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February
Device Makers Said to Double FDA Fees to Get Faster Reviews
Bloomberg Business Week
Medical device makers will double the fees they pay U.S. regulators to get products reviewed over the next five years, to $595 million, in a deal designed to secure faster and more predictable evaluations, the Food and Drug Administration said today. Read More...
September
White House Boosts Translational Medicine, Drug Chip Project
AAAS.org
National Institutes of Health (NIH) Director Francis Collins's controversial plan to launch a new center for translational biomedical research got a boost today in a White House announcement on science initiatives. NIH also rolled out an early project for the planned center, promising up to $140 million over 5 years to develop a chip for predicting drug toxicity. Read More...
August
NIH finalizes financial conflict of interest rules
WashingtonPost.com
The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies. Read More...
NIH in Bethesda calls on community to help compile book of inexpensive, easy labs
Gazette.net
A first-hand experience picking up a sample of extracted DNA does not require exclusive access to the nearest genetics laboratory — a household kitchen will suffice. Read More...
July
Siblings get window into world of NIH medical procedures
Gazette.net
Kassidy Koch knows where to find fun on the Bethesda campus of the National Institutes of Health while she is waiting for her sister to finish blood work or scans. Read More...
Rule Changes Proposed for Research on Humans
New York Times
The government is proposing sweeping changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies. Read More...
FDA approves heart drug backed by Sinai doctor's research
Baltimore Business Journal
A new heart drug for which a doctor at Baltimore’s Sinai Hospital played a key role in developing has been approved for patient use by the Food and Drug Administration. Read More...
Maryland's biotech pitch: We know the Feds
Baltimore Sun
There is a new approach by Maryland economic development officials to promote the state's life sciences industry. Read More...
June
The Next Big Thing: An Obesity Initiative from the NIH
Genetic Engineering and Biotechnology News
The phrase "fat and happy" couldn't be going out of style faster. From the strangely coincident ads for weight loss and antidepressants on dating sites, to public weight-control initiatives out of virtually every source (including celebrity chefs and the President of the United States), being overweight has never been so unpopular—or popular, since fully a third of American adults are considered obese. Read More...
While Advocacy Abounds, Orphan Drug Development Success Remains Elusive
Genetic Engineering & Biotechnology News
There are some encouraging signs for rare disease research, from proposed new laws to ongoing efforts by NIH and FDA to unite researchers, patient advocates, and companies focused on developing therapies. Read More...
May
NIH stops study of niacin to prevent heart attacks
Yahoo
A drug that boosts people's good cholesterol didn't go on to prevent heart attacks or strokes, leading U.S. officials to abruptly halt a major study Thursday. Read More...
April
Appeals court overturns stem cell research ban
Associated Press
A divided federal appeals court has ruled that opponents of taxpayer-funded stem cell research are not likely to succeed in a lawsuit to stop it. Read More...
US Congress Forum Focuses On Impediments to Growth in Biotech Jobs
Pharmaceutical-Jobs.com
House Oversight and Government Reform Committee Chairman Darrell Issa recently hosted US Congress Forum in San Diego on impediments to job growth in biotech and pharmaceutical industries. Read More...
Analyst: FDA's RTF letters suggest agency is getting tougher
Fierce Biotech
Once upon a time the FDA reserved the bulk of its refuse-to-file letters for little biotech companies with little experience or know-how in the field of new drug applications. But after reviewing the FDA's letters over the past two years, Leerink Swann analyst Howard Liang found that some of the biggest pharma companies in the business have been subjected to embarrassing rejections. Read More...
FDA insider trading case a ‘nightmare'
Gazette.net
A federal chemist who learned from his agency's database that it was about to approve Vanda Pharmaceuticals' schizophrenia drug, Fanapt, made more than $1 million trading on the Rockville biotech's stock with that inside knowledge, authorities claim. Read More...
March
SBA opens 504 refinancing to more firms
Washington Business Journal
The Small Business Administration will allow more businesses to refinance their commercial real estate mortgages through its 504 loan program.
Read More...
Maryland health reform benefits touted by White House
Washington Business Journal
The federal health care reform law has provided Maryland with $69.5 million in grants and extended health care services to hundreds of thousands of state residents, according to a White House report released Monday. Read More...
February
Obama proposal would shorten exclusivity period
Fierce Biotech
The Obama Administration has unveiled its budget 2012 budget and it contains both good and bad news for drugmakers. Read More...
January
Federal Research Center Will Help Develop Medicines
New York Times
The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines. Read More...
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