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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Sierra Oncology announces submission of new drug application for momelotinib to US Food & Drug Administration

17 June 2022 - Submission seeks approval of momelotinib for the treatment of myelofibrosis. ...

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NICE recommends new targeted treatment for early breast cancer

16 June 2022 - NICE has provisionally approved a new treatment for early breast cancer that it says will benefit ...

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Skyrizi (risankizumab-rzaa) receives FDA approval as the first and only specific interleukin-23 to treat moderately to severely active Crohn's disease in adults

17 June 2022 - Third approved indication for risankizumab-rzaa is supported by safety and efficacy data from two induction and one ...

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Outcomes of the May 2022 PBAC intracycle meeting

17 June 2022 - The outcomes from the May 2022 PBAC meeting are now available. ...

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Public consultation: draft 2022-23 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP

17 June 2022 - Consultation on the content of the draft 2022-23 Cost Recovery Implementation Statement (CRIS) for listing medicines ...

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Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...

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COVID-19 vaccine weekly safety report (16 June 2022)

16 June 2022 - To 12 June 2022, the TGA has received 584 reports which have been assessed as likely to ...

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Core network partners announced for CADTH’s post-market drug evaluation network

10 June 2022 - CADTH is pleased to announce the four successful core network partners of its inaugural post-market drug ...

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NHS lands breakthrough in global battle against superbugs

15 June 2022 - The NHS is set to roll out two ‘superbug’ busting drugs through a world first, pioneering ...

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MHRA joins international partnerships to set global standards for medicines and medical devices regulation

16 June 2022 - These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for ...

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Savara awarded innovation passport in United Kingdom for molgramostim nebuliser solution, a novel investigational inhaled biologic

16 June 2022 - Innovation passport awarded to molgramostim for the treatment of auto-immune pulmonary alveolar proteinosis, a rare lung disease. ...

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Subsidy for medicine for Duchenne muscular dystrophy expires

16 June 2022 - The TLV has decided that Translarna, which is subsidised for patients with Duchenne muscular dystrophy, will not ...

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Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for use in patients with Bardet-Biedl syndrome

16 June 2022 - Approval based on Phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in ...

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Former FDA officials call for more transparency for drug approvals

15 June 2022 - The US FDA needs to take a more proactive approach in combatting misinformation and communicating decisions to ...

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Novartis receives GB licence for Scemblix (asciminib), the first STAMP inhibitor for patients with chronic myeloid leukaemia

16 June 2022 - Asciminib is the first treatment in its class to be authorised in Great Britain. ...

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