Blog
RSS FeedPosted by Michael Wonder on 13 Jun 2024
Comparing new medicine availability across Europe
12 June 2024 - Each year, the European Pharmaceutical Industry Association (EFPIA) publishes data comparing the availability of new medicines across ...
Posted by Michael Wonder on 04 Jun 2024
Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections
31 May 2024 - Oral sulopenem NDA has been assigned a PDUFA action date of 25 October 2024. ...
Posted by Michael Wonder on 03 Jun 2024
Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation
31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action ...
Posted by Michael Wonder on 03 Jun 2024
Project Orbis: quicker access to promising cancer treatments
29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...
Posted by Michael Wonder on 24 May 2024
NICE and NHS England announce plan to enable innovative tech to be adopted quicker
23 May 2024 - NHS patients in England will benefit from faster access to the most innovative and cutting-edge medical technologies ...
Posted by Michael Wonder on 21 May 2024
Bristol Myers Squibb announces updated action date by the US FDA for subcutaneous nivolumab (nivolumab and hyaluronidase)
21 May 2024 - Updated PDUFA goal date of 29 December 2024. ...
Posted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 19 Apr 2024
Publication of Stage 1 and Stage 2 PBS Process Improvements metrics report for 2022-23
19 April 2024 - The 2022-23 Stage 1 and Stage 2 PBS process improvements metrics report is now available on ...
Posted by Michael Wonder on 15 Apr 2024
Updates to the HTA Policy and Methods Review Reference Committee (15 April 2024)
15 April 2024 - The HTA Review Reference Committee is finalising its report and recommendations to the Australian Government having ...
Posted by Michael Wonder on 12 Apr 2024
Waiting for new medicines in Canada, Europe, and the United States: study finds Americans get better and faster access to innovative drugs
11 April 2024 - A recent study published by the Canadian Health Policy Institute examined the availability and wait times ...
Posted by Michael Wonder on 10 Apr 2024
New target zero initiative aims to help improve access to new drugs
9 April 2024 - Target Zero is a new initiative that aims to improve the time to access for patients ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 23 Mar 2024
Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...