adverse events

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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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