This week’s headlines include, Bayer invests in hemophilia drugs, GSK’s asthma candidate succeeds in late-stage, low rate protein synthesis critical to stem cell function, top biopharma clusters, Sanofi and Regeneron to assess cholesterol drug cognitive risks, and FDA fast tracks Ebola drug.
Cell Culture Events
March 24-27, 2014 – San Diego, CA
Event Website: www.IBCLifeSciences.com/BDPWeek
BDP Week provides you the most in-depth coverage of bioprocessing methods in the field, to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline.
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March 24-26, 2014 –Washington DC
Now in its 14th year, the World Vaccine Congress US 2014 promises to address the latest challenges being faced by the vaccine sector and give you access to the latest science in this fast-evolving industry.
Join us on March 24-26 in Washington D.C. to participate in 3 jam-packed days covering new insights into the regulatory landscape, the latest approaches to vaccines, the challenges and opportunities in emerging markets, innovative technologies and more.
March 18-20, 2014 – New York City
INTERPHEX (International Pharmaceutical Expo) is THE single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms for life-enhancing drugs.
April 2-3, 2014 – Clarion Congress Hotel, Prague, Czech Republic
The countdown to BioProcess International Europe SUMMIT 2014 begins!
Join us to reflect on the critical challenges facing the production, analysis and formulation of biologics.
This meeting congregates top industry speakers in 5 conference streams, in 1 unique venue. Don’t miss this opportunity to challenge conventional thinking and prepare for the next wave of products, processes and technologies shaping the future of your industry, your company and ultimately, your career.
Mark your diary to join us in April 2014 in Prague !
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“GlaxoSmithKline Plc said its non-inhaled treatment for a type of severe asthma met the main goals in two late-stage studies. In one study, the treatment, mepolizumab, showed statistically significant reduction in the frequency of exacerbations in patients of severe eosinophilic asthma compared with a placebo, GSK said on Wednesday.The second study showed that patients on mepolizumab achieved greater reduction in their oral corticosteroid dose compared with those on placebo, while maintaining asthma control”
If you like this story, please see our blog titled “Troubleshooting Media Development for Bioprocessing”
“GEN’s top 10 U.S. biopharma clusters offer, to borrow the oft-used phrase, something old, something new, something borrowed, and something blue. Old is the trio of regions atop the list—the San Francisco Bay Area, Boston/Cambridge, MA, and San Diego. Those regions have usually headed any of a number of top-biotech-region lists published in recent years. New could be New York, which placed at the middle of the list; or new innovation, as in patents awarded, one of this list’s five key criteria. The other four are NIH grant funding, venture capital funding, total lab space in the region, and number of jobs. Borrowed is how investors hope startups view the millions they receive in venture capital—not because startups cannot lose money or go bust (they do often), but because those investors expect repayment, with substantial returns, from the awards.”
If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“Tekmira Pharmaceuticals Corp. said the U.S. Food and Drug Administration has granted fast-track status for the development of its anti-Ebola viral treatment, TKM-Ebola. Shares jumped 9% to $27.16 after hours. The treatment is being developed under a $140 million contract with the U.S. Defense Department’s Medical Management Office. In January, the company announced that the first subject had been dosed in a Phase I clinical trial evaluating the safety of the treatment, and Tekmira on Wednesday said it remains on track to have data from this trial available in the second half of this year.”
If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-Use and Sustainability”
“Bayer said it plans to spend more than 500 million euros ($694 million) to set up haemophilia drug production sites in Germany, one of the largest investments to date by the German company’s healthcare unit. Bayer’s established haemophilia A therapy product Kogenate, with 1.2 billion euros in sales last year, has been exclusively produced by a Bayer facility in Berkeley, California. It has two more drug candidates against the type A of the hereditary bleeding disorder in the third and last phase of testing on humans that is required for regulatory approval.”
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”
“The U.S. Food and Drug Administration has asked Regeneron and Sanofi to assess potential neurocognitive side effects of their experimental cholesterol drug, Sanofi said in its annual report on Friday. The regulatory filing sent shares of Regeneron down 6 percent in Nasdaq trading. U.S.-listed shares of France-based Sanofi were down 1 percent.Their drug, alirocumab, is part of a new class known as PCSK9 inhibitors designed to block a protein that maintains “bad” LDL cholesterol in the bloodstream.
If you like this story, please see our blog titled “Choosing a Cell Culture Media Development Strategy for Biopharmaceutical Production”
“Genetics will be a cheap and critical part of daily life, 23andme co-founder Anne Wojcicki has told the SXSW festival, claiming that genetics should be used for preventative medicine to bring down the cost of healthcare. Sketching out the scale of an industry worth more than $3 trillion, Wojcicki said that working on Wall Street, she had seen how the industry has a profit incentive for illness, making money from everything from flu to diabetes and obesity.“Obesity is awesome from a Wall Street perspective,” she said. “It’s not just one disease – there are all sorts of related diseases to profit from.”
If you like this story, please see our blog titled “2013 FDA New Drug Approvals”
“For the first time, protein synthesis has been studied in somatic stem cells. It turns out that in hematopoietic stem cells (HSCs), low rates of protein synthesis may be essential for maintaining metabolic homeostasis. This result, the work of scientists centered at UT Southwestern Medical Center, could lead to insights about all kinds of cells, not just stem cells. That is, rates of protein synthesis could be determined for various kinds of cells, and comparisons of these rates could serve as indicators of cellular function and health, even longevity. According to Dr. Sean Morrison, director of the Children’s Research Institute, Professor of Pediatrics, and the Mary McDermott Cook Chair in Pediatric Genetics at UT Southwestern Medical Center, “This finding not only tells us something new about stem cell regulation, but opens up the ability to study differences in protein synthesis between many kinds of cells in the body. We believe there is an undiscovered world of biology that allows different kinds of cells to synthesize protein at different rates and in different ways, and that those differences are important for cellular survival.”
If you like this story, please see our blog titled “Learning More About Your Cells by Employing Flow Cytometry and Cell Imaging Platforms – Troubleshooting Challenges