DRUGMAKERS: FDA ISSUES WARNINGS ON TWO DRUGS
Federal officials warned doctors yesterday not to prescribeThis is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
Hoffmann-La Roche heart drug Posicor for "patients with low heart
rates or who are taking certain cholesterol-lowering drugs," the
Washington Post reports. According to FDA officials, the warning
was released in response to reports about side effects, including
"dangerously lowered heart rates." Separately, the FDA
recommended approval of a new drug for sickle-cell anemia made by
Bristol-Myers Squibb. But the panel warned that patients who
take the drug, called Droxia, could risk getting cancer. The FDA
panel recommended limiting Droxia to "adults with moderate to
severe recurrent painful crises and to those who have had at
least three crises in the last year" (12/19).
CHIRON UPSET
The FDA panel did not vote to approve a cancer drug
(DepoCyt) developed by Chiron Corp. and DepoTech Corp. due to
"lingering questions about whether the clinical trials included
enough patients." Chiron spokesperson Jim Knighton said that the
company was surprised by the decision because the FDA approved
the design of the clinical trials five years ago, the San
Francisco Chronicle reports. The "setback" came one day "after
the full FDA approved another Chiron-developed product,
Regranex." Manufactured by Johnson & Johnson, Regranex "is the
first bioengineered treatment for healing diabetic foot ulcers"
(Kazakoff, 12/19).
ON THE MOVE
Pharmacia & Upjohn Inc. announced yesterday that it will
move its global headquarters to Bridgewater Township, NJ, the
Bergen Record reports. Company officials anticipate that the new
headquarters will be ready in late spring. The site was selected
because it is near other pharmaceutical companies and "is within
an hour's drive of Newark International Airport" (Gerena-Morales,
12/19).
NEW AIDS DRUG
Farmingdale, NJ-based Enzo Biochem announced yesterday that
it has filed an application with the FDA to begin clinical
testing of new type of "gene therapy designed to stop the
progression of HIV in people who are infected," Dow Jones News
Service/Newsday reports. The company said the clinical trial
will be conducted at the University of California at San
Francisco (12/19).