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Drug 100 articles

New Program Documents Doctors Receiving Payment from Drug Companies

A new aspect of the Affordable Care Act has been released, allowing the public to see records of payment between drug companies and doctors. This program, called Open Payments, is aimed at bringing more transparency to our nation’s health care system. The government’s data shows that drug and device companies made 4.4 million payments totaling $3.5 billion in a five-month period at the end of 2013. This money paid for speeches, research grants, travel, and other things that involved 546,000 health care professionals and 1,360 teaching hospitals. The Centers for Medicare & Medicaid Services (CMS) collects information from manufacturers of drugs and devices about ... Read More

Medical device and drug manufacturers among those critical of FDA Guidance Policy

The U.S. Food and Drug Administration (FDA) has been petitioned to reform its guidance process used by drug and medical device makers in order to make the system faster and create a more responsive process. According to the FDA, guidance documents represent the Agency’s current thinking on a particular subject. Critics are accusing the FDA of becoming “sluggish and secretive” when dealing with the guidance process, but FDA attorneys are claiming that the agency is open to reform. Two years ago, Bradley Merrill Thompson, an attorney at Epstein Becker Green, filed a 400-page citizen petition concerning these issues, hoping for a response ... Read More

Controversial analysis suggests Actos may help protect users from dementia

The type 2 diabetes drug Actos could help ward off dementia, a new analysis has found. However, researcher say more analysis is needed as well as adverse side effects addressed before the medication can be recommended as a preventative measure. The analysis involved data from Germany’s biggest public health insurer, which included about 146,000 patients aged 60 or older. The patients were tracked from 2004 to 2010, during which time about 14,000 of them developed dementia. When prescriptions for Actos were factored into the analysis, researchers found that patients taking Actos had about a 6 percent decline in the likelihood ... Read More

Once-weekly injectable type 2 diabetes treatment just as effective as Victoza

Dulaglutide, an experimental once-weekly injectable treatment for type 2 diabetes, works just as well as the daily injectable drug Victoza (liraglutide), according to a new data from a clinical trial pitting the two diabetes drugs against each other. Even though dulaglutide did not perform better than Victoza, the results are considered a huge success since injectable medications are generally not favored by patients. Previous clinical trials have compared dulaglutide with the insulin drug metformin, and newer type 2 medications Byetta and Januvia, the latter of which is a leader in diabetes treatments with sales topping $4 billion a year. Dulaglutide ... 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

European advisors give nod to GSK’s new type 2 diabetes treatment

A medical products advisory committee for the European Medicines Agency (EMA) has recommended approval for the marketing of GlaxoSmithKline’s type 2 diabetes treatment albiglutide. The experimental treatment would be marketed under the name Eperzan. If approved, Europe would be the only country in the world to offer the new drug. The EMA is not required to follow the recommendation of its advisory committee, but it typically does. Albiglutide is in a newer class of type 2 diabetes drugs known as glucagon-peptide-1 (GLP-1) receptor agonists. Other drugs in this class include the brand name drugs Byetta and Victoza. These currently marketed ... Read More

FDA rejects novel drug for multiple sclerosis, cites safety concerns

The Food and Drug Administration (FDA) has rejected Sanofi’s Genzyme unit’s bid for the multiple sclerosis (MS) drug alemtuzumab (Lemtrada), citing inadequate data and concerns about life threatening side effects. The drug company says it disagrees with the FDA’s decision and will appeal. MS is a debilitating autoimmune disease that affects the central nervous system, causing symptoms such as coordination problems and spasticity. Alemtuzumab is a novel treatment designed to down-regulate the inflammatory activity in MS. It is administered as an initial five-day course of infusions followed by a second three-day course a year later. The drug was pitted against beta-interferon, ... Read More

FDA panel recommends approval of new type 2 diabetes drug dapagliflozin

A Food and Drug Administration (FDA) advisory panel has voted to recommend the approval of a new type of type 2 diabetes medication two years after it was rejected by regulators based on concerns that it could increase the risk of cancer and cardiovascular events. Dapagliflozin, from Bristol-Myers Squibb and AstraZeneca, is a once-daily pill in a new class of diabetes medications known as SGLT-2 inhibitors. The FDA rejected the drug in January 2012, saying it needed more data to asses breast and bladder cancer concerns as well as heart risks. The drug companies resubmitted the application with several new ... Read More

Makers of new diabetes drug hope more data will help drug win FDA approval

Blood sugar levels were improved, body weight was reduced, and blood pressure was lowered in patients who were given a new type 2 diabetes drug, according to the drug’s makers, Bristol-Myers Squibb and AstraZeneca. The treatment, known as dapagliflozin, was pitted against a placebo in clinical trials in patients with type 2 diabetes who were also taking a combination of metformin plus sulfonylurea. Dapagliflozin is a once daily pill that was approved in the European Union under the brand name Forxiga last November. It is also sold in Australia, Brazil, Mexico and New Zealand. Dapagliflozin works by removing excess blood ... Read More

Certain fruits can help protect against type 2 diabetes

Consuming certain fruits can help protect against type 2 diabetes, according to a large cohort study published in the British Medical Journal. The study focused on individual fruit consumption among more than 187,000 people who at the start of the study did not have diabetes, cardiovascular disease or cancer. The participants were given food frequency questionnaires every four years to analyze diet. The surveys specifically asked how often the people ate 10 different fruits including grapes or raisins; peaches, plums or apricots; prunes; bananas; cantaloupe; apples or pears; oranges; grapefruit; strawberries; and blueberries. They were also questioned about their intake ... Read More