Blog
RSS FeedPosted by Michael Wonder on 30 Jul 2024
FDA accepts Telix NDA for new prostate cancer imaging agent
23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...
Posted by Michael Wonder on 25 Jul 2024
Switzerland’s drug approval process lags behind Europe
24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...
Posted by Michael Wonder on 16 Jul 2024
Doug Ford wants Canada to approve drugs faster. Is that possible?
15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...
Posted by Michael Wonder on 15 Jul 2024
Clinical benefit, reimbursement outcomes, and prices of FDA approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis
11 July 2024 - Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in ...
Posted by Michael Wonder on 10 Jul 2024
Updates to the HTA Policy and Methods Review
10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...
Posted by Michael Wonder on 03 Jul 2024
HAS clarifies the framework of the “bet” on early access to medicines
24 June 2024 - Committed to a process of continuous development of its methods, the High Authority of Health is launching ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted 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 ...