Survey Shows Lack of Confidence at FDA
About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency’s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
Bill Aims to Protect Joint Patents
Patents that result from collaboration between universities and companies won new protections from legal challenge under legislation that passed Congress over the weekend.
Trouble for California Cloning?
The United Nations will likely decide Friday, after many delays, whether to vote on an international cloning ban, vote on a new declaration introduced by Italy or delay voting once again.
Just weeks after Californians voted for a $3 billion proposition to fund embryonic stem-cell research, which would include therapeutic cloning, the United Nations is considering a ban on all cloning. If the vote leads to a treaty that’s eventually adopted by the United States, the treaty could cause problems for the California Stem Cell Research and Cures Initiative.
The Murky History of Merck’s Vioxx
Merck’s decision to withdraw its popular arthritis drug Vioxx from the market in late September has raised questions about the process leading up to its regulatory approval in 1999 as well as the importance of subsequent medical studies.
Here are some key dates in the Vioxx saga:
Contingency Plans Help Current Merck Crisis
In the wake of Merck & Co.’s announcement to pull Vioxx off the market, the pharmaceutical giant pressed forward with plans to launch new products … The fact that companies such as Merck & Co. can quickly bounce back from troublesome corporate crises is a testament to their strong contingency planning.
Reviewing Drug Safety
“The Food & Drug Administration has announced a major review of its system for monitoring the safety of drugs already on the market. FDA will sponsor an Institute of Medicine study of the agency’s safety monitoring procedures, and it will set up a formal program to make sure that the views of dissenting agency scientists are heard.”
The Stem Cell Gold Rush:
Scientists around the country who study embryonic stem cells may be mourning four more years of President Bush’s restrictive funding policy, but California scientists are throwing a party, and top researchers in less-funded states are hoping for invitations.
Biotech: The “safe” drug bet?
“Defensive pharma stocks have struggled while biotechs have flourished. Can this continue?”
Biotech execs have a sense of humor about elusive profits
When Ernst & Young’s annual report on the biotechnology industry last year predicted that as a whole, the industry would turn profitable for the first time in 2008, some long-term industry veterans gave a knowing heard-that-one-before chuckle.