Accelerating the shift toward person-generated real world evidence

19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...

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Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed

20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...

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FDA approves first oral GLP-1 treatment for type 2 diabetes

20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult ...

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SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury

19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...

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How an 'International Price Index' might help reduce drug prices

19 September 2019 - In gridlocked Washington, both Democrats and Republicans have signalled there's potential for a deal when it ...

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FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program

19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...

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McConnell warns Pelosi's drug pricing plan is DOA

19 September 2019 - Senate Republicans are warning Speaker Nancy Pelosi that her much-anticipated drug pricing plan is dead and ...

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Pelosi’s drug plan would let U.S. negotiate prices of 250 medications

19 September 2019 - Speaker Nancy Pelosi on Thursday released her long-awaited plan to curb soaring prices of prescription drugs, ...

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Why prescription drugs cost so much more in America

19 September 2019 - The US spends more per capita on medication than anywhere else in the world. It’s a key ...

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FDA grants fast track designation for SPI-1005 in the treatment of Meniere's disease

18 September 2019 - Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request ...

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Medicare Part D rebates ‘substantially’ reduced drug spending, but not enough to offset price hikes

18 September 2019 - As controversy continues over prescription drug pricing, a new study finds that Medicare Part D spent ...

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Health insurance that doesn’t cover the bills has flooded the market under Trump

18 September 2019 - The administration’s moves to weaken the Affordable Care Act have taken hold, and companies are cashing in. ...

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FDA issues final guidance to address ‘gaming’ by the use of citizen petitions

18 September 2019 - Today the U.S. FDA issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject ...

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FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program

18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...

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Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes

12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...

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