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 European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer

22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...

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Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C

22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...

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Novartis Tafinlar and Mekinist receives FDA approval for first tumour agnostic indication for BRAF V600E solid tumours

22 June 2022 - Approval supported by results from Phase II ROAR and NCI-MATCH studies demonstrating overall response rates up to ...

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MSAC publishes agenda for October 2022 ESC meeting

22 June 2022 - The MSAC Secretariat has published a list of applications scheduled to be considered by the ESC on ...

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New $11 million winter vaccine communication campaign and availability of antivirals

22 June 2022 - The Australian Government today launched an $11 million six-week campaign to encourage people to get vaccinated for ...

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Slow release potassium bicarbonate–potassium citrate for treating distal renal tubular acidosis

21 June 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using slow-release ...

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U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children

22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...

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Krystal Biotech submits biologics license application to U.S. FDA seeking approval of B-VEC for the treatment of patients with dystrophic epidermolysis bullosa

22 June 2022 - Krystal Biotech announced today the submission of a biologics license application to the U.S. FDA seeking ...

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Ikena Oncology receives FDA fast track designation for novel TEAD inhibitor IK-930 to treat unresectable NF2 deficient mesothelioma

22 June 2022 - Ikena Oncology today announced that the U.S. FDA has granted fast track designation for IK-930, the Company’s ...

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BioMarin announces the Ministry of Health, Labor and Welfare in Japan granted approval for Voxzogo (vosoritide) for injection for the treatment of children with achondroplasia, whose growth plates are not closed

21 June 2022 - No lower age restriction for treatment. ...

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FDA grants breakthrough device designation to VR mental illness treatment

22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...

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Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease

22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...

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Paratek Pharmaceuticals’ Nuzyra receives FDA fast track designation for the treatment of pulmonary non-tuberculous mycobacterial disease caused by mycobacterium avium complex and mycobacterium abscessus

21 June 2022 - Phase 2b study in MAB pulmonary infections on-going and enrolling as planned. ...

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EQRx announces acceptance of marketing authorisation application by the UK's Medicines and Healthcare Products Regulatory Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

14 June 2022 - Application is based on data from pivotal Phase 3 AENEAS trial in the first-line treatment of EGFR ...

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Medicare could’ve saved $3.6 billion by buying drugs at same prices as Mark Cuban’s online pharmacy, according to a new study

22 June 2022 - Medicare’s drug program could have saved up to $3.6 billion in 2020 by mirroring the pricing ...

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