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RSS FeedPosted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 15 Sep 2021
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. ...
Posted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 14 Sep 2021
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. ...
Posted by Michael Wonder on 14 Sep 2021
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 ...
Posted by Michael Wonder on 14 Sep 2021
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 ...
Posted by Michael Wonder on 14 Sep 2021
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 ...
Posted by Michael Wonder on 13 Sep 2021
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 ...
Posted by Michael Wonder on 13 Sep 2021
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 ...
Posted by Michael Wonder on 12 Sep 2021
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 ...
Posted by Michael Wonder on 11 Sep 2021
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. ...
Posted by Michael Wonder on 10 Sep 2021
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 ...
Posted by Michael Wonder on 09 Sep 2021
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 ...
Posted by Michael Wonder on 09 Sep 2021
Biden Administration unveils plan to cut prescription drug prices
9 September 2021 - The Department of Health and Human Services plan supports legislation to empower the government to negotiate Medicare ...
Posted by Michael Wonder on 09 Sep 2021
Health funds reject claims hospitals hit by prostheses reforms
9 September 2021 - Health insurers say private hospital operators will not be left out of pocket, rejecting claims they ...