Raising the bar for using surrogate outcomes in drug regulation and health technology assessment

16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...

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Drug makers see disaster in Medicare negotiating prices. Don’t listen to them.

16 September 2021 - The pharmaceutical industry, bizarrely, told the American people this week that allowing Medicare to negotiate drug ...

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FDA, EMA launch complex generic, hybrid product advice pilot

15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...

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Drug prices measure blocked in House Committee as Democrats splinter

15 September 2021 - Provision of $3.5 trillion budget package would allow Medicare to negotiate over the cost of prescriptions. ...

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Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs

14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...

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EMA study reveals need for RWE framework, submission structure

14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...

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Moderate House Democrats threaten drug pricing bill in House panel

14 September 2021 - Three moderate House Democrats announced that they would vote against their party's legislation to lower drug ...

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Biden drug pricing plan seeks to balance access and innovation

13 September 2021 - On Thursday 9 September, Health and Human Services Secretary Xavier Becerra publicly released the Biden Administration’s ...

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A court decision on “skinny labeling” another challenge for less expensive drugs

13 September 2021 - Brand name drugs, such as apixaban (Eliquis) and lenalidomide (Revlimid), account for approximately 80% of US drug ...

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Joint statement of support for an Australian Patent Box

13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...

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1 October 2021 price disclosure confirmed prices

13 September 2021 - Confirmed 1 October 2021 prices resulting from the 2021 October cycle of price disclosure have now been ...

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Biden Administration’s prescription drug pricing plan promotes incremental change, not overhaul of system

12 September 2021 - On Thursday, September 9th, the White House released a long awaited plan to reduce prescription drug ...

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MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines

9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme. ...

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Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...

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Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates

9 September 2021 - Senate lawmakers are actively considering pegging the prices Medicare pays for drugs to those drug makers ...

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