Blog
RSS FeedPosted by Michael Wonder on 20 Jun 2022
FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
Posted by Michael Wonder on 13 Jun 2022
BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 07 Jun 2022
Response to engagement on proposals for the Innovative Medicines Fund
7 June 2022 - NHS England and NICE asked for comments on our proposals for the Innovative Medicines Fund. ...
Posted by Michael Wonder on 07 Jun 2022
Patients to have earlier access to cutting edge treatments on NHS
7 June 2022 - The most promising medicines will be fast-tracked to NHS patients through Innovative Medicines Fund ...
Posted by Michael Wonder on 04 Jun 2022
Amylyx Pharmaceuticals receives notification of PDUFA date extension for AMX0035 for the treatment of ALS
3 June 2022 - New PDUFA goal date scheduled for 29 September 2022 to allow time to review additional data ...
Posted by Michael Wonder on 31 May 2022
argenx announces the UK MHRA has granted early access to efgartigimod for generalised myasthenia gravis
31 May 2022 - Efgartigimod was granted a promising innovative medicine designation by UK’s MHRA in November 2021. ...
Posted by Michael Wonder on 31 May 2022
TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab to treat patients with RMS
31 May 2022 - New PDUFA goal date of 28 December 2022. ...
Posted by Michael Wonder on 22 May 2022
Patients deserve immediate access to FDA approved innovations — not bureaucratic restrictions
21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...
Posted by Michael Wonder on 11 May 2022
Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA
10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...
Posted by Michael Wonder on 20 Apr 2022
Making #MedicinesMatter for all Australians
21 April 2022 - Medicines Australia has launched a social media campaign to highlight key policy issues for the election ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 13 Apr 2022
Irish cancer patients wait four months longer for access to new drugs than rest of Europe
11 April 2022 - Cancer patients in Ireland are waiting on average four months longer than people with the disease ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 10 Apr 2022
Faster patient access to new medicines must be a priority for next Government
10 April 2022 - With the Federal Election campaign now formally underway, Medicines Australia is reminding the major parties of ...