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experimental drug 24 articles

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

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

Study on hepatitis C drug halted after patient suffers heart failure

Bristol-Myers Squibb Co. pulling the plug on a study for a drug to treat hepatitis C after a patient suffered heart failure. The drug BMS-986094, formerly known as INX-189, was in Phase II trials. The drug is a nucleotide polymerase inhibitor, or “nuke.” The drug was being tested as a treatment for hepatitis C, a viral disease that leads to inflammation of the liver. Chronic infections can lead to scarring of the liver and ultimately to cirrhosis. In some cases, those with cirrhosis will go on to develop liver failure, liver cancer, or life-threatening esophageal and gastric varices. The disease ... Read More

Colorectal cancer drug gets FDA priority review

An experimental cancer drug will get priority review by the Food and Drug Administration (FDA) as part of the agency’s effort to speed up the approval process for drugs considered potentially significant therapeutic advancements of existing therapies for life threatening conditions. Typically, it takes drugs 10 to 12 months to go through approval channels with drug regulators. The new expedited process cuts that time in half to about six months. Proponents say the process will help speed lifesaving drugs to the sickest patients. The agency will review Bayer’s colorectal cancer drug regorafenib under the new process. The drug is designed ... Read More

Experimental type 2 diabetes drug shows promise in African American adults

An experimental drug for type 2 diabetes is showing promising results in African American adults in a late-stage clinical trial. The once-daily tablet, marketed by Boehringer Ingelheim as Tradjenta, helped reduce blood sugar levels in patients whose blood sugar had not been previously adequately controlled. It is in a class of medications known as DPP-4 inhibitors, which work different from other diabetes medications by inhibiting glucagon and blood sugar levels. African Americans are at a 77 percent greater risk of developing type 2 diabetes than Caucasians. Nearly 20 percent – or about 4.9 million – African American adults are living ... Read More

Experimental drug shown effective against aggressive skin, lung, kidney cancers

A new experimental drug by Bristol-Myers Squibb is showing promise for patients with advanced melanoma, kidney and lung cancers, according to preliminary trial data. The drug, known now as BMS-936558, is an anti-PD-1 treatment that works by boosting the immune system. Early data shows the drug was relatively safe and effectively shrank tumors in three of the five cancers in which it was tested. Significant tumor shrinkage was noted in 18 percent of the 76 lung cancer patients, 28 percent of the 94 melanoma patients, and 27 percent of the 33 kidney cancer patients in which it was tested. Cancer experts ... Read More

Old drug found to be key treatment for non-Hodgkin lymphomas

A drug developed 50 years ago has reemerged as a new weapon in the fight against certain types of non-Hodgkin lymphomas, more than doubling progression-free survival rates and reducing side effects compared to a multi-drug cocktail that for years has been used to treat indolent non-Hodgkin lymphomas. The drug, bendamustine (Treanda), showed promising results when combined with another therapy, rituximab (Rituxan). Traditionally, the disease has been treated with a combination of five different drugs – rituximab, cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine, and prednisone – called R-CHOP. Findings on bendamustine were presented this week at the annual meeting of the American ... Read More

Patients with aggressive breast cancer granted experimental drugs

Women with highly aggressive, early-stage breast cancers will now be able to try experimental drugs before they have been tested for safety and efficacy in the sickest cancer patients. The new guideline is part of a new push by the Food and Drug Administration (FDA) to speed lifesaving drugs to patients faster. Previous practice was to test cancer drugs on the sickest patients with end-stage disease. If the drug appeared to extend life and slow the progression of the disease, it was then approved for use in patients in earlier stages of breast cancer. But it could take nearly a ... Read More

FDA panel considers benefits, risks of experimental rheumatoid arthritis drug

Drug regulators are questioning whether an experimental drug for rheumatoid arthritis has too great of a cancer risk and whether it actually works as well as the drug company claims. The drug, tofacitinib, marketed by Pfizer, is under review by a Food and Drug Administration (FDA) advisory panel, which will vote whether to recommend the treatment for FDA approval. The FDA isn’t required to follow the advice of its expert panels, but it usually does. Analysts have pegged tofacitinib as a potential blockbuster medication. “Blockbuster drugs” are ones that generate at least $1 billion in revenue for their owner over ... Read More

Panel: Testing should continue on experimental pain killers

Clinical trials on an experimental nerve blockers that relieve pain but can destroy joints should go on as planned, say advisers to the Food and Drug Administration (FDA). Testing on the drugs was halted in 2010 after nearly 500 people taking the medication had to under go joint replacement surgeries. The panel, which voted unanimously to resume testing, said the medication provides a benefit to people with no other treatment options. The drugs, made by Pfizer Inc. and Regeneron Pharmaceuticals Inc., are part of a new class of medications known as nerve growth factors. They work by blocking a protein ... Read More