Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)

17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...

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BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia

17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...

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Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer

17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...

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Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira

17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...

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Keytruda made available on the NHS for certain oesophageal cancer patients

17 September 2021 - NICE has recommended MSD’s Keytruda (pembrolizumab) combined with chemotherapy for the first-line treatment of certain oesophageal ...

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ICER releases draft evidence report on therapies for severe asthma

16 September 2021 - Public comment period now open until 14 October 2021; requests to make oral comment during public ...

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Raising the bar for using surrogate outcomes in drug regulation and health technology assessment

16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...

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With remdesivir, the Federal Joint Committee assesses the additional benefit of an anti-viral COVID-19 drug for the first time

16 September 2021 - Do patients with COVID-19 have a better chance of surviving and recovering faster if they are treated ...

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Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison

16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...

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BioCryst’s HAE med Orladeyo wins NICE nod

16 September 2021 - BioCryst’s Orladeyo (berotralstat) has received a positive recommendation from NICE for preventing recurrent attacks of hereditary ...

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Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit

15 September 2021 - Third new area of ​​application/those affected still live a good year on average - and thus ...

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NICE backs Opdivo for head and neck cancer

15 September 2021 - NICE has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS ...

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SMC - September 2021 decisions

13 September 2021 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...

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EMA publishes agenda for 13-16 September CHMP meeting

13 September 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Medicare Benefits Schedule continuous review to improve patient care

13 September 2021 - Medicare items and services will be reviewed by experts on an on-going basis to ensure the Medicare ...

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