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RSS FeedPosted by Michael Wonder on 15 Jul 2021
Pharma companies fined after 10,000% price rise for life saving drug
15 July 2021 - UK watchdog imposes £260 million in penalties for increases in costs of hydrocortisone tablets. ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief tells reporter ‘move on’ when pressed on Biogen Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Dr. Janet Woodcock pushed back against questions from a journalist about the approval of ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...
Posted by Michael Wonder on 13 Jul 2021
Biden in standoff with Democratic senators over who should lead FDA
13 July 2021 - Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 13 Jul 2021
Biden wants a drug pricing plan in 45 days. Who’s going to write it?
13 July 2021 - Medicare announced it’s opening a so-called National Coverage Determination for Biogen’s divisive new Alzheimer’s drug, Aduhelm. ...
Posted by Michael Wonder on 13 Jul 2021
Powerful House Democrats demand documents from Biogen about co-ordination with FDA on new Alzheimer’s drug
12 July 2021 - Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and ...
Posted by Michael Wonder on 12 Jul 2021
In a sweeping executive order, Biden endorses importing drugs from Canada and orders a bigger drug pricing plan by late August
9 July 2021 - President Biden on Friday will take aim at the pharmaceutical industry by ordering his administration to ...
Posted by Michael Wonder on 12 Jul 2021
Teplizumab awarded Innovation Passport in the United Kingdom for the delay of onset of clinical type 1 diabetes in at risk individuals
12 July 2021 - Designation is the first step in a new MHRA initiative to accelerate the development and access to ...
Posted by Michael Wonder on 12 Jul 2021
FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
9 July 2021 - The FDA’s contentious decision to approve a new Alzheimer’s drug for every single patient with the ...
Posted by Michael Wonder on 11 Jul 2021
Drug prices are one focus of Biden’s push to boost competition
9 July 2021 - Executive order calls for easing access for generics, Canadian drugs to lower costs. ...
Posted by Michael Wonder on 10 Jul 2021
FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug
9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...
Posted by Michael Wonder on 08 Jul 2021
In a reversal, FDA calls for limits on who gets Alzheimer’s drug
8 July 2021 - The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the ...
Posted by Michael Wonder on 06 Jul 2021
Cures for many rare diseases might already exist. Why aren’t we using them?
5 July 2021 - Scientists may have already developed cures for cystic fibrosis, muscular dystrophy, and rare cancers—they just don't realise ...