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RSS FeedPosted by Michael Wonder on 10 May 2022
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
10 May 2022 - Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better ...
Posted by Michael Wonder on 10 May 2022
FDA launches new Accelerating Rare disease Cures (ARC) program
10 May 2022 - FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the launch of the new ...
Posted by Michael Wonder on 08 May 2022
Wearable technology promises to revolutionise health care
5 May 2022 - Do not let bureaucracy delay matters. ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 06 May 2022
Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...
Posted by Michael Wonder on 05 May 2022
FDA Commissioner Califf says business of health is booming in U.S. but patients’ outcomes aren’t improving
4 May 2022 - At a hearing last month, FDA Commissioner Robert Califf pointed to the fact that the U.S. ...
Posted by Michael Wonder on 05 May 2022
FDA's use of adcomms prior to drug approval decreased over the last decade
3 May 2022 - Between 2011 and 2021, the U.S. FDA decreased the use of advisory committees before approving drugs from ...
Posted by Michael Wonder on 21 Apr 2022
Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...
Posted by Michael Wonder on 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...
Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied ...
Posted by Michael Wonder on 19 Apr 2022
Medicare’s decision not to fund Aduhelm changes landscape for US pharma industry
19 April 2022 - The decision by the agency responsible for Medicare to restrict coverage of Biogen’s Alzheimer’s drug aducanumab ...
Posted by Michael Wonder on 13 Apr 2022
Committee releases report uncovering significant conflicts of interest at McKinsey related to work for FDA and opioid manufacturers
13 April 2022 - Chairwoman Maloney calls on McKinsey’s global managing partner to testify at public hearing. ...
Posted by Michael Wonder on 13 Apr 2022
FDA takes important steps to increase racial and ethnic diversity in clinical trials
13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...
Posted by Michael Wonder on 13 Apr 2022
Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain
13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...
Posted by Michael Wonder on 12 Apr 2022
It’s time to fix the FDA by breaking it up
11 April 2022 - A new investigation about the agency’s failures underscores the need for a separate agency to keep our ...