This week’s headlines include, best biotech IPO regions, personalized medicine may get boost from DNA study, FDA approves Roche’s new leukemia drug, Merck’s HPV vaccine shows promise, FDA new rules to address drug shortages, and Polio in Syria.
Cell Culture Events:
Thursday November 14th Life Technologies is hosting a virtual stem cell meeting. Join speakers from around the world for a live chat session. Ask questions about their research or just listen to the questions from other researchers. If you miss a session you’re interested in, view the on demand recording. Learn more about the program including registration here.
Don’t Miss Vaccines: Formulation Development, Manufacturing and Novel Production Technologies December 4-5th 2013, Sheraton Brussels Hotel, Belgium
Informa’s annual Vaccines: Formulation Development, Manufacturing and Novel Production Technologies introduces an industry-led and scientific-driven agenda providing the latest in vaccine R&D innovation, optimising pre-clinical models, adjuvant and formulation development, novel production platforms, streamlining process development and manufacturing approaches. The 2013 conference provides the ideal mix of big pharma and small biotech to provide a varied and well represented networking opportunity.
Look for our favorite technologies to be covered next week!
Introduction to Cell Culture –December 10-13, 2013
This 4-day cell culture workshop is designed for those with no or extensive cell culture experience. Topics include an introduction to cell and tissue culture, serum containing and serum-free media, adaptation to serum-free media, cell counting and viability staining, growth curve development, growth of suspension and adherent cells, transfection technologies, cryopreservation methods, cell cloning and primary culture.
Scheduled workshops take place in Baltimore, Maryland. All of our workshops can be conducted at your location if needed. If you have questions or want more specific course content please contact our website, www.biosciconcepts.com or call us at 410-752-4224.
“U.S. regulators said on Friday they approved a new treatment from Roche Holding AG for patients with chronic lymphocytic leukemia (CLL) who have not previously been treated for one of the most common forms of blood cancer. The U.S. Food and Drug Administration said the new drug, Gazyva (obinutuzumab), works by helping certain immune system cells to attack cancer cells, and is meant to be used with a standard treatment for the disease called chlorambucil.”
If you like this story, please see our blog titled “Stir Up Your Culture – A Review of our Ask the Expert Session on Single-Use Bioreactors for Biopharmaceutical Manufacturing”
“Ludwig Cancer Research scientists report the development of a new technique that can determine whether a particular genetic sequence comes from an individual’s mother or father. Reporting their work (“Whole-genome haplotype reconstruction using proximity-ligation and shotgun sequencing”) in Nature Biotechnology, they believe their method will accelerate studies of how genes contribute to disease, improve the process of matching donors with organs, and help scientists better understand human migration patterns. “The technique will enable clinicians to better assess a person’s individual risk for disease. It is potentially transformative for personalized medicine,” says Bing Ren, Ph.D., Ludwig scientist at the University of California, San Diego School of Medicine, who led the research on the new method, called “HaploSeq.”
If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”
“Escalating its emergency battle to stop the spread of a polio revival Syria, the World Health Organization has doubled the number of children it says should be urgently vaccinated to more than 20 million throughout the Middle East, the organization’s top official in charge of eradicating the highly contagious and crippling disease said Wednesday. The official, Dr. Bruce Aylward, also said the organization’s projection of a two-month vaccination campaign — envisaged just a few weeks ago for 10 million Middle East children — would now take six to eight months, require at least 50 million doses of vaccine for repeated treatments and might require the diversion of vaccine originally intended to be used elsewhere.”
If you like this story, please see our blog titled “Vaccines an Interesting Discussion of Past, Present and Future”
“The Food and Drug Administration has forged plans to deal with the thorny medical issue of drug shortages, especially for sterile injectable drugs like those used in emergency medicine, cancer and intravenous nutrition. Under a new rule, the FDA will require companies to notify the agency of any plans to stop making drugs that are in short supply, or of any temporary manufacturing stoppages that would threaten supply. For the first time, the FDA will also apply these requirements to complex “biologic” drugs that are manufactured in microorganisms, plant cells and animal cells.”
If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development”
“An experimental Merck & Co. vaccine appeared to offer broader protection against a cancer-causing virus than the company’s Gardasil shot in clinical trials. Merck said the study results support its plan to submit the new vaccine, code-named V503, for U.S. regulatory approval by year-end, which could lead to market launch next year at the soonest. Merck expects health-care providers to eventually switch to V503 if the product receives marketing approval. Some analysts expect its annual sales could exceed $1 billion. “The case for using V503 is even stronger than the case for using Gardasil, which was already strong,” said Roger Perlmutter, head of Merck’s research-and-development unit. Dr. Perlmutter has singled out V503 as a program Merck will focus on as it overhauls its R&D unit in a bid to recover from a series of setbacks.”
If you like this story, please see our blog titled “Advances in Adherent Cell Culture Approaches Abound – Promoting Progress in Production Performance for Attachment Dependant Processes”
“If you’ve got ambitions to start and build a biotech company that may someday go public, where is the best place to make it happen? Which regional clusters provide the most fertile places where people, scientific ideas, technology, and money come together to build NASDAQ-worthy biotech companies? This is just one more way of looking at the strength and vitality of regional biotech clusters. A few weeks ago, readers may recall I ranked regional biotech clusters based on how many major league companies they have. That analysis looked at how many life sciences companies are headquartered in each region and have more than $100 million in cash and short-term investments to pursue their ideas.”
If you like this story, please see our blog titled “The Top 10 Biologic Facilities in the US”
“Aastrom Announces Results of Two Studies of Ixmyelocel-T Published in Stem Cell Research and Therapy,” 4-Traders
“Results from the first study, “Ixmyelocel-T, an Expanded Multicellular Therapy, Contains a Unique Population of M2-Like Macrophages”, show that ixmyelocel-T contains M2-like macrophages characterized by expression of multiple, well-known M2 macrophage markers, decreased secretion of pro-inflammatory cytokines after inflammatory stimuli, and efficient removal of apoptotic cells. The population of macrophages generated in ixmyelocel-T is believed to play a role in tissue repair and regeneration.”
If you like this story, please see our blog titled “3-D Bioprinting – When cells become ink”