Blog
RSS FeedPosted by Michael Wonder on 11 Aug 2021
Vulnerable Senate Democrats escalate a push for Medicare to negotiate drug prices
11 August 2021 - Five of the most vulnerable Democrats in the Senate on Tuesday publicly renewed their push to ...
Posted by Michael Wonder on 11 Aug 2021
Pressure builds for full FDA approval of vaccines
11 August 2021 - Pressure is building for the FDA to fully approve the COVID-19 vaccine, a step that could ...
Posted by Michael Wonder on 11 Aug 2021
PhRMA’s misleading description of Medicare drug price legislation
10 August 2021 - “They want to repeal a protection in Medicare that protects access to my medicines. They call ...
Posted by Michael Wonder on 10 Aug 2021
After court defeat, FDA shifts to regulating some drugs as devices
9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 09 Aug 2021
HHS proposes nixing Trump rule tying drug costs to foreign rates
7 August 2021 - Issue previously raised in Trump administration. ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...
Posted by Michael Wonder on 08 Aug 2021
Biden yet to nominate new FDA chief even as delta surges
8 August 2021 - President Biden has yet to nominate a permanent head of the FDA at a time when ...
Posted by Michael Wonder on 06 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...
Posted by Michael Wonder on 05 Aug 2021
Canadian agency loses a battle in effort to force a drug maker to lower ‘excessive’ pricing
4 August 2021 - In a withering ruling, a Canadian appeals court overturned a controversial decision issued four years ago ...
Posted by Michael Wonder on 05 Aug 2021
Pfizer epilepsy drug prices were 'unfairly high,' UK review finds
5 August 2021 - Britain's competition watchdog is sticking with its view that Pfizer and Flynn Pharma broke the law ...
Posted by Michael Wonder on 04 Aug 2021
Court topples Canadian ruling that one of world's most expensive drugs is excessively priced
3 August 2021 - Soliris was originally approved to treat two blood disorders affecting about 180 Canadians, with the list price ...
Posted by Michael Wonder on 04 Aug 2021
Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
4 August 2021 - The federal watchdog at the Department of Health and Human Services will review the process used ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...