March 21, 2013 |
A compounding company in Augusta, Ga., has recalled syringes of the cancer drug Avastin it supplied over five months to physicians treating vision problems after the Food and Drug Administration received word that five patients who received the compounded medication came down with eye infections that could leave them blind. The FDA announced the recall Thursday after regulators conducted a preliminary inspection of Clinical Specialties Compounding Pharmacy and found "practices at the site that raise concerns about a lack of sterility assurance.
November 14, 2010 |
Question: I have heard many good things about Roche Holding. Is it a good investment in light of the new healthcare law? Answer: This Swiss pharmaceutical firm has lost some investment luster. The company has an array of cancer-fighting biotechnology drugs, but its once-robust sales growth has been slowing, the threat of cheaper generic drugs is growing, and the company has suffered setbacks in drug development. To improve its outlook, the company is turning to cost-cutting, with staff reductions expected in a number of markets.
December 4, 2007 |
The Food and Drug Administration will ask outside experts Wednesday whether Genentech Inc.'s Avastin should be approved to treat breast cancer, despite mixed results in company studies. After reviewing the South San Francisco firm's data, the agency said patients on Avastin and chemotherapy had slower cancer progression but did not survive longer overall than patients on chemotherapy alone. Shares of Genentech fell $2.75, or 3.6%, to $73.50.
July 9, 2003 |
Swiss drug maker Roche Holding said Tuesday that it acquired rights to sell Genentech Inc.'s promising experimental colon cancer drug Avastin outside the U.S. Roche owns 59.8% of Genentech, a biotechnology company based in South San Francisco. The Swiss firm has first refusal on international rights to Genentech products, and it already sells Genentech cancer drugs Herceptin and Rituxan abroad. Avastin could receive U.S. regulatory approval this year.
September 26, 2006 |
Genentech Inc. has added warnings about a rare brain condition called reversible posterior leukoencephalopathy syndrome, or RPLS, in patients using its cancer drug Avastin, the Food and Drug Administration said. The drug's label also now includes information about seven reports of patients who developed holes inside the nose called septum perforations, the FDA said.
September 24, 2005 |
Genentech Inc. halted a clinical study Friday after ovarian cancer patients taking the drug Avastin suffered serious side effects. After the announcement, Genentech's shares fell. Avastin, already approved for the treatment of colon cancer, is considered Genentech's most promising drug, so investors are sensitive to bad news. Genentech said it stopped accepting participants in the ovarian cancer study after five of 44 patients suffered bowel tears.
June 28, 2006 |
Researchers stopped a test of Genentech Inc.'s Avastin cancer drug after the medicine failed to prolong the lives of patients with pancreatic cancer. An independent safety panel told the National Cancer Institute that patients were unlikely to benefit from the treatment, the South San Francisco-based company said. Genentech and partner Roche Holding are proceeding with other studies of Avastin in pancreatic cancer, a Genentech spokeswoman said.
November 18, 2011 |
U.S. drug regulators Friday withdrew approval of Roche's Avastin as a treatment for breast cancer, capping a protracted and emotional battle over a drug backed by many survivors of the disease. U.S. Food and Drug Administration Commissioner Margaret Hamburg said Avastin has not proven safe and effective for breast cancer. The drug will remain on the market for other uses, such as treating types of colon, lung, kidney and brain cancer. Advisers to the FDA paved the way for Friday's decision, recommending against Avastin's use in breast cancer in June.
October 17, 2005 |
Beverly Hills eye specialist Edgar Thomas swabbed his patient's eye with anesthetic and reached for a syringe. "Now hold very still for me," he told Cecilia Blackfield, as he inserted the needle into the corner of the 90-year-old woman's right eye. The syringe contained Avastin, a Genentech Inc. drug approved to treat advanced cases of colon cancer.