December

Would complete disclosure cure the NDA-rejection rash?
FierceBiotech
John Jenkins, the head of the FDA's Office of New Drugs, has the perfect cure for a chronic rash of poorly conceived new drug applications: Sunshine. Jenkins suggests that the agency's complete response letters should be made public when a new therapy doesn't make the cut at the FDA. Read More...

Feds' anthrax shift triggers sharp drop in developers' shares
FierceBiotech
The U.S. Department of Health and Human Services has decided to drop a request for proposals for a next-gen recombinant protective antigen anthrax vaccine, saying the agency doesn't believe that developers can deliver one that could win FDA approval within eight years. Read More...

US researchers get new embryonic stem cell lines
Yahoo! News
US authorities Wednesday approved 13 new lines of human embryonic stem cells for scientific research in the first such move since the Obama administration lifted a ban on their use. Read More...

November

Eric Green Tapped to Lead NHGRI
GenomeWeb
Eric Green will take over the top post at the National Human Genome Research Institute, filling the role formerly held by National Institutes of Health Director Francis Collins and currently by Acting Director Alan Guttmacher. Read More...

October

Judge dismisses lawsuit challenging stem cell rule
Yahoo! News
A judge on Tuesday dismissed a Christian adoption agency's challenge to Obama administration regulations expanding stem cell research.
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September

NIH Announces 115 Awards to Encourage High-Risk Research and Innovation
Press Release
The National Institutes of Health (NIH) announced today that it is awarding $348 million to encourage investigators to explore bold ideas that have the potential to catapult fields forward and speed the translation of research into improved health. Read More...

Where cancer progress is rare, one man says no
New York Times                                                                                                         Politicians and researchers have predicted for nearly four decades that a cure for cancer is near, but cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life. For this collective failure, the man atop the nation’s regulatory agency for new cancer drugs increasingly — and supporters say unfairly — gets the blame: Dr. Richard Pazdur.  Read More...

U.S. approves H1N1 vaccine, says enough for everyone
Reuters                                                                                                                     U.S. health officials have approved vaccines from four drugmakers to help prevent the H1N1 swine flu, ensuring there will be enough to inoculate Americans who want the protection, U.S. Health Secretary Kathleen Sebelius told lawmakers on Tuesday.  Read More...

NIH to Grant $6M for Pioneer Awards in FY 2010
GenomeWeb
The National Institutes of Health plans to award a total of $6 million under its Directors Pioneer Award program in fiscal 2010. Read More...

New NIH chief: Turn science into better care, fast
Yahoo News!
The new director of the National Institutes of Health says he won't inject his religious convictions into medical research while pushing cutting-edge science into better bedside care. Read More...

Francis Collins To Direct NIH
Chemical and Engineering News
President Obama picks former genome institute leader for top spot.
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FDA, European Medicines Agency Launch Good Clinical Practices Initiative Collaborative effort aims to ensure appropriate conduct of clinical trials
FDA Release
The U.S. Food and Drug Administration and the European Medicines Agency (EMEA) today announced an agreement to launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly. Read More...

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July

Obama enacts new U.S. stem cell research rules
Reuters
U.S President Barrack Obama directed federal agencies on Thursday to enact new rules governing federally funded research on human embryonic stem cells. Read More...

NCI to Fund Early Detection Research Network Grants
GenomeWeb News
The National Cancer Institute will fund numerous grants to support its Early Detection Research Network, which is a national consortium focused on discovering, developing, and validating biomarkers for early cancer detection, risk assessment, and molecular diagnosis and prognosis of early cancer.
Read More...

NIH Funding Opportunity-II
NIH Release
Recovery Act Limited Competition: Small Business Catalyst Awards for Accelerating Innovative Research (R43). Read More... 

NIH Funding Opportunity Announcements
NIH Release
Recovery Act Limited Competition: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3).
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House Passes Proposed 3 Percent NIH Funding Increase
GenomeWeb
The US House of Representatives on Friday passed a 2010 budget for the Departments of Labor, Health and Human Services, and Education that would increase funding for the National Institutes of Health by nearly $1 billion over its appropriation for 2009. Read More...

U.S. VC's want extended protection for biologics
Reuters
Venture capital critical to biotechnology companies would dry up if biologic medicines did not have extended protection from generic competition.
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Regenerative medicine group launches in D.C.
Washington Business Journal
Thirteen institutions created the Washington, D.C.-based Alliance for Regenerative Medicine. The lobby group will seek support from lawmakers, the public and media for stem cell research. Read More... 

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