Blog
RSS FeedPosted by Michael Wonder on 10 Oct 2022
Monkeypox vaccine not expected in NZ until December as community spread confirmed
10 October 2022 - New Zealand now has community transmission of monkeypox, but a vaccine to protect those at highest ...
Posted by Michael Wonder on 04 Oct 2022
Split Real Time Application Review (STAR)
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...
Posted by Michael Wonder on 14 Sep 2022
Has there actually been early resolution for early resolution resubmissions?
15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 22 Aug 2022
Monkeypox vaccines not expected until December
20 August 2022 - Monkeypox vaccines aren't expected to arrive in New Zealand until December, according to PHARMAC. ...
Posted by Michael Wonder on 12 Aug 2022
Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld
12 August 2022 - Half a million people in the UK with conditions like blood cancer that prevents them being ...
Posted by Michael Wonder on 10 Aug 2022
Few U.S. patients with hepatitis C get timely treatment, CDC says
9 August 2022 - Few U.S. adults diagnosed with hepatitis C virus infection receive timely treatment with anti-viral drugs, the ...
Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023. ...
Posted 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 ...