Jane Axelrad, FDA’s associate director of CDER at the time, wrote that, “we
usually find ourselves dealing with situations where sponsors want to minimize
the risk information.” According to Axelrad, preemption wouldn’t be “consistent
with the agency’s role in protecting the public health.” …
Year: 2008
Team uses molecular switch to erase memories
The “work reveals a molecular mechanism of how [memory deletion] can be done
quickly and without doing damage to brain cells,” …
NEWS: New public genome database to spark research, unease (BioTechniques Int.)
Though dissenting opinions on the appropriateness of a person’s complete, public
genome are widespread in response to PGP’s approach, the 10 volunteers’ full
genomes are far from being completely sequenced: the privately-funded project is
focusing on only a handful of genes that seem to have the most influence over
disease, behavior, and physical traits. …
Harvard researchers use chemical to transform human skin cells into pluripotent cells
Using valproic acid, a chemical often used as a medication to treat seizure
disorders, the scientists loosened the chromatin—the packaging of the cellular
chromosome—making it easier to alter the cell’s DNA to transform ordinary human
skin cells into more powerful induced pluripotent cells, or iPS cells. …
Adverse event reports hit record high
The Institute took its stats from the FDA’s adverse events reporting system,
which can be problematic for a couple of reasons. One, adverse events often go
unreported, so the numbers can understate the problem. But–and this is the
second reason–the individual reports don’t prove that the drug caused the
problem. …
Deprived Of A Sense Of Smell, Worms Live Longer
In the long term, Kornfeld’s goal is to identify compounds that could
potentially delay human aging. …
Study: Half of doctors use placebo
They said they used placebo treatments several times a month, and usually
described the pill or injection as “a potentially beneficial medicine not
typically used for your condition.” …
Reading the Entire Genetic Code
the system is able to sequence parts of the genome that contain many repeated
letters, which are virtually impossible to read now. By next year, the company
hopes to be selling sequencing machines. …
Lilly: $1.4B ding in profits for Zyprexa charge
Eleven states that were not part of the initial 32-state probe have also filed
lawsuits over the atypical antipsychotic medication, which the company launched
in 1996. …
Scientists develop drug delivery system for brain cancers, other diseases (FierceBiotech)
scientists in the company and collaborators in the US and Canada found that the
drug was transported rapidly across the blood-brain barrier and into the
functional part of the brain, the parenchyma. …