Blog
RSS FeedPosted by Michael Wonder on 02 Aug 2022
Delay of Evrysdi reimbursement review denies SMA patients' right to drug choice
2 August 2022 - The Government has been dragging its feet to review insurance benefits for Roche's new spinal muscular ...
Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
Posted by Michael Wonder on 18 Jul 2022
Aussies could get omicron targeted jab earlier than most
18 July 2022 - Australia could become one of the first countries in the world to administer an omicron-specific vaccine, ...
Posted by Michael Wonder on 15 Jul 2022
UK lags behind EU in authorising new medicines after Brexit
14 July 2022 - Experts attribute shortfall to small size of British market now it is regulated separately and complexity of ...
Posted by Michael Wonder on 14 Jul 2022
BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
Posted by Michael Wonder on 11 Jul 2022
PHARMAC ‘procrastinating’ over funding glucose monitors, Diabetes NZ says
12 July 2022 - PHARMAC should stop procrastinating on funding glucose monitors for people with diabetes after the Government agency ...
Posted 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. ...