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RSS FeedPosted by Michael Wonder on 07 Aug 2022
Drug price bill pruned in Senate in partial industry win
6 August 2022 - Medicare to be allowed to negotiate drug prices for first time. ...
Posted by Michael Wonder on 06 Aug 2022
US Government about to get long awaited powers on drug pricing
6 August 2022 - Pharma rarely loses in Washington. For years, the industry has successfully defeated US Government efforts to rein ...
Posted by Michael Wonder on 04 Aug 2022
U.S. regulators defend requiring more data on monkeypox drug
4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...
Posted by Michael Wonder on 02 Aug 2022
Critics decry drug pricing provisions in Inflation Reduction Act, say they will stifle innovation
2 August 2022 - The push back against the prescription drug pricing provisions in the Inflation Reduction Act is relentless and ...
Posted by Michael Wonder on 02 Aug 2022
FDA official: patients play an increasing role in rare disease drug development
1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...
Posted by Michael Wonder on 02 Aug 2022
Characteristics of key patents covering recent FDA approved drugs
1 August 2022 - New drugs are protected by patents that block generic competition and allow manufacturers to charge high prices. ...
Posted by Michael Wonder on 01 Aug 2022
FDA may approve first OTC birth control pill In U.S.: more novel prescription to OTC switches could be on tap
1 August 2022 - The French drug maker HRA Pharma is seeking approval from the Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 31 Jul 2022
FDA provides update on agency response to monkeypox outbreak
29 July 2022 - Today, the U.S. FDA is providing an update on its multi-pronged response to monkeypox in the United ...
Posted by Michael Wonder on 31 Jul 2022
U.S. would gain power to negotiate drug prices under Manchin-Schumer Bill
31 July 2022 - Legislation would also cap out of pocket drug costs for Medicare beneficiaries at $2,000 a year. ...
Posted by Michael Wonder on 31 Jul 2022
2022 October price disclosure cycle – patient savings
29 July 2022 - Indicative brand price reductions and patient savings resulting from the 2022 October Cycle of Price Disclosure have ...
Posted by Michael Wonder on 28 Jul 2022
Drug industry poised for rare political loss on prices
28 July 2022 - Senate deal giving Medicare limited authority to negotiate prices would chip at power of Big Pharma. ...
Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
Posted by Michael Wonder on 26 Jul 2022
The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics
26 July 2022 - Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what currently ...
Posted by Michael Wonder on 26 Jul 2022
Pfizer loses U.S. appeal over co-pays for heart failure patients
26 July 2022 - A federal appeals court on Monday rejected Pfizer's challenge to a U.S. anti-kickback law the drugmaker ...
Posted by Michael Wonder on 25 Jul 2022
FDA describes plans to expand remote regulatory assessments
22 July 2022 - The US FDA released draft guidance on Friday that formalises its plans for using remote regulatory assessments ...