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Merck 89 articles

Merck company Organon to pay several states $31 million to settle Medicaid fraud allegations

whistleblower

Following an investigation into possible Medicaid fraud, Drug maker Organon USA Inc., a subsidiary of pharmaceutical giant Merck, has agreed to pay $31 million to settle allegations by several U.S. states that it overcharged their Medicaid programs for the anti-depressant Remeron and Remeron SolTab. The states claimed that Organon encouraged pharmacies to offer Remeron to their nursing home clients by providing the drug at a discount, which gave Organon a competitive edge against other drug manufacturers. Organon then reported the drug’s full cost when it sought reimbursements from the Medicaid programs in multiple states, the plaintiffs alleged. Washington D.C. and ... Read More

Merck’s once-weekly diabetes drug as effective as Januvia

januvia - sitagliptin

Merck’s new, once-weekly experimental type 2 diabetes treatment was found in recent clinical trials to have a similar safety and efficacy profile compared to Merck’s sitagliptin, marketed under the brand name Januvia. The study involving the new omarigliptin randomly assigned participants with type 2 diabetes into one of three groups – once-weekly omarigliptin 25 mg; once-daily Januvia 50 mg; or placebo. A mixed-meal tolerance test was performed the day before the study drugs were administered and again at 24 weeks, 1 day after the last dose of Januvia, or 7 days after the last dose of omargliptin. Researchers found that ... Read More

British Columbia refuses to cover some type 2 diabetes drugs

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The British Columbia Medical Beneficiary and Pharmaceutical Services Division has delisted all sitagliptin drugs, including Januvia and Janumet, from its Pharmacare Benefits Program and will adjust its coverage of all other diabetes drugs in the class by February 2015. The agencies gave no reason for this action but experts speculate that it may be because sitagliptin has been linked to serious pancreatic side effects. Merck, maker of Januvia and Janumet, is fighting the action, saying the move limits therapeutic options for patients. Januvia works by enhancing the body’s own ability to control blood sugar levels by increasing insulin production when ... Read More

Merck reaches $100 million settlement in NuvaRing side effects lawsuits

NuvaRing - WIKI

A $100 million settlement involving life threatening side effects from Merck’s NuvaRing birth control device will stand now that a vast majority of claimants have agreed to the terms of the settlement. The settlement was approved by U.S. District Judge Rodney W. Sippel of St. Louis in February; however, Merck had the opportunity to abandon the deal if it did not get at least 95 percent of the claimants to sign off on the terms. About 3,800 people will share in the settlement. NuvaRing was approved as a contraceptive device in 2002 by the Food and Drug Administration (FDA). It ... Read More

FDA panel votes against approval of Singulair Allergy for OTC use

Singulair

A Food and Drug Administration (FDA) advisory panel is recommending that the agency not approve Merck’s Singulair Allergy drug for over-the-counter treatment for allergic rhinitis because of safety concerns. Singulair, which contains the active ingredient montelukast, was approved in 1998 for the treatment of asthma in both children and adults. In 2002 and 2005, the indication was expanded to include the treatment for seasonal allergic rhinitis and perennial allergic rhinitis, respectively. In 2007, it was approved for exercise-induced bronchoconstriction. Merck was seeking OTC approval of Singulair Allergy for the treatment of allergy symptoms only in adults 18 years and older, ... Read More

FDA panel recommends approval of new blood thinner despite serious side effects

blood cells

A Food and Drug Administration (FDA) advisory panel stunned analysts last week by voting to recommend the approval of an experimental new blood thinner from Merck despite concerns about serious side effects such as internal bleeding. The drug, vorapaxar, is designed to help prevent blood clots in patients with a history of heart attacks. Clinical trials on the drug were hit with rough patches. One large study was shut down and enrollment of another halted after data showed a significant increased risk of internal bleeding, including dangerous bleeding inside the skull. However, when the drug was used in patients who had ... Read More

Pharmaceutical investors should look for alternatives to statin medications

lipitor

Investors wanting to win big in the pharmaceutical market should look to new kinds of LDL, or “bad” cholesterol, treatments instead of putting money toward new or existing cholesterol-lowering statin drugs, Motley Fool advises. Drug companies such as Pfizer, AstraZeneca and Merck have scored well in the past decade with blockbuster statins such as Lipitor, Crestor, and Zocor, respectively. In its peak year (2006), Lipitor earned in $13.7 billion in sales. Six years later the company reports $3.9 billion in sales. Crestor cashed in $6.3 billion in 2012, and Zocor earned a mere $244 million last year, down from $5.4 ... Read More

Januvia sales may be threatened by pancreatitis, pancreatic cancer risk

januvia - sitagliptin

Drug maker Merck is putting most of its earnings “eggs” in one basket – Januvia, a type 2 diabetes drug – after its top-selling Singular went off patent protection and generic competition moved in. However analysts are unsure Januvia can fill the $1 billion Singular has left behind. Januvia is in a class of type 2 diabetes medications known as DPP-4 drugs. It works by inhibiting the action of the DDP-4 enzyme. It is designed to reduce blood sugar levels in patients with type 2 diabetes. The drug goes head-to-head with Onglyza, which got off to a slow start but ... Read More

Generic Fosamax failed to warn that use could result in rare femur fracture

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Federal law does not stand in the way of a product liability lawsuit alleging the makers of a generic version of the osteoporosis drug Fosamax failed to update its warning label to conform with a revised label on the brand-name drug, the California Court of Appeals ruled. The plaintiff alleged that she suffered a fracture in her thigh bone, or femur, in April 2011 which was caused by prolonged use of Fosamax or its generic equivalent. The lawsuit alleged that Teva Pharmaceutical, makers of a generic version of Fosamax, is liable because it failed to update the warning labels on ... Read More

FDA to review new type 2 diabetes treatment

diabetes_illus250x03

The Food and Drug Administration (FDA) has started a review of Sanofi’s new once-daily type 2 diabetes drug lixisenatide. The drug was approved last month by European Union regulators, and will be marketed as Lyxumia. Sanofi has not yet selected a U.S. brand name for lixisenatide. Lixisenatide works by increasing the body’s insulin production. It is in a class of drugs known as GLP-1 agonists, which also includes Bristol-Myers Squibb’s Byetta and Bydureon, and Merck’s Januvia. A recent study published in the JAMA Internal Medicine found that patients using GLP-1 drugs may be twice as likely to develop pancreatitis than ... Read More