Blog
RSS FeedPosted by Michael Wonder on 30 Jun 2022
Schedule of Pharmaceutical Benefits - 1 July 2022
1 July 2022 - The July 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 25 Jun 2022
Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia
24 June 2022 - ...
Posted by Michael Wonder on 24 Jun 2022
European Commission approves Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa
23 June 2022 - Filsuvez will be the first and only approved treatment for epidermolysis bullosa patients. ...
Posted by Michael Wonder on 24 Jun 2022
Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer
23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 24 Jun 2022
Astellas submits fezolinetant new drug application to U.S. FDA
24 June 2022 - Application targets treatment of moderate to severe vasomotor symptoms associated with menopause ...
Posted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 23 Jun 2022
FDA explains when it will rescind breakthrough designations
23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...
Posted by Michael Wonder on 23 Jun 2022
Calls to expand access to oral COVID-19 drugs as expiry dates loom
23 June 2022 - Thousands of doses of expensive anti-viral drugs could be wasted if more Australians do not become ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
Industry sponsorship bias in cost effectiveness analysis: registry based analysis
22 June 2022 - The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 23 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab injection) by China NMPA in combination with chemotherapy as first-line treatment for oesophageal squamous cell carcinoma
20 June 2022 - Innovent Biologics and Eli Lilly today announced that the Center for Drug Evaluation of China's National ...
Posted by Michael Wonder on 23 Jun 2022
NICE opts to reject Acorda’s MS drug Fampyra
22 June 2022 - NICE has announced its decision to reject Fampyra – also known as fampridine – for use ...
Posted by Michael Wonder on 23 Jun 2022
COVID-19 vaccine weekly safety report (23 June 2022)
23 June 2022 - To 19 June 2022, the TGA has received 581 reports which have been assessed as likely to ...
Posted by Michael Wonder on 23 Jun 2022
Menarini Group and Radius Health submit new drug application to the U.S. FDA for elacestrant
22 June 2022 - Priority review requested; if accepted, anticipate an 8 month FDA review. ...