This week’s headlines include, cell culture-based flu vaccine approved in U.S., 2012 biotech startups, FDA makes another stem cell related approval, new antibody shows promise as obesity treatment and 3-D genome organization next step in genetics.
The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using animal cell culture rather than the traditional manufacturing using chicken eggs – a speedier process that could help build stockpiles in the event of a pandemic. The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said.
If you like this story, please see our blog titled “Cell Culture Based Optiflu on List of Top Selling Flu Vaccines”
Genome sequencing projects have provided rich troves of information about stretches of DNA that regulate gene expression, as well as how different genetic sequences contribute to health and disease. But these studies miss a key element of the genome—its spatial organization—which has long been recognized as an important regulator of gene expression. Regulatory elements often lay thousands of base pairs away from their target genes, and recent technological advances are allowing scientists to begin examining how distant chromosome locations interact inside a nucleus. The creation and function of 3-D genome organization, some say, is the next frontier of genetics.
If you like this story, please see our blog titled “Is Personalized Medicine the Future? How Genetic Sequencing is Enabling New Treatments”
Luke Timmerman’s report on startup biotech companies in 2012 includes a list of more than 65 biotech startups.
If you like this story, please see our blog titled “Best Selling Biologics for 2011 – CHO Still the Top Manufacturing Choice”
Mesoblast has reached a milestone with the US FDA in regards to phase III trials of its mesencymal precursor cells (MPCs) in congestive heart failure. The regenerative medicine company said it has negotiated an agreement regarding the manufacturing process for MPCs in the congestive heart failure trial, and for phase III trials in additional indications.
The parties have also established a pathway for eventual commercial manufacturing supply of Mesoblast’s Cell Therapy products. The FDA made the decision based on comparability data from the initial set of manufacturing runs for the MPCs to be used in a phase III congestive heart failure trial, which is at the design stage.
If you like this story, please see our blog titled “Two Important Developments in Stem Cell Therapy to Treat Heart Failure”
An antibody discovered by Amgen Inc. researchers reduces weight and increases glucose tolerance in monkeys, according to a study, potentially opening up a new approach for treating obesity and diabetes in humans. The obese monkeys lost about 10 percent of their body weight during the 11-week trial, according to the study, which was paid for by Amgen and published November 28, 2012 by the journal Science Translational Medicine. The drug also lowered insulin, glucose and triglyceride levels. “This type of antibody has not been described before,” Yang Li, an author of the study and scientific director at Thousand Oaks, California-based Amgen, said in an interview. “The significance of the antibody, even just finding it, expands our view of what antibodies could potentially do.”
If you like this story, please see our blog titled “Cultureware – A New Generation of Products Step Up to the Plate”