- FDA to fast-track Dx tests as MERS is declared public health threat
The U.S. government this week declared the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) a public health emergency and national security threat, a declaration that empowers the FDA to fast-track diagnostic tests and other tools used to identify and prevent infections in U.S. citizens abroad. Similar designations were made for H1N1 swine flu in 2009 and for H7N9 bird flu this year. MERS has infected 54 people so far, and 30 of them have died. The Hill/Healthwatch blog (6/4)        | Stop banking and start building with GE Capital, Healthcare Financial Services
At GE Capital, we're not just bankers, we're builders. Supporting the growth of life science companies, large and small, as a reliable source of financing is our mission at GE Capital, Healthcare Financial Services. With in-depth industry experience and expertise, our dedicated Life Science Finance team has provided over $1.7 billion in financing over the past 10 years. Stop just banking. And start building. Learn more. | |
| Health Care & Policy |  |  | | - GPhA: FDA should revise draft guidelines on biosimilar meetings
Some revisions are needed for the draft guidance on formal meetings between the FDA and sponsors of biosimilar products, the Generic Pharmaceutical Association said. "Formal Meetings Between FDA and Biological Product Sponsors or Applicants" must be clarified to guarantee a full understanding of the requirements and expectations of the FDA, the group said. The FDA should also explain if a request for a first biosimilar advisory meeting can be rejected, and provide guidance on such situations, the group said. Bloomberg BNA (free content)/Pharmaceutical Law & Industry Report (6/5) - FDA expands use of Revlimid to include mantle cell lymphoma
Celgene obtained the FDA's approval to market Revlimid, or lenalidomide, in mantle cell lymphoma patients whose condition has relapsed or progressed after receiving two previous treatment regimens, one of which should include Takeda Pharmaceutical's Velcade, or bortezomib. The approval, based on the results of the MCL-001 midstage trial, makes Revlimid the first oral drug for MCL. Reuters (6/5), RTT News (6/5) - Leukemia study finds mutation that limits blood stem cells
Researchers have discovered that a single mutation in the leukemia-associated gene JAK2 can reduce the ability of blood stem cells to replicate. The mutation is commonly present in patients with myeloproliferative neoplasms. The team plans to further study the effect of additional mutations on cells, which could provide clues on how leukemia develops. The findings were reported in PLOS Biology. Genetic Engineering & Biotechnology News (6/4) | Company & Financial News | | | | | Industry Deals | | | | - Cellular Dynamics gains rights to nuclease technology patents
Cellular Dynamics International secured licensing rights to patents covering GeneArt Precision TALs from Life Technologies and the CompoZr zinc finger nuclease platform from Sigma-Aldrich. CDI plans to use the patents to develop disease models and controls. The "combination of these nuclease technologies with CDI's iPSC-derived cells creates a new, powerful tool to better understand and target human disease," Cellular Dynamics CEO Bob Palay said. GenomeWeb Daily News (free registration) (6/5) | Food & Agriculture | | | | - Ore. wheat mingling may be an act of sabotage, Monsanto says
The discovery of a long-shelved biotech wheat in an Oregon field is an isolated occurrence that could be the result of an "accidental or purposeful" act, Monsanto said. The firm tested 30,000 samples of commercial wheat seeds in Oregon and Washington state, and found no presence of its herbicide-resistant biotech trait. Monsanto said it is possible that the incident was an act of sabotage, but other possibilities can't be ruled out. "We know that the circumstances are highly unusual. We're going to continue to do the research until we get to the answer," said Monsanto Chief Technology Officer Robb Fraley. Reuters (6/5), USA Today/The Associated Press (6/5) | Industrial & Environmental | | | | - BIO, other groups knock RFS hearing as one-sided
Brent Erickson, executive vice president of BIO's Industrial and Environmental Section, questioned a House committee's decision not to invite biofuel industry representatives during a hearing on the Renewable Fuel Standard. The hearing heavily skewed in favor of the oil industry, resulting in a biased impression of the policy, according to biofuel supporters. "The first commercial cellulosic biofuel refineries are starting up, and more are scheduled to come online over the next few years," Erickson said. "Moving the goalposts on the industry by undermining the RFS will unnecessarily halt their progress and postpone achieving the nation's goals of energy security and a healthier economy and environment." EthanolProducer.com (6/5) | News from BIO | | | | - Industrial biotechnology with a French twist!
Over 1,300 leaders in biofuels, biobased products and renewable chemicals will be in Montreal June 16-19 for the 10th Annual BIO World Congress on Industrial Biotechnology. Join the impressive list of attendees for great food, excellent wine, and a can't miss program which will feature plenary sessions, breakout tracks, workshops, investor sessions, poster presentations, an exhibit hall, networking receptions, and business partnering. BIO is excited to bring this conference to Montreal, highlighting the industry's growth and the importance for generating green jobs and producing greener products and cleaner processes, all aimed at building a biobased economy. Learn more.
| SmartQuote | | | |  | Being rich is having money; being wealthy is having time."
--Margaret Bonanno,
American writer  |
| | This SmartBrief was created for jmabs1@gmail.com
| | | Read more at SmartBrief.com | | A powerful website for SmartBrief readers including: | | | | | | | | | | Recent BIO SmartBrief Issues: - Wednesday, June 05, 2013
- Tuesday, June 04, 2013
- Monday, June 03, 2013
- Friday, May 31, 2013
- Thursday, May 30, 2013
| | | Lead Editor: Tom Parks
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004 | | | | | | © 1999-2013 SmartBrief, Inc.® Legal Information |
|
No comments:
Post a Comment