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Osteoporosis drug rejected over heart risks

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The Food and Drug Administration (FDA) has rejected the Biologics License Application (BLA) of Amgen and UCB’s osteoporosis drug Evenity, raising concerns about serious cardiac side effects seen in late-stage clinical trials, according to Genetic Engineering & Biotechnology News. Evenity, which contains the acrive ingredient romosozumb, was being tested as an osteoporosis treatment in postmenopausal women. The drug companies’ original submission to the FDA included data from a Phase III trial. The FDA says that it would like to see efficacy and safety data from other studies in the company’s resubmission of the drug, including a Phase II clinical trial ... Read More

Doctor Faces False Claims Act charges of Medicaid Fraud

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Connecticut initiated a False Claims Act lawsuit against a Norwalk doctor and his practice, alleging they defrauded the state’s Medicaid program out of thousands of dollars by billing it for services that were never performed. “The audacity of the alleged fraudulent conduct in this case is astounding,” said Attorney General George Jepsen. “In one case, this provider billed Medicaid for at least 500 visits to a particular patient that never happened, receiving $80,000 in taxpayer dollars for services never rendered, and at the same time, sought to receive Medicaid benefits himself. “ The state’s False Claims Act lawsuit alleges that ... Read More

Supplement maker slapped with warning

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Significant violations of Current Good Manufacturing Practice (CGMP) regulations were identified during an inspection of dietary supplement maker Black Seed Herb Inc.’s facility in Liberty, New York, resulting in a Food and Drug Administration (FDA) warning letter. “These violations cause your dietary supplement products, including but not limited to Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, Black Seed w/ Olive Leaf/Garlic Capsules, Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil, to ... Read More

Same equipment used to make Car polish, mouthwash

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During a rather unappetizing inspection of Wisconsin-based ChemRite CoPac Inc.’s facility, the Food and Drug Administration (FDA) found concerning manufacturing practices such as using the same equipment to make its over-the-counter and other oral products as it used to make industrial car polishes and other nonpharmaceutical products. The car polishes are paraffin-based and have warning labels that state “harmful or fatal if swallowed” and “keep out of reach of children.” “The ingredients in your non-pharmaceutical products are extremely difficult to remove from manufacturing equipment, and could contaminate the drug products that you manufacture on shared equipment, such as the various ... Read More

Lawsuit over Merck’s shingles vaccine

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A group of consumers across the country claim they have suffered a persistent strain of shingles after receiving Merck & Co.’s shingles vaccine Zostavax, and have launched a product liability action against the drug maker in New Jersey state court for not adequately warning about the risks associated with the vaccine, Law360 reported. Some consumers claim to have developed a condition called postherpetic neuralgia, resulting in nerve damage and pain. One victim says her symptoms were accompanied by scarring. The lawsuit was filed July 11 in Middlesex County Superior Court by 18 plaintiffs from Louisiana, South Carolina, Tennessee, Kentucky, Mississippi, ... Read More

ED drug in coffee prompts recall

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Bestherbs Coffee LLC is recalling its New Kopi Jantan Tradisional Natural Herbs Coffee because the product packs far more than caffeine. A laboratory analysis conducted by the Food and Drug Administration (FDA) found that the coffee contains hidden desmethyl carbodenafil, an ingredient structurally similar to sildenafil, the active ingredient in the erectile dysfunction drug Viagra. New Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk. Both undeclared ED drugs and milk in this product pose health risks to some consumers. Desmethyl carbodenafil, like Viagra, may interact with nitrates found in some prescription drugs, like nitroglycerin, and may lower blood ... Read More

CSX To Appeal Jury Verdict For Camerawoman Killed

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CSX Railroad intends to appeal a jury verdict ordering it to pay $3.9 million to the family of a woman killed on the set of “Midnight Rider,” a movie about the life of singer Gregg Allman, after it had just started shooting in southeastern Georgia. Sarah Jones, a 27-year-old camera assistant, was killed when she was hit by a CSX train Feb. 20, 2014, on a railroad trestle spanning the Altamaha River in Doctortown, Georgia. Six other members of the film crew were injured by flying debris and shrapnel. Richard and Elizabeth Jones, Sarah’s parents, sued CSX and 11 others ... Read More

‘Is there something wrong with Invokana?’

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“Is there something wrong with Invokana?” The Motley Fool posed this question as part of a roundup of elements leading up to Johnson & Johnson’s quarterly report, which the media source says “often sets the tone for the pharmaceutical industry.” Johnson & Johnson is expected to produce $18.97 billion in sales – a growth of 2.6 percent over last year’s quarter. But, The Motley Fool says, “there is so much more to pay attention to than just a single sales and profit-per-share figure.” This includes the status of Johnson & Johnson’s top selling diabetes drug Invokana, which is manufactured by subsidiary ... Read More

Egg donation center slapped with FDA warning

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The Food and Drug Administration (FDA) has cracked down on a fertility clinic for not properly screening its egg donors for exposure to Zika, HIV, syphilis and other diseases. The agency issued Illinois-based Center for Reproductive Health a warning letter for deeming at least four women eligible to be egg donors before receiving the results of communicable disease tests. The FDA also found other concerning violations such as donor records with multiple or altered assessment dates. Medical history forms also had confusing dates and didn’t include questions related to conditions such as West Nile virus and syphilis or behaviors that ... Read More

Battery Fire Risk Prompts Latest Honda Recall

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A defective battery sensor at risk of catching fire is forcing Honda to recall approximately 2.1 million Honda Accord vehicles worldwide, Reuters reports. The vehicles are from the 2013-2016 model years and include 1.15 million vehicles in the U.S. where 3,972 warranty claims relating to the issue have already been submitted to the auto manufacturer. The sensor on a 12-volt battery may not be sealed adequately, which allows moisture to breach the seal. The trapped moisture may attract other material, such as road salt, over time that causes the sensor to rust and ultimately short circuit. At least five engine ... Read More