Most Clicked BIO SmartBrief Stories
1. FDA releases draft guidance for biosimilars
BIO SmartBrief | Feb 10, 2012
The FDA issued draft guidance for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs, and in some cases trials may not be required. BIO President and CEO Jim Greenwood welcomed the release. "We look forward to reviewing the drafts in detail to ensure that they comply with our key principles," he said. Bloomberg Businessweek (02/12) Pharma Letter (U.K.), The (subscription required) (02/10) Reuters (02/09)
2. Analysis: Drug R&D costs high compared to returns from products
BIO SmartBrief | Feb 15, 2012
When spending on candidates that don't make it to market is taken into account, the average cost to develop a new drug ranges from $4 billion to $11 billion, with the costs of manufacturing and clinical testing adding to $1 billion for some approvals, writes Matthew Herper. "It really does cost billions of dollars to invent new medicines for heart disease, cancer, or diabetes," Herper writes. "We can all only hope that new technologies and a better understanding of biology will turn things around." Forbes (02/10)
3. Execs, regulators, watchdogs, pioneers on biotech most-influential list
BIO SmartBrief | Feb 09, 2012
BIO President and CEO Jim Greenwood, FDA Commissioner Dr. Margaret Hamburg and GlaxoSmithKline CEO Andrew Witty are among the 25 most influential people in biotechnology, according to this Fierce Biotech report. Also making the list are synthetic biology pioneer J. Craig Venter and executives with the world's biggest pharmaceutical companies. FierceBiotech (02/07)
4. Planned pharma layoffs nearly doubled in January
BIO SmartBrief | Feb 13, 2012
The drug sector planned to eliminate 4,071 positions in January, compared with 2,090 in the same month last year, according to Challenger Gray & Christmas. A few companies accounted for most of the jobs. Looking ahead, this month is expected to bring the announcements of at least 2,000 pharma job cuts. Genetic Engineering & Biotechnology News (02/10)
5. Alexion finalizes acquisition of Enobia for $1.1 billion
BIO SmartBrief | Feb 09, 2012
Alexion Pharmaceuticals completed its $1.1 billion takeover of Canada's Enobia Pharma. The deal gives Alexion full rights to Enobia's asfotase alfa, which is under clinical trials to treat hypophosphatasia. Hartford Courant (Conn.), The (02/08)
6. FDA's proposed $4.5 billion budget heavily depends on industry fees
BIO SmartBrief | Feb 14, 2012
The FDA asked for a $4.5 billion budget for fiscal 2013, up 17%, or $654 million, from this year. Industry user fees, including proposed fees for generics and biosimilars, would account for 45% of the budget and would fund 98% of the increase in spending. DOTMed.com (02/13) Reuters (02/13)
7. Researchers develop gel that can heal bone fractures
BIO SmartBrief | Feb 10, 2012
U.S. researchers have created a gel with fracture-healing properties using a protein developed from adult stem cells. The gel, dubbed "fracture putty," fully healed rats with fractures after two weeks. The researchers said tests on larger animals are going well. Daily Mail (London), The (02/08)
8. Texas board sets tentative rules for adult stem cells
BIO SmartBrief | Feb 13, 2012
The Texas Medical Board approved a provisional policy that would allow doctors in the state to provide stem cell therapy if they get permission from an independent review committee that evaluates trials for patient safety. The policy will be reviewed for final approval April 13. Houston Chronicle (02/10)
9. Four rules for a successful grant proposal
BIO SmartBrief | Feb 13, 2012
Cynthia Sollod, director of science and technology development at N.C. Biotechnology Center, lays out four rules for creating a successful research grant proposal. A strong research proposal should be written in clear, concise language and must support the objective of the granting organization. A grant proposal should explain both the main and contingency plans to execute a strong, innovate idea, and it should include details about how the plan will be executed. WRALTechWire.com (Raleigh, N.C.) (02/10)
10. HDL, triglyceride genetics play a role in type 2 diabetes
BIO SmartBrief | Feb 14, 2012
A study in Diabetes revealed that the risk of type 2 diabetes grew by 3% for every point in a high-density lipoprotein genotype score, while a one-point increase in triglyceride genotype score was associated with a 2% increased risk of developing the disease. The study was based on data from the Nurses' Health Study and the Health Professionals Follow-up Study. PhysiciansBriefing.com (02/13)
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