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RSS FeedPosted by Michael Wonder on 22 Sep 2023
PMPRB report shows increased plan costs, promising pharmaceutical innovation: expert
20 September 2023 - A recent report by the Patented Medicine Prices Review Board shows increased growth for private drug ...
Posted by Michael Wonder on 24 Sep 2023
New rules for weight loss ‘wonder drug’ after regulator clamp down
23 September 2023 - Australia’s pharmaceuticals regulator has ushered in new rules for a diabetes drug, which is being hailed by ...
Posted by Michael Wonder on 24 Sep 2023
NICE recommends Lilly's mirikizumab (Omvoh) for the treatment of eligible adults with moderately to severely active ulcerative colitis
22 September 2023 - Eli Lilly announced today that NICE has recommended mirikizumab for the treatment of adults with moderately ...
Posted by Michael Wonder on 24 Sep 2023
US FDA approves Jardiance for the treatment of adults with chronic kidney disease
22 September 2023 - Jardiance (empagliflozin) 10 mg tablets significantly reduced the risk of kidney disease progression and cardiovascular death in ...
Posted by Michael Wonder on 24 Sep 2023
MicuRx receives FDA qualified infectious disease product and fast track designation for contezolid and contezolid acefosamil
22 September 2023 - MicuRx Pharmaceuticals today announced that the US FDA has granted Qualified Infectious Disease Product and the fast ...
Posted by Michael Wonder on 23 Sep 2023
Jazz Pharmaceuticals receives European Commission approval for Enrylaze (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
Posted by Michael Wonder on 23 Sep 2023
argenx announces Vyvgart (efgartigimod alfa) authorised for sale by Health Canada for generalised myasthenia gravis
21 September 2023 - Approval based on the positive Phase 3 ADAPT trial (p<0.0001) showing 68% of Vyvgart treated patients were ...
Posted by Michael Wonder on 23 Sep 2023
European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention
19 September 2023 - Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral ...
Posted by Michael Wonder on 22 Sep 2023
Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.
21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...
Posted by Michael Wonder on 22 Sep 2023
89bio announces US FDA has granted breakthrough therapy designation for pegozafermin in non-alcoholic steatohepatitis
21 September 2023 - Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of ...
Posted by Michael Wonder on 21 Sep 2023
Updates to the Health Technology Assessment Policy and Methods Review Reference Committee – 22 September 2023
21 September 2023 - The agenda for this week's HTA Review Reference Committee meeting is now available. ...
Posted by Michael Wonder on 21 Sep 2023
The Inflation Reduction Act and access to high cost cardiovascular therapies
20 September 2023 - On August 29, 2023, the Biden-Harris administration announced the first 10 drugs selected for Medicare price ...
Posted by Michael Wonder on 21 Sep 2023
Medicare’s historic prescription drug price negotiations
20 September 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs whose prices will be ...
Posted by Michael Wonder on 21 Sep 2023
BeiGene announces positive regulatory updates in Europe and the US after recently regaining global rights for Tevimbra
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma. ...
Posted by Michael Wonder on 21 Sep 2023
Supply and insurance issues snarl fall COVID-19 vaccine campaign for some
20 September 2023 - It has been just over a week since the US FDA and the US Centers for ...