Tag:
adverse events
Latest Headlines
Latest Headlines
CSL nets closeout letter after FDA violations
After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, receiving a closeout letter from the FDA.
Vax maker CSL on road to GMP compliance
The common vaccine-making process of blending flu virus strains appears to have been a factor in the nearly 10% adverse reaction rate to CSL's Fluvax among children last year. Intermingling of the
Supreme Court OKs biotech lawsuits based on adverse events
Biotech companies have one more potential legal liability to consider as they push a new drug to the marketplace. The U.S. Supreme Court has ruled that a failure to report relevant instances of
CSL shares plunge on flu vax safety concerns
Shares of Australia's CSL plunged earlier this week after word that the influenza shot Fluvax is potentially dangerous for children and could be linked to hundreds of adverse reactions in that
Vax will likely trigger tsunami of adverse event claims
Once public health officials start their mass swine flu vaccination campaigns in October, they'll be bracing for a deluge of complaints about adverse events--most of which won't have anything to do
GAO: FDA regulators can't track adverse event reviews
The FDA can't reliably forecast just how much money it needs to operate, says a new Government Accountability Office report, because it can't even track how many adverse drug and device events it
Halozyme shares slide on osteoporosis program failure
Halozyme Therapeutics is dumping an early-stage osteoporosis program after witnessing severe site injection reactions. Investors--in no mood for setbacks, no matter how early in the development
Aastrom halts mid-stage trial after patient death
Aastrom Biosciences shares slid 24 percent Friday morning on the news that the company halted a mid-stage trial for a congestive heart failure treatment following the death of a patient. The Ann
Pharmasset halts Hep B trial after adverse events
Pharmasset announced today that the company has halted a late-stage study for its experimental chronic hepatitis B treatment clevudine. According to the the Princeton, NJ based company, a number of
CDC to modernize VAERS
With the heat on to monitor the safety of vaccines, the CDC is calling for a new electronic system that can swiftly gather reports of adverse events from around the country. Right now 80 percent of
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