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    Regulatory Recon: Juno Halts Trial After 3 Deaths Theranos CEO Banned From Running Lab for 2 Years (8 July 2016)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter. In Focus: US Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths ( Forbes ) ( NY Times ) ( WSJ -$) ( Xconomy ) ( Endpoints ) ( Stat ) ( Fierce ) ( TheStreet ) ( Reuters ) ( Scrip -$) ( In the Pipeline ) ( Press ) FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children...
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    FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015

    In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday. The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than $5,000 consulting fee from AstraZeneca in 2015. In 2014, when he ...
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    New Report Calls on FDA to Clarify Use of Real-World Evidence

    As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments. The Bipartisan Policy Center’s 32-page repo...
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    Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA

    The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week. While Califf said his first priority as commissioner is to strengthen FDA's workforce, that stronger workforce will be critical to achieving FDA's goals in specific program areas s...
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    Senate Confirms Califf as Next FDA Commissioner

    The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA). Califf's path to confirmation was made clear after a procedural vote Monday evening, when senators voted 80 to 6 to move the nomination to a vote. In September, President Barack Obama nominated Califf to replace Margaret Hamburg, who resigned in March after leading FDA for six years and was replaced in th...
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    Updated: Califf Headed for Confirmation as Next FDA Commissioner

    Only six senators voted against Robert Califf in a procedural vote late Monday setting up a final vote for his appointment as the next commissioner of the US Food and Drug Administration. On Tuesday, a handful of senators continued to criticize FDA over their opioid approvals, though these criticisms are not expected to halt Califf's confirmation. The positive vote on Monday for the former Duke University cardiologist and clinical trials expert also came after an hour of...
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    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
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    Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

    [Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin]. Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation. “Like many Americans, I was baffled by th...
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    Senate HELP Committee Votes in Favor of Califf for FDA Commissioner

    The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner. HELP Committee Chairman Lamar Alexander (R-TN) called Califf “the right man to lead the FDA,” as others offered their support. Sen. Lisa Murkowski (R-AK), who said back in November she would put a hold on Califf’s nomination, said at the hearing that she “g...
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    Califf Vows Not to Lower or Remove FDA Regulations

    President Barack Obama’s US Food and Drug Administration (FDA) commissioner nominee Robert Califf, who faces a Senate committee vote Tuesday, told legislators in written comments that he does not support the lowering or removal of regulations at FDA, though he previously said they were a barrier to innovation. In response to questions from Sen. Lamar Alexander (R-TN) last week, following a November hearing in which senators were largely supportive of the former directo...
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    EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee

    The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals. The trial , which compared the anti-clotting drug Xarelto (rivaroxaban) for patients with irregular heartbeat with warfarin, used an INR (International Normalized Ratio) device ...
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    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...