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breast cancer 116 articles

FDA panel rejects non-hormonal menopause treatment

An experimental non-hormonal treatment for menopause was rejected by a Food and Drug Administration advisory panel this week because the group found risks associated with the drug were greater than any benefit it offered. Drug maker Depomed submitted for approval Seflsa, known generically as gabapentin, a medication that has long been used to treat pain and seizures. It is also prescribed off-label by doctors to treat menopause symptoms. Depomed asked the FDA to approve this use, which would allow the company to market it as a menopause treatment. The panel’s decision to vote against approving Seflsa is based on studies that ... Read More

FDA approves new type of breast cancer treatment

The Food and Drug Administration (FDA) has approved a first-of-a-kind breast cancer cocktail designed to kill tumor cells while sparing healthy ones. The new drug, Kadcyla, made by Roche, contains Herceptin, an established breast cancer treatment, with a powerful chemotherapy drug, and a third chemical that binds the two medicines together. Researchers say the Kadcyla may be more beneficial for some breast cancer patients because it delivers more medicine and has fewer side effects. Kadcyla is indicated for patients with HER2-positive breast cancer, an aggressive form of the disease that generally does not respond well to hormone therapy. About 20 ... Read More

Drug study data often crunched to mask serious side effects

Clinical drug trials provide important data that help the Food and Drug Administration (FDA) determine if a drug is safe and effective enough to be marketed in the United States for a particular indication. But a new study has found that sometimes drug companies crunch numbers in a way to make a drug look better than it actually is. Researchers at Princess Margaret Cancer Centre reached that conclusion after reviewing data from 164 breast cancer trials. They found that a large number of the studies that reported no real benefit of a particular treatment were spun so that they focused ... Read More

Eli Lilly settles breast cancer lawsuit over DES pregnancy drug

Eli Lilly and Co. has settled a lawsuit from four sisters who say its drug, DES, or diethylstilbestrol, taken by their mother during pregnancy to prevent miscarriage and preterm birth, caused them to develop breast cancer. The agreement could trigger more financial settlements in as many as 50 similar lawsuits waged against Eli Lilly and other drug companies who sold DES. DES is a synthetic estrogen that was used during the 1930s through 1970s. It was eventually pulled from the market after it was found to cause a rare vaginal cancer in the daughters of women who took the drug ... Read More

Four sisters file lawsuit against pregnancy drug claiming it cased them breast cancer

Four sisters have filed a lawsuit against Eli Lilly and Co., claiming that its drug DES, or diethylstilbestrol, taken by their mother during pregnancy to prevent miscarriage and preterm birth, caused them to develop breast cancer. The drug, a synthetic estrogen, was used during the 1930s through 1970s, but was eventually pulled from the market after it was found to be linked to rare vaginal cancer in women whose mothers used DES. All four Melnick sisters experienced miscarriages, fertility problems or other reproductive tract problems that were suspected to have been caused by prenatal exposure to DES. Each of the ... Read More

Metformin may increase survival in women with ovarian cancer

The diabetes drug Metformin may help women with ovarian cancer live longer, according to a new study published in the journal Cancer. The study showed that women who had ovarian cancer who took Metformin for diabetes treatment had a 20 percent better survival rate from their cancer than women who did not take Metformin. The study compared the survival of 61 patients with ovarian cancer who were also taking Metformin and 178 ovarian cancer patients who were not taking metformin. Sixty-seven percent of the patients who took Metformin were still surviving after five years compared to 47 percent of those ... Read More

Europe approves new diabetes drug despite bladder, breast cancer risks

European drug regulators have approved the experimental drug Forxiga, known by the generic name dapagliflozin, a once-daily pill for adult type 2 diabetes. It is the first drug approved in a new class of medications called SGLT2 inhibitors. The same drug was rejected in January by the U.S. Food and Drug Administration (FDA) because of concerns that the medication increased the risk of bladder cancer and breast cancer. Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. During clinical trials nine out of 5,478 patients who were taking the drug were diagnosed ... Read More

Novel new type 2 diabetes drug may be safer than others on market

Lexicon Pharmaceuticals is hoping its novel new diabetes drug LX4211 will win approval from the Food and Drug Administration (FDA) and stand out in a sea of diabetes treatments with questionable safety records. LX4211 is a once-daily pill that belongs to a class of diabetes drugs known as sodium-dependent glucose transporter (SGLT) inhibitors. These drugs work by blocking the reabsorption of glucose into the bloodstream and instead excrete glucose in the urine. LX4211 inhibits SGLT-1, the primary transporter of glucose from the gastrointestinal tract, and SGLT-2, the transporter of glucose from the kidneys back into the bloodstream. Other SGLT drugs, ... Read More

FDA to review drugs in new class of type 2 diabetes medications

Two type 2 diabetes drugs in a new class of blood sugar lowering medications known as SGLT2 inhibitors are hoping to win approval from the Food and Drug Administration (FDA) – Johnson & Johnson’s canagliflozin, and empagliflozin, made jointly by Eli Lilly and Boehringer Ingelheim. The drug makers presented the benefits of their medications recently at the European Association for the Study of Diabetes meeting in Berlin. The two drugs are among several of their kind for the treatment of diabetes, and are in various stages of development. The FDA is currently reviewing data for canagliflozin, and it is expected ... Read More

Drug company stock drops after news that drug data was flawed

It was a great day for Peregrine Pharmaceuticals when earlier this month during a midpoint review of a clinical trial the company announced that lung cancer patients taking its experimental drug bavituximab were living twice as long as patients who were treated with chemotherapy alone. The company’s stock shot up and last Friday had reached a three-year high. Monday, however, the price of Peregrine stock plummeted after news of a major discrepancy between some patient sample test results and treatment code assignments. Bavituximab is being studied as a second option for non-small cell lung cancer and as a primary treatment ... Read More