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Regulatory
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U.K. bans certain exports to preserve drug stockpiles in case of no-deal Brexit

Oct. 7, 2019
By Nuala Moran
LONDON – The U.K. government has placed an immediate ban on the export of certain drugs in a bid to prevent wholesalers taking advantage of the fall in the value of the pound against the euro by selling off U.K. stockpiles that have been built up to protect against an interruption in supplies in event of a no-deal Brexit.
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FDA approves Descovy for HIV-1 PrEP

Oct. 4, 2019

FDA approves Entresto for pediatric heart failure

Oct. 4, 2019

Trump promises quicker Medicare coverage for breakthrough technologies

Oct. 4, 2019
By Mari Serebrov
Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.
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Advamed urges CMS to form Medicare advisory panel for digital health

Oct. 3, 2019
By Mark McCarty
Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."
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It's not just about pricing as drug-related bills continue to pile up in Congress

Oct. 2, 2019
By Mari Serebrov
While the U.S. House and Senate push forward with controversial legislative packages aimed at making prescription drugs more affordable for Americans, other bills that would impact the biopharma sector are making their own way through Congress, being absorbed into the larger pricing packages or getting tacked on to unrelated legislation.
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China three-year plan aims to put patient access to cancer drugs on par with other markets

Oct. 2, 2019
By Elise Mak
SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.
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FDA approves Invokana for use in patients with type 2 diabetes and diabetic kidney disease

Oct. 1, 2019

FDA approves Rituxan for pediatric granulomatosis with polyangiitis and microscopic polyangiitis

Sep. 30, 2019

FDA sorts out regulated, non-regulated decision support apps in new draft

Sep. 30, 2019
By Mark McCarty
The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.
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