This week’s headlines include, how the sequester will impact healthcare research, best selling drugs of 2012, challenges for biosimilars, stem cell news, and EMA opens up debate on pig products in vaccines.
“As the Obama administration begins to implement $85 billion in cuts to federal spending this year, no part of the budget other than defense will take a bigger hit than healthcare. And the so-called sequester appears likely to have a disproportionate effect on areas of the health system already hobbled by years of retrenchment or underfunding, including public health and medical research.”
If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”
“The European Medicines Agency (EMA) has opened a debate on the safe use of animal-derived products in vaccines. Publication of the draft guidelines comes three years after the discovery of pig-virus DNA in vaccines from GlaxoSmithKline and Merck prompted a regulatory rethink. In April 2010 the use of new, more sensitive tests revealed the presence of contaminants in GSK and Merck rotavirus vaccines. The problem stemmed from the use of pig-derived products and, in the case of GSK, dated back to clinical testing of the vaccine. Since the contamination, EMA has worked to tighten quality controls and has now opened up draft guidelines for consultation.
If you like this story, please see our blog titled “Severe Flu Season Puts Spotlight on New Vaccine Technologies and Existing Challenges”
“BioLamina signed a research and development agreement with Roche to jointly develop new cell culture systems for various applications, including Stem Cell Research. The collaboration will focus on assessing laminin-based in vitro cell culture matrices that offer physiological microenvironments for living cells. Under the terms of the agreement Roche will provide R&D funding and scientific expertise to BioLamina. Laminins are proteins located in the extracellular matrix giving the stability essential for cell growth and behavior. They are the only protein group in this environment that have a tissue-specific distribution, including expression of specific laminins during embryonic development, according to BioLamina. This makes them a very interesting target for new biologically relevant cell culturing techniques, according to Ruedi Stoffel, head of biochemical reagents and custom biotech at Roche.
If you like this story, please see our blog titled “Identifying Options for Stem Cell Based Therapy Scale Up”
“Biomedical research and innovation are crucial to improving America’s health, global competitiveness, and economic growth, as both President Obama and House Majority Leader Cantor have stressed in recent weeks. In the wake of the sequester, and as the President and Congress move ahead with budget negotiations, now is the time for both parties to translate into action their bipartisan commitment to our nation’s science investment by restoring the budgets of the National Institutes of Health (NIH) and other science agencies that support basic biomedical research in universities and medical schools in all 50 states – an area of federal spending that is highly productive and a critical investment. History shows that investment in basic research pays. Research supported by NIH has been key to reducing mortality from heart disease and stroke by more than 60 percent since 1970, with an economic return estimated at $2.5 trillion per year. HIV/AIDS, which once threatened to overrun our hospital systems, is manageable today without hospitalization thanks to breakthroughs enabled by NIH, with total savings of $1.4 trillion to date.”
If you like this story, please see our blog titled “Best Practices in Cell Therapy Manufacturing”
“Life Technologies signed a research and license agreement with Harvard University under which the firm has acquired exclusive rights to develop a panel of characterization assays designed to rapidly evaluate human pluripotent stem (hPS) cells for their utility in a variety of discovery and translational research applications. The panel will be offered on the company’s semiconductor sequencing and PCR-based genetic analysis platforms. Life Tech expects this will help overcome hurdles that impede stem cell technology from moving into the clinic. Standardizing the way researchers characterize induced pluripotent stem (iPS) cells will allow them to quickly identify the most promising cell lines and avoid wasting time and resources on cells that do not possess the appropriate characteristics, Life Tech says.
If you like this story, please see our blog titled “The Value of Cord Blood Stem Cells in Healthcare and Research”
“Without a growing economy that creates more high-paying jobs, both President Barack Obama and congressional Republicans face the unpalatable prospect of much higher taxes or reductions to popular programs (or both). Growth is the best way to cut this Gordian knot. One place to start is by lowering unnecessary barriers facing innovative U.S. companies that are trying to bring new products to market, particularly in the biopharmaceutical sector. Less sensitive to the business cycle, with jobs that pay about double the average private-sector salary, biopharma is a leading U.S. exporter.”
If you like this story, please see our blog titled “The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High”