Blog
RSS FeedPosted by Michael Wonder on 06 Nov 2021
Pharmaceutical Benefits Scheme continued dispensing arrangements
5 November 2021 - The Australian Government has extended the Continued Dispensing emergency arrangements until 30 June 2022, when they ...
Posted by Michael Wonder on 03 Nov 2021
Major PHARMAC review delayed nearly 3 months
3 November 2021 - A major review into Government drug buying agency PHARMAC has been delayed by nearly three months. ...
Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 21 Oct 2021
Delivery of Novavax vaccine may be delayed in Australia due to reported manufacturing issues
21 October 2021 - Australians may not get access to the Novavax vaccine this year with reports of manufacturing problems causing ...
Posted by Michael Wonder on 19 Oct 2021
Strategies for generic/biosimilar market entry in Australia
19 October 2021 - After surviving the Great Patent Cliff of 2011–2016, the pharma/biopharma industry finds itself in the Second Great ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...
Posted by Michael Wonder on 21 Sep 2021
Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown
22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...
Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
Posted by Michael Wonder on 02 Sep 2021
Patients in the Netherlands wait 1.5 years for access to new medicines
2 September 2021 - Patients in the Netherlands have to wait an average of 510 days for access to a new ...
Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...
Posted by Michael Wonder on 19 Aug 2021
TGA reduces timeframe for publishing adverse event reports
19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...
Posted by Michael Wonder on 10 Aug 2021
Jason Falinski slams TGA’s slow Moderna Covid vaccine approval
10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...
Posted by Michael Wonder on 04 Aug 2021
FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day
3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...