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RSS FeedPosted by Michael Wonder on 30 Sep 2020
ACT would ensure an independent review of PHARMAC
30 September 2020 - “ACT will seek an independent review of PHARMAC’s operating model to allow for greater transparency and ...
Posted by Michael Wonder on 30 Sep 2020
Study identifies shortcomings in FDA evaluations for new opioid drug approvals over two decades
29 September 2020 - Systematic assessment of safety-related outcomes has been lacking, researchers find. ...
Posted by Michael Wonder on 30 Sep 2020
Health Canada approves Reblozyl (luspatercept), new class of treatment for adult patients living with beta thalassaemia
29 September 2020 - Reblozyl is the first and only erythroid maturation agent approved for use in Canada. ...
Posted by Michael Wonder on 29 Sep 2020
Australian patients to benefit from ongoing collaboration between peak medicine bodies
29 September 2020 - ACCC extends conditional authorisation to Medicines Australia and the Generic and Biosimilar Medicines Association ...
Posted by Michael Wonder on 29 Sep 2020
Infinity receives fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced triple negative breast cancer
29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) ...
Posted by Michael Wonder on 29 Sep 2020
Eton Pharmaceuticals announces FDA approval of orphan drug Alkindi Sprinkle (hydrocortisone) as replacement therapy in paediatric patients with adrenocortical insufficiency
29 September 2020 - Alkindi Sprinkle is the first and only FDA approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed ...
Posted by Michael Wonder on 29 Sep 2020
BridgeBio Pharma and affiliate Origin Biosciences announces FDA acceptance of its new drug application for fosdenopterin for the treatment of MoCD type A
29 September 2020 - Application accepted under priority review designation with breakthrough therapy designation and rare paediatric disease designation previously granted. ...
Posted by Michael Wonder on 29 Sep 2020
Trump’s drug pricing ideas would cost taxpayers a bundle
29 September 2020 - Pharmaceutical companies, on the other hand, would stand to make a lot more money. ...
Posted by Michael Wonder on 29 Sep 2020
Assessing claims of clinical superiority; what do the Guidelines say?
30 September 2020 - In considering a submission seeking subsidy of upadacitinib for patients with rheumatoid arthritis in November 2019, ...
Posted by Michael Wonder on 29 Sep 2020
Epidyolex oral solution is not included in the high-cost protection
29 September 2020 - On 28 September 2020, it was decided that Epidyolex is not included in the high-cost protection. ...
Posted by Michael Wonder on 29 Sep 2020
Labour's promised PHARMAC boost 'not enough'
30 September 2020 - Palmerston North cancer patient Lydia Pei looks likely to have to depend on the community, not ...
Posted by Michael Wonder on 29 Sep 2020
California to use market power in bid to lower prescription drug costs
28 September 2020 - California will attempt to use its massive market power to increase the availability and lower the ...
Posted by Michael Wonder on 29 Sep 2020
ICER to assess treatment for Alzheimer’s disease
29 September 2020 - Report will be subject of CTAF meeting in May 2021; open Input now being accepted until ...
Posted by Michael Wonder on 29 Sep 2020
Increase transparency at the FDA: we need sunlight to fight the pandemic
29 September 2020 - The FDA has issued a number of contentious decisions during the COVID-19 pandemic related to investigational ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...