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Actos 310 articles

FDA delays decision on diabetes inhaler to review possible cancer risks

The Food and Drug Administration (FDA) has delayed its decision about whether to approve Mannkind Corp.’s Afrezza, an inhaled insulin treatment for diabetes, due to concerns about an increased risk of lung cancer. The delay comes just one week after an advisory panel recommended the approval of the therapy for both type 1 and type 2 diabetes under the condition that the drug company collect long-term data on cancer risks and other potential side effects. Afrezza is a whistle-sized device designed to deliver a fast-acting dose of insulin. It offers a convenient alternative for many diabetic patients who currently have to ... Read More

Takeda ordered to pay $9 billion in Actos bladder cancer lawsuit

In a verdict that may be the largest single award in U.S. history involving drug maker liability, Takeda Pharmaceutical Co. and Eli Lilly & Co. were ordered to pay a combined $9 billion in punitive damages after a federal court jury found the companies guilty of covering up bladder cancer risks with its type 2 diabetes drug Actos. Japan-based Takeda was ordered to pay $6 billion while U.S. drug maker Eli Lilly was ordered to pay $3 billion. Under an agreement between the two companies, Takeda may end up shouldering Eli Lilly’s judgment. The lawsuit is the first U.S. trial ... Read More

FDA panel recommends approval of novel inhaled diabetes treatment

An advisory committee for the Food and Drug Administration (FDA) is recommending marketing approval for a novel inhaled drug to treat both type 1 and type 2 diabetes. Afrezza, manufactured by MannKind Corp., is a whistle-sized device that is designed to deliver a more effective, fast acting dose of insulin. The product offers a crucial alternative for many diabetics who currently have to undergo regular injections, which can be both painful and cumbersome. If approved, Afrezza would be the first inhaled insulin therapy in the United States since 2006, when Pfizer introduced Exubera, an inhaler that was discontinued due to ... Read More

Japan approves new type 2 diabetes drug dapagliflozin

Japanese drug authorities have approved Forxiga (dapagliflozin) for the treatment of type 2 diabetes. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, is a once-daily oral treatment that works independent of insulin to help remove excess glucose from the body. It is currently approved in more than 40 countries around the world, including the United States, where it is marketed under the brand name Farxiga. SGLT-2 inhibitors are a relatively new class of diabetes medications. It was the first of its kind to be approved in Europe, and the second, behind Johnson & Johnson’s Invokana, in the United States. The class ... Read More

New diabetes drug gets positive review from European drug advisors

An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance. Earlier this month, the U.S. Food and Drug Administration ... Read More

Participants sought for study on long-term effects of type 2 diabetes drugs

People between 30 and 70 years of age diagnosed with type 2 diabetes within the past five years who take no medication to treat the chronic condition are being sought for a study evaluating long-term effectiveness of diabetes drugs. The study is being conducted at 37 sites across the country and aims to recruit about 5,000 participants. The study, called G.R.A.D.E. – the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study – will compare four medications, each combined with metformin. The National Institute of Diabetes, along with Digestive and Kidney Diseases of the National Institutes of Health, is funding ... Read More

Short-term use, lower doses of Actos linked to increased bladder cancer risk

People who have been treated with the type 2 diabetes medication Actos (pioglitazone) for more than six months may be at greater risk of developing bladder cancer, even if they were on a low dose, according to a new study published in the Journal of Korean Medical Science and reported by Cancer Monthly. In 2011, studies showed long-term use (12 months or greater) of Actos increased the risk for bladder cancer. As a result, some countries banned the drug. The U.S. Food and Drug Administration (FDA) ordered that Actos and its generic equivalents include a warning on their safety labels ... Read More

100 new type 2 diabetes drugs currently in development in U.S.

American biopharmaceutical companies are currently developing 100 type 2 diabetes treatments and another 52 products to treat diabetes-related conditions, according to a new industry report. The report from the Pharmaceutical Research and Manufacturers of America (PhRMA) says that all of the new treatments are either in clinical trials or under review by the U.S. Food and Drug Administration (FDA). The drugs include a new diabetes treatment that enhances glucose-dependent insulin secretions. Type 2 diabetes is a chronic condition that increases the risk for serious health problems including cardiovascular disease, kidney disease, dementia, blindness and amputations due to neuropathy. An estimated ... Read More

Takeda must admit document destruction to jurors in first federal Actos bladder cancer lawsuit

Attorneys for a man suing Takeda Pharmaceutical Co. will be allowed to tell jurors about claims that the company intentionally destroyed files related to bladder cancer risks with its type 2 diabetes drug Actos, U.S. District Judge Rebecca Doherty said. Company officials admitted they could not find files from 46 current and former employees – including two directors – regarding the development, marketing and sale of the drug. Some of those files were deleted from company computers after employees were warned by executives to retain them, the judge said. Takeda is preparing for the first federal court trial over bladder ... Read More

Drug company sees promise in trials of first oral insulin pill

An Israeli drugmaker is doing something no company has ever done before – developing an insulin that can be taken by mouth. Clinical trials using the drug in type 2 diabetic patients are currently underway and early results are promising. Insulin therapy is important for regulating blood sugar levels in both type 1 and type 2 diabetics. Those who require insulin take it by injection –usually from a shot or pump that injects the insulin into the fat under the skin so it can get into the blood. Insulin has not been previously been available in an oral pill because ... Read More