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U.S. food and drug administration 60 articles

Johnson & Johnson’s new diabetes drug shows promise in late-stage clinical trials

A new experimental drug made by Johnson & Johnson has demonstrated a better ability to lower blood sugar levels in patients with diabetes than Merck’s Januvia and the older, more conventional drug glimepiride, data from a couple of late-stage clinical trials of the drug have shown. Results of the studies, which were conducted over 52 weeks and involved more than 10,000 patients, also found the new Johnson & Johnson drug, canagliflozin, contributed to weight loss in patients better than Januvia and glimepiride (marketed as Amaryl and GLIMY) and was linked to fewer incidents of hypoglycemia, a dangerous drop in blood ... Read More

Canadian study finds Actos doubles bladder cancer risk

Patients who take the diabetes drug Actos (pioglitazone) two years or longer are twice as likely to develop bladder cancer than those who haven’t taken the drug, Canadian researchers have found. The Canadian study, led by Montreal epidemiologist Dr. Laurent Azoulay and published online in the British Medical Journal, analyzed the medical records of nearly 116,000 patients in Great Britain newly treated with diabetes drugs between 1988 and 2009. The records were consolidated in Great Britain’s General Practice Database from about 600 general practices in that country. The researchers found that while absolute risk of developing bladder cancer was relatively ... Read More

Actos drugmaker consolidates its California facilities

Japanese drugmaker Takeda, whose diabetes drug Actos faces patent expiration, declining sales, and mounting personal injury lawsuits, is closing its San Francisco research facilities, the San Francisco Business Times reports. Takeda’s San Francisco research operations once played a key role in the company’s development of early-stage antibody drugs. The drugmaker announced late last year that it would be consolidating its California-based facilities, but did not disclose how the move would affect the San Francisco site. According to the Business Times, Mary Haak-Frendscho, president of Takeda San Francisco, recently took a job as executive chairman of a San Francisco-based Compugen Ltd. ... Read More

Former Actos patient sues Takeda over bladder cancer injuries

A West Virginia man is the latest person to file a lawsuit against Japan-based Takeda Pharmaceutical Company over injuries he alleges were caused by taking the diabetes drug Actos for years. According to the Consumer Justice Foundation, the plaintiff, Donald Shingleton, began taking Actos in 2005 to treat his type 2 diabetes. After years of controlling his body’s insulin levels with Actos, however, Mr. Shingleton developed bladder cancer. He now seeks damages for his injuries and the emotional distress he says he has endured as a result of taking the drug. Mr. Shingleton filed his lawsuit April 25 in U.S. ... Read More

Takeda’s new diabetes drug fails to clear FDA

The U.S. Food and Drug Administration has again rejected a new diabetes drug called alogiptin made by Actos manufacturer Takeda Pharmaceuticals, saying the company needs to provide more information about the drug’s performance in other countries. The setback could deal a significant financial blow to Takeda, the largest pharmaceutical company in Asia, as its beleaguered drug Actos, used to treat type 2 diabetes, loses its patent protection later this summer. Takeda has been poising alogiptin to replace Actos as its next widely prescribed blockbuster drug. FDA regulators originally rejected Takeda’s alogiptin in 2009 on the basis that not enough information ... Read More

Actos maker Takeda buys U.S. gout drug manufacturer

Japanese pharmaceutical giant Takeda, which produces the controversial diabetes drug Actos, is expanding its U.S. reach with an $800-million takeover of URL Pharma Inc. The move comes as Takeda’s U.S. profits are set to contract after Actos loses its patent protection later this year. Among other drugs, Philadephia-based URL manufactures Colcrys, an oral drug that is used to treat gout flare-ups. Colcrys is URL’s top moneymaker, earning the company $430 million in revenue last year. Takeda is Japan’s largest pharmaceutical company, but most of its sales revenues come from the United States, according to the Associated Press. Its top-earning drug ... Read More

FDA plans 2-day metal hip device review

Responding to growing concerns over complications associated with metal-on-metal hip implant devices, the U.S. Food and Drug Administration (FDA) said it has planned a two-day review of the devices in June that could result in tougher regulations. A global recall of two different all-metal hip implants made by DePuy Orthopaedics in 2010 compounded fears that such devices could fail prematurely and harm recipients, sometimes in serious, debilitating ways. A number of other companies manufacture metal-on-metal hip implants, but most complaints center around DePuy’s ASR XL Acetabular and Hip Resurfacing systems. “We are asking outside scientific and medical experts to discuss ... Read More

FDA to scrutinize metal-on-metal hips in June

Signaling more trouble for metal-on-metal hip devices and their manufacturers, the U.S. Food & Drug Administration (FDA) announced it has planned a 2-day review of the controversial medical devices, which have become the subject of thousands of personal injury lawsuits around the world. “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement. Hip replacement systems made with all metal components were first conceived about ... Read More

Gardasil distribution stalled in France pending government-ordered study

The distribution of Merck’s human papillomavirus (HPV) vaccine Gardasil has been halted in France, where a government-appointed group of immunologists and other researchers has been formed to determine if the benefits of the vaccine are worth the risks. As in the United States, Gardasil has become a “thorny subject” in France, with many parents suspicious of the vaccine’s benefits and fearful of its risks, according to France’s Le Point. Data pulled from the U.S. Vaccine Adverse Event Reporting System (VAERS) shows that from the time Gardasil was introduced in 2006 until September 15, 2011, 20,096 adverse events following the vaccine ... Read More

Group offers support network for girls injured by Gardasil

Girls who believe they have been harmed by Merck’s human papillomavirus (HPV) vaccine and their families shouldn’t have to feel alone when dealing with the devastating effects many people believe the drug can have, thanks to an international outreach of volunteers who can help answer questions and provide emotional support. The Guardian Angels, a support group encompassing 23 states and eight countries (including the United States), is made up of 42 volunteers who share knowledge and even personal — in some cases tragic — experience with the Gardasil vaccine. “We would eventually like to have a Guardian Angel in every ... Read More