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RSS FeedPosted by Michael Wonder on 20 May 2020
Trump pushing for drug pricing action after Senate lunch
20 May 2020 - President Trump told Republican senators during a meeting on Tuesday that he still wants congressional action ...
Posted by Michael Wonder on 20 May 2020
Global regulators commit to cooperate on observational research in the context of COVID-19
20 May 2020 - Regulators from around the world have agreed three priority areas for cooperation on observational research during ...
Posted by Michael Wonder on 19 May 2020
(COVID-19) update: FDA collaborations promote rigorous analyses of real world data to inform pandemic response
19 May 2020 - Today, the FDA is announcing another step in our effort to harness diverse streams of data to ...
Posted by Michael Wonder on 19 May 2020
FDA appears to soften stance on hydroxychloroquine after Trump says he takes malaria drug
19 May 2020 - The U.S. FDA said Tuesday that taking hydroxychloroquine is “ultimately” a choice between patients and their ...
Posted by Michael Wonder on 18 May 2020
EMA may conditionally authorise remdesivir in the ‘coming days’
18 May 2020 - The EMA's Executive Director Guido Rasi on Monday told a European Parliament committee that the agency ...
Posted by Michael Wonder on 18 May 2020
COVID-19 vaccine frontrunners emerge as rollout debate rages
18 May 2020 - Governments and drug makers are weighing how to roll out coronavirus vaccines, including reserving the first ...
Posted by Michael Wonder on 18 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
18 May 2020 - The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around ...
Posted by Michael Wonder on 18 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #6
15 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 16 May 2020
Independent pharmacies sue major PBM over alleged illegal price discrimination and reimbursement violations
15 May 2020 - The newest litigation against a major pharmacy benefit manager comes from a likely source: its small ...
Posted by Michael Wonder on 15 May 2020
A drug company wagers the U.S. won’t dare charge it with crimes
15 May 2020 - Teva, the world’s largest maker of generic drugs, recently pulled out of settlement talks with the Justice ...
Posted by Michael Wonder on 12 May 2020
Investigators propose different measures for biosimilar equivalence
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...
Posted by Michael Wonder on 12 May 2020
COVID-19 update: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19
11 May 2020 - Today, the U.S. FDA took important actions to help accelerate the development of prevention and treatment options ...
Posted by Michael Wonder on 12 May 2020
FDA's drug approval system is more open than Australia's
11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies. ...
Posted by Michael Wonder on 11 May 2020
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
11 May 2020 - EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir ...
Posted by Michael Wonder on 08 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #5
8 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...