November 21, 2011 |
For patients paralyzed by spinal cord injuries, Geron Corp.'s stem cell research was the shining hope. The biotech firm showered scientists with millions of dollars to develop a treatment to reverse spinal damage. The therapy was the first treatment derived from embryonic stem cells to be cleared by the Food and Drug Administration for testing in humans. But last week, Geron abruptly pulled the plug on its pioneering trial and the rest of its stem cell business, including early work on treatments for heart ailments, diabetes and other diseases.
November 18, 2011 |
The Food and Drug Administration has announced that it is revoking approval for the cancer drug Avastin for treatment of breast cancer. Here are some facts about the drug. What is Avastin? Avastin (bevacizumab) is a so-called biological therapy and the first drug approved by the FDA that was designed to inhibit growth of blood vessels feeding tumors. Who makes it? Avastin is made by the biotechnology company Genentech, headquartered in South San Francisco. How does Avastin work?
November 18, 2011 |
The cancer drug Avastin should not be used to treat breast cancer that has spread to other organs because it doesn't help patients enough to justify its risky side effects, the Food and Drug Administration ruled Friday. The decision comes five months after an FDA advisory committee recommended that the federal agency withdraw its approval of Avastin for breast cancer patients. Clinical trial results have fueled doubts for years about its value for treating breast cancer. Still, FDA Commissioner Margaret A. Hamburg said the choice was difficult because so many women and their doctors have put their faith in the drug and lobbied hard on its behalf.
November 14, 2011 |
A crucial cancer drug has been in short supply since midsummer - and its maker, Johnson & Johnson Inc., has not been able to remedy the situation since. The medicine, Doxil, is used to treat patients with ovarian cancer, multiple myeloma or Kaposi's sarcoma after first-line treatments have failed. In July, J&J's Janssen division sent a letter to healthcare providers warning of the shortage and advised against prescribing it to new patients. In August, the drug company sent out another letter announcing a patient registry for Doxil so that they could wait in line, so to speak, for supplies of the drug as they became available.
November 10, 2011 |
A drug born of a revolutionary approach to cancer treatment causes rapid weight loss and improved metabolic function in monkeys, scientists have found. Coming in the wake of multiple setbacks for proposed diet drugs, the early success of a peptide dubbed "adipotide" by its creators may open a new front in the war against obesity, several researchers said. The study, published Wednesday, describes trials in which three species of primates responded to injections of the synthetic peptide by eating less, shedding belly fat and showing changes in metabolic function likely to keep at bay Type 2 diabetes — a frequent consequence of obesity.
November 2, 2011 |
Imagine that you had a type of cancer that could be cured with chemotherapy - but supplies of the drug were limited, and you might not get it. This is the scenario facing an unknown number of patients who normally would depend on drugs like paclitaxel (Taxol), doxorubicin (Doxil), vincristine (Oncovin), methotrexate(Trexall, Rheumatrex), leucovorin and bleomycin (Blenoxane). On Monday, President Obama signed an executive order directing the Food and Drug Administration to take steps to help resolve such shortages.
September 27, 2011 |
When is the exchange of scientific data a possible case of insider trading? When the safety and effectiveness of cancer drugs are tested in advanced clinical trials, says a study published Tuesday in the Journal of the National Cancer Institute. In an unusual study that merged the worlds of medicine and finance, Canadian researchers have turned up an ethical and legal quandary for those who conduct and publish biomedical research: While scientific inquiry demands openness, fortunes ride on its findings, especially for those who can get those findings early.
June 30, 2011 |
A panel of advisors to the Food and Drug Administration voted 6 to 0 to halt the use of the cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose. The recommendation Wednesday came after two days of testimony from patients, doctors and advocacy groups. The panel heard several tearful accounts, like that of Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday. "I'm a testament that the drug does work....
June 28, 2011 |
Whether the cancer drug Avastin should be revoked as a treatment for advanced breast cancer is the subject of both passion and debate. Some breast cancer patients and doctors desperately want the drug to remain available; the FDA is holding hearings on the matter Tuesday and Wednesday. The drug’s maker, Genentech, seeks to convince an FDA panel that Avastin’s benefits outweigh its risks. The FDA isn’t yet convinced . The back-and-forth on the drug’s approval has been a rare challenge to the FDA’s authority to judge the effectiveness and safety of a drug, as a CNN article notes.