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RSS FeedPosted by Michael Wonder on 18 Aug 2022
Stability of changes in health status: next step in comprehensively assessing patient reported outcomes
18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...
Posted by Michael Wonder on 18 Aug 2022
AARP Pennsylvania convenes discussion on lower prescription drug costs after Inflation Reduction Act signed into law
18 August 2022 - Senator Bob Casey joins AARP Discussion. ...
Posted by Michael Wonder on 18 Aug 2022
Caps on prescription drug price hikes most popular aspect of Inflation Reduction Act: poll
18 August 2022 - A cap on prescription drug price increases is the most popular part of the Inflation Reduction ...
Posted by Michael Wonder on 18 Aug 2022
Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate
18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 18 Aug 2022
FDA label update reflects Bayer’s commitment to providing options for long-acting contraception
18 August 2022 - FDA approves extension of Mirena (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device for up to eight years ...
Posted by Michael Wonder on 18 Aug 2022
U.S. FDA accepts Astellas' new drug application for fezolinetant
18 August 2022 - If approved by the FDA, fezolinetant would be a non-hormonal treatment for moderate to severe vasomotor ...
Posted by Michael Wonder on 17 Aug 2022
Early phase oncology trials: why so many designs?
12 August 2022 - The past 30 years have seen a considerable effort on the part of statisticians to improve the ...
Posted by Michael Wonder on 17 Aug 2022
bluebird bio announces U.S. commercial infrastructure to enable patient access to Zynteglo, the first and only FDA approved gene therapy for people with beta thalassaemia who require regular red blood cell transfusions
17 August 2022 - Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing. ...
Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
Posted by Michael Wonder on 17 Aug 2022
FDA approves first cell based gene therapy to treat adult and paediatric patients with beta thalassaemia who require regular blood transfusions
17 August 2022 - Today, the US FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of ...
Posted by Michael Wonder on 17 Aug 2022
Samsung Bioepis and Organon announce FDA approval of citrate free high concentration Humira biosimilar Hadlima (adalimumab-bwwd)
17 August 2022 - Samsung Bioepis and Organon today announced the U.S. FDA has approved the citrate free, high concentration (100 ...
Posted by Michael Wonder on 17 Aug 2022
Akorn announces FDA has approved generic cetrorelix acetate
16 August 2022 - Akorn announces that it received FDA approval for a generic version of cetrorelix acetate 250 mcg ...
Posted by Michael Wonder on 17 Aug 2022
US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis
17 February 2022 - Regulatory submission included data from the pivotal MOMENTUM Phase 3 clinical trial that met all primary ...
Posted by Michael Wonder on 16 Aug 2022
Sales from controversial drug discount program rose to $44 billion last year
15 August 2022 - Prescription medicines purchased in the US under a controversial government discount program amounted to $44 billion ...
Posted by Michael Wonder on 16 Aug 2022
Cancer patient who devoted six years to drug pricing reform isn’t done yet
14 August 2022 - After six years of relentless advocacy work, David Mitchell was finally on the cusp of defeating ...