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RSS FeedPosted by Michael Wonder on 17 Aug 2022
Fears for patient safety with hundreds of medicines in short supply
17 August 2022 - Doctors and pharmacists are warning there could be serious consequences for patients if the shortage of hundreds ...
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
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 17 Aug 2022
UK will not buy Evusheld owing to “insufficient data” on protection, Government says
15 August 2022 - The UK Government has said that it will not procure the COVID-19 drug Evusheld—a combination of ...
Posted by Michael Wonder on 17 Aug 2022
PHARMAC estimates Trikafta could give people with CF another 27 years
17 August 2022 - PHARMAC has today published the record of advice from the May PTAC meeting to again consider ...
Posted by Michael Wonder on 17 Aug 2022
Restart of the National Medicines Policy review – further consultation on a revised draft
17 August 2022 - The Department of Health and Aged Care is inviting stakeholders to provide feedback on a revised ...
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 ...
Posted by Michael Wonder on 16 Aug 2022
Unpacking the drug pricing policies that Congress just approved
16 August 2022 - Medicare coverage for prescription drugs will look very different when President Biden signs into law the ...
Posted by Michael Wonder on 16 Aug 2022
Otsuka Canada Pharmaceutical announces Health Canada approval of Korsuva (difelikefalin) for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult haemodialysis patients
16 August 2022 - Launch of Korsuva in Canada is expected in the second quarter of 2023. ...
Posted by Michael Wonder on 16 Aug 2022
EMA publishes agenda for 16-19 August CHMP meeting
16 August 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Aug 2022
Chugai obtains regulatory approval for osteoporosis treatment Edirol
15 August 2022 - Chugai Pharmaceutical and Towa Pharmaceutical announced that Chugai obtained regulatory approval from the MHLW for an ...
Posted by Michael Wonder on 16 Aug 2022
FDA accepts supplemental biologics license application for Genentech's Polivy combination for people with previously untreated diffuse large B-cell lymphoma
15 August 2022 - Application is based on pivotal data from the Phase 3 POLARIX study showing Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 16 Aug 2022
Lynparza in combination with abiraterone granted priority review in the US for patients with metastatic castration-resistant prostate cancer
16 August 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent irrespective of ...
Posted by Michael Wonder on 15 Aug 2022
Newly launched US drugs head toward record high prices in 2022
15 August 2022 - Drugmakers are launching new medicines at record high prices this year, a Reuters analysis has found, ...