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. ...

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Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia

24 June 2022 -  ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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