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RSS FeedPosted by Michael Wonder on 19 Sep 2021
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. ...
Posted by Michael Wonder on 19 Sep 2021
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 ...
Posted by Michael Wonder on 18 Sep 2021
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 ...
Posted by Michael Wonder on 18 Sep 2021
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 ...
Posted by Michael Wonder on 17 Sep 2021
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 ...
Posted by Michael Wonder on 17 Sep 2021
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 ...
Posted by Michael Wonder on 16 Sep 2021
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 ...
Posted by Michael Wonder on 16 Sep 2021
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 ...
Posted by Michael Wonder on 16 Sep 2021
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 ...
Posted by Michael Wonder on 16 Sep 2021
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 ...
Posted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 13 Sep 2021
SMC - September 2021 decisions
13 September 2021 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 13 Sep 2021
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. ...
Posted by Michael Wonder on 13 Sep 2021
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 ...