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Current Events
Monday, September 21, 2015
Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection.
The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars. Read more.
Friday, September 18, 2015
The Food and Drug Administration warned doctors that bronchoscopes may transmit infections among patients when inadequately cleaned, the latest alert by the regulator about the risk of reusable medical scopes. The agency recorded 109 reports of infections or contamination related to bronchoscopes in the past five years, including 50 in 2014 alone, according to its safety notice. "A small number" of the incidents showed that the devices remained contaminated even when manufacturers’ cleaning instructions were followed, the agency said. Read More
Friday, September 18, 2015
General Motors Co. will pay $900 million to settle a criminal probe by the U.S. Justice Department over the ignition switch flaw that has bogged down Chief Executive Officer Mary Barra in recalls and investigations since almost the start of her tenure. The settlement is part of a deferred-prosecution agreement under which the U.S. will monitor some of the automaker’s safety policies and the company must cooperate with the government, federal prosecutors in New York said Thursday. GM was charged with conspiracy and wire fraud, claims that will be dismissed in three years if GM complies with the accord. Read More
Friday, September 18, 2015
For the first time, a widely used modern diabetes drug has been shown to reduce deaths from cardiovascular disease, a long-sought goal of treatment, researchers announced on Thursday.
In a clinical trial, the drug — Jardiance, sold jointly by Eli Lilly and Boehringer Ingelheim — reduced the overall risk of having a heart attack or stroke, or of dying from cardiovascular causes, by 14 percent. Looking only at cardiovascular deaths, the reduction was 38 percent. Read More
Friday, September 18, 2015
As the number of deaths linked to defective cars made by General Motors has steadily risen to 124, victims’ families have waited for the answer to a burning question: How will federal prosecutors hold the automaker accountable for its decade-long failure to disclose the defect? On Thursday, they got their answer, and many were disappointed. Read More
Wednesday, September 16, 2015
WASHINGTON — The Food and Drug Administration halted the sale of four types of R. J. Reynolds cigarettes on Tuesday, saying the company failed to prove that they were not more harmful than products already on the market. The agency ordered retailers who sell any of the cigarettes to stop immediately and to dispose of them within 30 days or face financial penalties or criminal prosecution. Read More
Wednesday, September 16, 2015
(Reuters) - XenoPort Inc's psoriasis drug showed high rates of gastrointestinal-related side effects, overshadowing its success in a mid-stage study.
The company's shares, which rose as much as 19 percent premarket, fell sharply in regular trading after the company said on a conference call that a third of its patients in the study dropped out due to the side effects.
During the trial of the drug, XP23829, in patients suffering from the chronic skin disease, adverse events related to diarrhea were 22-40 percent in the drug group, compared with 15 percent in the placebo group, the company said.
Read More
Wednesday, September 16, 2015
The cucumber Salmonella outbreak has grown to include 418 illnesses in 31 states. At least 91 people have been hospitalized and two have died, according to the Centers for Disease Control and Prevention (CDC).
The contaminated cucumbers have been recalled from retail locations. But before September 3, these dark green cucumbers, called “slicer” or “American” cucumbers, which are about 7 to 10 inches long, and about 1.75 to 2.5 inches in diameter, were sold in grocery stores in bulk bins with no individual packaging, labeling, or wrapping. Restaurants also served them. Read More
Wednesday, September 16, 2015
Amid rising concerns about superbug outbreaks linked to contaminated medical scopes, federal regulators are demanding more rigorous testing of the machines used to clean the devices — and cracking down on manufacturers that don’t meet government standards.
The steps are part of a Food and Drug Administration effort to ensure the effectiveness of Automated Endoscope Reprocessors, or AERs, which are akin to high-tech dishwashers used to clean medical scopes between uses. The measures focus specifically on checking the reprocessors’ efficacy in cleaning and disinfecting duodenoscopes, which have been found in some cases to spread antibiotic-resistant bacteria from patient to patient. Read More
Tuesday, September 15, 2015
Some of Wall Street’s biggest financial institutions -- including Goldman Sachs Group Inc., JPMorgan Chase & Co., Citigroup Inc. and HSBC Holdings Plc -- have agreed to a $1.87 billion settlement to resolve allegations they conspired to limit competition in the lucrative credit-default swaps market. The banks reached an agreement in principle with a group of investors that includes the Los Angeles County Employees Retirement Association, Daniel Brockett, a lawyer for the group, told a judge in Manhattan federal court on Friday. The sides need seven to 10 more days to iron out some details, Brockett said. Read More
Tuesday, September 15, 2015
Ten major automakers pledged to equip all new cars with automatic emergency braking (AEB) and forward-collision warning systems over the next few years, according to a recent announcement from federal regulators. Though there’s still no official timeline for the rollout, Audi, BMW, Toyota, Tesla, Volvo, Ford, General Motors, Mazda, Mercedes-Benz, and Volkswagen agreed to make collision-detecting sensors standard features in cars and trucks. It’s an effort to make crash-preventing technology more widely available to consumers. AEB systems are designed to diminish accidents – especially rear-end collisions – where drivers fail to apply the brakes in time to avoid crashes. Read More
Alan W. Clark & Associates represent clients throughout Long Island and the New York Metropolitan Area, including New York County, Richmond County, Kings County, Queens County, Bronx County, Nassau County, Suffolk County, and Westchester County.
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