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Merck 101 articles

FDA places clinical hold on Keytruda trials

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The Food and Drug Administration (FDA) has placed a clinical hold on three trials involving the cancer drug Keytruda (pembrolizumab) in patients with the blood cancer multiple myeloma, raising concerns about the number of patients who have died after receiving the drug. The announcement comes just weeks after a review by the Data Monitoring Committee during which more deaths were observed in patients who had been treated with Keytruda, which led to the FDA ordering a hold on new enrollment in two of the three studies. Merck was testing the anti-PD-1 therapy in one trial with Keytruda in combination with Pomalyst ... Read More

Keytruda clinical trial halted after patient deaths

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Drug company Merck has halted enrollment for new patients in two of its late-stage combination studies involving its blockbuster cancer drug Keytruda after the monitoring committee raised concerns about patient deaths in studies involving multiple myeloma, according to BioPharma Dive. Patients currently participating in the trial will continue to be treated while Merck sets out to evaluate why the deaths occurred. In one trial Keytruda in combination with Pomalyst and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma who have undergone at least two lines of prior treatment was compared with Pomalyst and low-dose dexamethasone only in the ... Read More

Dismissed Fosamax bone fracture lawsuits revived by appeals court

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About 5,000 lawsuits alleging femur fractures caused by Merck’s osteoporosis drug Fosamax that had been dismissed in federal and state courts were given new life when the U.S. Court of Appeals for the Third Circuit overturned the dismissal. The appeals court found that the District Court misapplied the U.S. Supreme Court’s 2009 ruling in Wyeth v. Levine, during which the Supreme Court held that state-law failure-to-warn claims are preempted when there is evidence that the Food and Drug Administration (FDA) would not have approved a warning label that those suing the drug company claim was necessary. In June 2014, U.S. ... Read More

Male pattern baldness meds allegedly taken by Trump linked to sexual side effects

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President Donald Trump takes a medication to treat male pattern baldness, his personal physician revealed, which is at the heart of a class action lawsuit over reported sexual side effects. The drug in question is Propecia, known chemically as finasteride and manufactured by Merck. Finasteride, under the brand name Proscar, was approved by the Food and Drug Administration (FDA) in 1992 to treat symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate. In 1997, the FDA approved finasteride, under the brand name Propecia, to include treatment for male pattern baldness. Both drugs are for men only. In ... Read More

New diabetes drug tested as an add-on in triple therapy

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Merck and Pfizer are teaming up on a new type 2 diabetes treatment and if clinical trials continue to show promise, they hope to apply for Food and Drug Administration (FDA) approval by the end of the year. The experimental drug, ertugliflozin is in a class of type 2 diabetes drugs called sodium glucose cotransporter 2 (SGLT2) inhibitors, which also includes the brand names Invokana, Invokamet and Jardiance. SGLT2 inhibitors work to lower blood sugar levels by blocking the reabsorption of glucose in the kidneys, allowing more sugar to be excreted through the urine. Ertugliflozin improved glycemic control in type ... Read More

Merck gives up on experimental osteoporosis drug due to safety concerns

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Merck’s experimental osteoporosis drug odanacatib showed that it was effective at preventing bone fractures, but put users at risk of atrial fibrillation and stroke. As a result, Merck said that the risks of the drug outweighed the benefits and thus they were officially giving up on the development of odanacatib. Atrial fibrillation is a quivering or irregular heartbeat that can lead to blood clots, strokes, heart failure, and other heart-related conditions. Two years ago, Merck announced it was delaying a filing with the Food and Drug Administration (FDA) after Phase III results raised cardiovascular safety concerns. The news was a blow ... Read More

FDA warns of dosing errors with antifungal drug Noxafil

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Reports of hospitalizations and a patient death related to dosing errors with the antifungal medication Noxafil (posaconazole) have prompted the Food and Drug Administration (FDA) to issue a Drug Safety Communication cautioning health care providers that there has been confusion with differences in dosing regimens between two oral formulations of the drug Noxafil. Noxafil is used to treat or prevent fungal infections such as Aspergillus and Candida, especially in people with weakened immune systems such as those undergoing chemotherapy, stem cell transplantation and those with HIV infections. It is also used to treat a fungal infection called thrush caused by ... Read More

Merck accused of FLSA violations; class action filed by plant employees

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Merck & Co. Inc., the pharmaceutical giant responsible for drugs like Vioxx and Gardasil, is now the target of a proposed class and Fair Labor Standards Act (FLSA) collective action filed in New Jersey federal court. The suit claims the Merck employees were forced to labor at least 45 minutes prior to their normal shift daily without compensation. The 26 employees worked full time in the Rahway, N.J., “pilot plant” as research chemical operators (RCOs), some having been employed as early as 1995. Upon bringing the unpaid compensation issue up to the company, the complaint alleges Merck threatened their jobs and ... Read More

Four Dangerous Diabetes Drugs

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Type 2 diabetes is a growing epidemic around the world with an estimated one in 10 adults predicted to be suffering from the disease by 2030, according to the International Diabetes Foundation. Diabetes increases the risk for serious health complications including heart disease, kidney disease, cancer, blindness, dementia and amputations from neuropathy. Many diabetics require medication to help control blood sugar levels. There are dozens of diabetes treatments on the market and more being developed. But these drugs come at a risk. Here are five type 2 diabetes drugs that carry dangerous side effects: Invokana/Invokamet – Known chemically as canagliflozin, Invokana ... Read More

Whistleblowers accuse Merck of withholding, distorting mumps vaccine data

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Two former Merck virologists who filed a whistleblower lawsuit against the pharmaceutical company alleging it falsified data so the U.S. government would buy its mumps vaccine are now also accusing the drug giant of dodging questions about the vaccine’s effectiveness. In a June 1 letter, Stephen A. Krahling and Joan A. Wlochowski, who filed the whistleblower suit against Merck & Co. under the federal False Claims Act, asked Pennsylvania federal judge Lynne A. Sitarski to force Merck to answer questions about the effectiveness of its mumps vaccine, saying the company is “hiding behind a facade of confusion and obfuscation” on ... Read More