December
FDA: Here’s How to Develop Drug Combinations
Wall Street Journal
The FDA today issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. Read More...
NIH director wins bid for translational medicine centre
Nature.com
Sixteen months after taking charge of the US National Institutes of Health (NIH), the world's largest funder of biomedical research, director Francis Collins is now on course to lead the agency through its most significant evolution to date. Read More...
October
The FDA Ignores Its Advisors A Quarter Of The Time
Forbes.com
Before a new medicine is approved by the Food and Drug Administration, it is usually subjected to the scrutiny of a panel of experts selected by the FDA who then vote on whether or not the product should actually be made available for sale. Read More...
FDA issues final rule on safety information during clinical trials
Fierce Biotech
The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. "This final rule will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics," said Rachel Behrman, M.D, associate director for medical policy in the FDA's Center for Drug Evaluation and Research. "These changes will better protect people who are enrolled in clinical trials." Read More...
September
Judges offer ESC research programs a reprieve
Fierce Biotech
After painting a dire picture of the sudden uncertainty that has afflicted dozens of important embryonic stem cell research projects now under way, a three-judge federal appeals panel has decided that the NIH can continue to funnel cash to investigators until a legal challenge to the ban on government support is resolved. Read More...
FDA calls for hearing on biosimilars legislation
TheHill.com
The Food and Drug Administration will hold a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products, according to a draft document circulating among healthcare lobbyists. Read More...
August
Md. biotechs laud $2B federal funds hike
Baltimore Business Journal
A new federal plan that provides nearly $2 billion in biotechnology funding could help existing and emerging companies get their products to market.
Read More...
U.S. to Freeze New Grants After Stem-Cell Decision
Wall Street Journal
Blindsided by a court ruling blocking federal funding for research involving human embryonic stem cells, the U.S. government plans to freeze all new grants for scientists and impose other restrictions on this burgeoning area of science. Read More...
Senate bill would encourage drugs targeting rare kids' diseases
The Hill
A group of bipartisan senators this week introduced legislation to entice drug makers to focus more intently on cures for uncommon children's diseases.
Read More...
July
Think tank calls for FDA to forgo approval of drugs cleared by European regulator
The Hill
The free-market Pacific Research Institute argues in a new report that American patients would benefit if the Food and Drug Administration didn’t have a monopoly on regulations. Read More...
NIH chief lobbies for $500M fund to back clinical trials
Fierce Biotech
NIH chief Francis Collins is lobbying Congress to set aside a half-billion dollar fund that will give start-up biotechs up to $15 million to bankroll clinical trials for new drugs that treat neglected diseases. The initiative marks a strategic shift for the NIH, which has played a big role sponsoring the academic research that often winds up in developers' hands. Read More...
June
Developers lobby for new federal R&D incentives for rare diseases
Fierce Biotech
Charged with spurring greater R&D efforts on new drugs for rare diseases, the FDA's newly formed rare disease review group plans to meet today and tomorrow and will hear about a host of new ideas on a richer set of research incentives. Read More...
Which FDA Advisory Committee is the Toughest?
Wall Street Journal
While the recommendations of the FDA’s advisory committees aren’t binding, the agency usually follows their advice. So the track records of those committees, analyzed in a new research note from Concept Capital’s Washington Research Group, are of interest. Read More...
May
Rejected Drugs May Be Disclosed by FDA for First Time
Bloomberg.com
Drug rejections, plant inspections and detailed side-effect reports would be shared with consumers for the first time under a new plan from U.S. regulators. Read More...
Johansson to testify before Congress on lending bills
Baltimore Business Journal
Christian S. Johansson, secretary for the Maryland Department of Business and Economic Development, will testify Tuesday on Capitol Hill in favor of federal legislation that would help small businesses with a proven track record secure loans. Read More...
April
FDA seeks new disclosure from panel members
Bloomberg.com
The U.S. Food and Drug Administration would disclose which companies or institutions create a potential conflict of interest for advisory panel members, under a proposal posted Wednesday on the agency's website. Read More...
Cancer Research by U.S. Disorganized, Underfunded, Study Says
Bloomberg.com
The U.S. government’s cancer research network is “approaching a state of crisis” as waste and inefficiency cause 40 percent of late-stage trials it funds to be abandoned before completion, a report found. Read More...
March
WSJ: FDA mapping new, faster path for cocktail drugs
Fierce Biotech
The FDA has set its sights on a new and faster development pathway for drug cocktails, which could have a big impact on the therapeutic prospects for a slate of major diseases like cancer, AIDS, tuberculosis and hepatitis. And the Wall Street Journal reports that the initiative has helped inspire a major new development collaboration among pharma companies that will soon be announced. Read More...
February
FDA creates partnership to boost regulatory science
Los Angeles Times
The Food and Drug Administration and the National Institutes of Health on Wednesday announced a plan to help the FDA make swifter decisions about the safety and effectiveness of new products and procedures that flow from advanced research. Read More...
NIST Grants Awards for Recovery Act Fellowship Programs
NIST News Release
The U.S. Commerce Department's National Institute of Standards and Technology (NIST) announced today that it is awarding a total of $20 million to the University of Maryland and the University of Colorado to develop and implement NIST measurement science and engineering fellowship programs. The new fellowship programs were funded under the American Recovery and Reinvestment Act (ARRA) of 2009. Read More...
January
Researchers Find Study of Medical Marijuana Discouraged
NY Times
Despite the Obama administration’s tacit support of more liberal state medical marijuana laws, the federal government still discourages research into the medicinal uses of smoked marijuana. Read More...
Obama at odds with some Dems on key provision in healthcare
The Hill
President Barack Obama is looking to change a key healthcare reform provision passed by both the House and Senate, triggering a dispute with some lawmakers in his own party; governors rush to defense of bipartisan biologics deal. Read More
Study: Biomedical research funding is slowing
FierceBiotech
After a decade of doubling, the rate of increase in biomedical research funding slowed between 2003 and 2007. Adjusting for inflation, the absolute level of funding from the NIH and industry appears to have decreased by 2 percent in 2008, according to a study in the Journal of the American Medical Association. Read More...
NIH Awards Over $5,000,000 for Tβ4 Research in 2009/2010
BusinessWire
REGENERX announced today that National Institutes of Health (NIH) has awarded 12 research grants totaling over $5,000,000 for the study of Tβ4 in 2009/2010. Many of these grants will be going to collaborators.
Read More...
Study: Biomedical research funding is slowing
FierceBiotech
After a decade of doubling, the rate of increase in biomedical research funding slowed between 2003 and 2007. Adjusting for inflation, the absolute level of funding from the NIH and industry appears to have decreased by 2 percent in 2008, according to a study in the Journal of the American Medical Association. Read More...