Bristol-Myers Squibb’s Immunotherapy Drug Opdivo Falls Short In Clinical Trials
The trial was designed to broaden the use of this promising cancer drug. Meanwhile, AbbVie and Amgen clash over Humira copy.
The New York Times:
Immunotherapy Drug Opdivo Fails Clinical Trial To Expand Use
The hot new field of immunotherapy got a shock on Friday when a best-selling new drug failed as an initial treatment for lung cancer in a clinical trial. Bristol-Myers Squibb said Friday that the drug, Opdivo, had not slowed the progression of advanced lung cancer in the clinical trial, which compared it with conventional chemotherapy. That is likely to crimp the overall sales of the drug by a significant amount. (Pollack, 8/5)
The New York Times:
Bristol-Myers Squibb’s Hubris Cost It $21 Billion
Bristol-Myers Squibb has suffered a $21 billion self-inflicted wound. The amount is the value that investors wiped off the pharmaceutical company on Friday morning after its trial to greatly broaden the use of one of its most promising cancer drugs failed. It was an unnecessarily risky move for Bristol, whose immunotherapy has been outselling Merck’s. The stumble will allow its more cautious rival to clean up. (Cyran, 8/5)
The Wall Street Journal:
AbbVie Files Patent Suit Over Amgen’s Copy Of Humira
Drugmaker AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc., seeking to block sales of a lower-priced replica of AbbVie’s top-selling drug, Humira. The lawsuit, filed late Thursday in federal court in Delaware, alleges Amgen’s copy of the biotech drug Humira violates many of AbbVie’s patents on the anti-inflammatory treatment. The suit asks the court to keep the copy off the market if it gains approval by the Food and Drug Administration. (Rockoff, 8/5)
In other news —
NPR:
Medications Are Seldom Tested For Safety In Pregnancy
The CDC estimates that 70 percent of pregnant women in the U.S. take at least one prescription drug — whether it's for something like colitis or diabetes, or just allergies. And a lot of them are stuck in the same spot as Mottola, wondering if the drugs they need might do any harm, says Maggie Little, a bioethicist at Georgetown University. "There's actually shockingly little that we know about how to treat illness during pregnancy," she says. (Bichell, 8/8)
The Wall Street Journal:
NIH Closes In-House Pharmacy Faulted For Sterility Processes
The National Institutes of Health said it is permanently closing one of two pharmacies that were the subjects of critical reports over their sterility processes a year ago after inspections by the Food and Drug Administration. Both drug-production facilities are located in the NIH Clinical Center, the NIH’s renowned hospital that largely treats patients who are entered in clinical studies there. (Burton, 8/5)
