessity to introduce mandatory publication of clinical study data.
Andreas Sentker in Die ZEIT takes up the issue of rising eco-terrorism in Germany directed against field trials of genetically modified plants. These plants are an easy target as trial sites have to be disclosed to the public in registers following legislation initiated by the former red-green coalition in Germany. While in the past years opponents of genetically modified plants only targeted the plants they dub as “Gen-Dreck”, violence is now also directed against security firms and guards watching the fields. Last week, a masked gang assaulted security guards, looted their mobile phones and destroyed different plants of research projects from the University of Rostock. The plants were carrying genes for the production of biopolymers and for a vaccine against viral diseases.
In Süddeutsche Zeitung (SZ), Hanno Charisius introduces efforts to create artificial leaves mimicking photosynthesis to create hydrogen which can be used as fuel or energy source. Daniel Nocera from the Massachusetts Institute of Technology (MIT) is just using the principle: water molecules are split using electrical current produced by solar cells – an ages-old principle. Noceras new twist, however, is the use of a mix of cobalt and phosphate as a catalyst. The mix is accumulating at the electrodes, but after a while it is crumbling and thereby regenerating. The reaction is not the most effective one, but prototypes are already running for months without efficiency drop. First machines will now be installed in India for tests in realistic conditions; the goal is to meet the daily power demand of an Indian family by using just 4 liters of water and sunlight. Nocera is now trying to combine his catalyst with solar cells to a single device.
Katrin Blawat, also in SZ, in a somewhat pessimistic article deals with the many failures to develop a drug to combat Alzheimer’s disease. Given that there are neither cures nor effective therapies to prevent or delay the onset of AD, she cautions against tests for early diagnosis.
Another negative outlook is given by Werner Bartens in the same paper. Bartens deals with personalized medicine, calling the concept a “set phrase” invented to disguise that personalized medicine is a mere “PR strategy by the pharma industry and stakeholders from academia” invented to lay a smoke screen on the failure to develop new blockbuster drugs. For Bartens, the “niche buster concept” is “science fiction” allowing the pharma industry to obtain approval without any proof of patient benefit. As an example, Bartens interestingly mentions the introduction of personalized cancer drugs of which only a fraction of the patients is benefitting.
In contrast, Ronald D. Gerste in Neue Zürcher Zeitung (NZZ) writes about how cancer patients have profited from targeted therapies, e.g. in terms of decreasing cancer mortality and improved survival. Gerste features a trial by the MD Anderson Center in Houston/Texas in which 460 cancer patients underwent detailed molecular genetic analysis. Subsequently, they were treated by a matching therapy addressing the most promising molecular mechanism. Without applying any experimental drugs, this procedure increased survival from 9 to 13.4 months on average.
Also in NZZ, Stefan Betschon makes the case for better science communication, introducing an article by Dirk Helbing and Stefano Bialetti on “how to create an innovation accelerator“. They propose to improve the academic publication system by publishing articles ahead of peer review finalization and call for review by crowd sourcing. Rejected publications should also be made public, alongside with comments.
The Economist this week casts doubt on whether the goal to eradicate polio by the end of 2012 can be met. The disease is still endemic in four countries (Afghanistan, Pakistan, India and Nigeria), however re-emerged in African and Asian countries in recent years. Reasons are political (war, refugees, etc.), socioeconomic (poor sanitation) and medical (vaccines needs cold chain, virus can hide in asymptomatic carriers) factors.
Another article in The Economist deals with epigenetics findings by a German research group from the University of Konstanz. The team found that stress during pregnancy (abuse, violence, famine, death of a relative etc.) can lead to a change in the DNA methylation patterns of the unborn child, e.g. of the gene coding for glucocorticoid receptors which relay signals from stress hormones in the blood to cells of the brain regions controlling behavior. The findings may explain why children of stressed mothers show higher-than-normal rates of psychological and behavioral disorders and may lead to insights about how and when interventions are possible and promising.
Andrew Pollack in the New York Times features discussions on changing the rules for research in human subjects. The US government claims that changes are needed in the light of genomics studies using patients’ DNA samples, the use of the Internet and a growing reliance on studies that take place at many sites at once. Among the proposed changes are adding informed consent rules to donors of blood, DNA or tissue samples and allowing a single institutional review board for multiple-site clinical studies.
And finally, for all of us struggling daily with the touchscreen keyboards of our iPads and iPhones, IBM comes with a solution: a keyboard that morphs to fit an individual’s finger anatomy and typing style. Paul Marks in Wired dug out an IBM patent describing keyboards in which buttons are automatically resized, reshaped and repositioned according to the users typing style.
In the US, venture capital funding in biotechnology companies jumped 46 percent in the second quarter, according to a report by the National Venture Capital Association and PricewaterhouseCoopers LLC.
Biotechnology companies attracted $1.24 billion in 116 deals (about $847 million in 97 first-quarter investments), adding up to about $2.1 billion and 213 deals in the first half of this year. Funding for medical device and equipment makers gained 26 percent to $841 million in 90 deals in the second quarter .
At least 33 U.S. biotechnology companies were acquired during the first half of the year, for a total of $26.7 billion.
Scil Technology GmbH, a biopharmaceutical company with core expertise in protein drug development, formulation and analytics, today announced the establishment of an independent service unit named formycon. formycon offers services for external customers focusing on formulation development, drug product manufacturing and process development, as well as quality control and analytics. Scil Technology’s long-standing track record in protein development enables formycon to support its customers with key activities such as protein characterization, preformulation, formulation development and drug product production as well as analytics under GMP and non-GMP conditions (including analytical method development).
In addition to liquid and freeze dried formulations, formycon also offers liposomal and specialty formulations, e.g. for topical and local administration – an area which distinguishes formycon from most other service providers worldwide. Therefore, formycon´s core strengths lie in the combination of a broad range of formulation types with comprehensive knowledge of regulatory processes and excellent analytics according to GMP standards and the requirements outlined by the ICH and pharmacopoeias.
formycon is operating on a fee for service basis and employs a staff of 20. The unit is licensed and GMP-certified as an analytical laboratory.
