This week’s biotechnology news headlines include, looking to FDA for exclusivity periods and biosimilar naming guidance, CRISPR fixes blood disorder gene, experimental drug given to ebola patients, top 25 biotech companies, Sanofi planning to file dengue vaccine in first quarter, and Amgen’s blood cancer drug does well in late-stage study.
Cell Culture Dish – Ask the Expert Session
Our Next Session – Choosing the Right Genome Editing Technology for your Application and Research
Genome editing —precise, site-specific DNA modification —can now be achieved through the use of chimeric protein constructs that consist of a sequence-specific binding protein linked to a non-specific endonuclease that cleaves DNA a predictable distance from the binding site. The DNA-binding domains of transcription activator–like (TAL) effectors are known and programmable, and that knowledge can be used to create customized proteins that bind specifically to virtually any desired DNA sequence. Recently, clustered regulatory interspaced short palindromic repeats (CRISPRs), together with CRISPR-associated (Cas) endonucleases, have also been used for genomic editing. Like the chimeric TAL effector nucleases (TALENs), these RNA-guided endonuclease (RGEN) systems also have modular DNA recognition and cleavage functions—by engineering the DNA-recognition components, the endonuclease components of CRISPR/Cas systems can be targeted with high specificity to cut any genomic sequence desired.
How does genome editing fit into your research, now and in the future? Deciding which technology to use for your research may not be as easy as you think. There are many factors you should consider — what application will you be using, what cell type, desired modification, target sequence constraint’s etc.
Please reach out and ask our expert your genome editing questions on Monday!
Cell Culture Events
The Bioprocessing Summit – August 18-22, 2014 – Renaissance Waterfront Hotel – Boston, MA
Cell Line Development & Engineering – September 8-10, 2014 – Doubletree by Hilton Berkeley Marina Berkeley, CA
Cell Culture World Congress USA – September 15-16, 2014 – The Westin Copley Place – Boston, MA
Stem Cells Regenerative Medicine Conference –
World Cord Blood Congress –
“Brantly’s and Nancy Writebol’s conditions significantly improved after receiving the medication, sources say. Brantly was able to walk into Emory University Hospital in Atlanta after being evacuated to the United States last week, and Writebol is expected to arrive in Atlanta on Tuesday.”
If you like this story, please see our blog titled “Progress is Being Made Toward Using Cell Therapy for Type 1 Diabetes”
“The genome-editing method involving CRISPR and Cas9 has been called into duty for a wide variety of jobs, from cutting integrated HIV out of the human genome to turning off genes in primates. In a new development published today (August 5) in Genome Research, researchers have used CRISPR/Cas9 in human cell lines to rewrite a mutant gene that causes a blood disorder called β-thalassemia.”
If you like this story, please see our blog titled “Innovations Abound at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting”
“One week after the FDA received its first request to approve a biosimilar medicine, a handful of U.S. senators has asked the U.S. Department of Health and Human services when a formal policy will be adopted for naming these medications.”
If you like this story, please see our blog titled “Single-use Technology for Microbial Fermentation”
“The rich are getting richer when it comes to publicly traded biotechnology companies, judging by their ballooning market capitalization. It’s a product of the current Wall Street surge—some call it a bubble—that continued in the first half of 2013, with 52 companies going public and the overall market closing at record highs.”
If you like this story, please see our blog titled “Single-use Perfusion Culture Enables Continuous Bioproduction.”
“Sanofi expects to submit regulatory applications for the world’s first dengue vaccine in the first quarter of 2015 and the French drugmaker could start selling the first batches at the end of that year, CEO Chris Viehbacher said on Thursday.”
If you like this story, please see our blog titled “Highlights of the 14th World Vaccine Congress – A Cell Culture Perspective”
“FDA Releases Draft Guidance on Determining Exclusivity Periods for Biological Products,” Bloomberg BNA
“The Food and Drug Administration Aug. 4 released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act (PHS Act).”
If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-use and Sustainability”
“Amgen Inc said a late-stage study found that its blood cancer drug helped patients live significantly longer without the disease worsening, compared with standard treatment.”
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”