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RSS FeedPosted by Michael Wonder on 27 Jan 2021
NICE publishes final guidance on new use for Lonsurf
27 January 2021 - NICE has completed its review of trifluridine with tipiracil hydrochloride for the treatment of patients with ...
Posted by Michael Wonder on 27 Jan 2021
European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease
27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...
Posted by Michael Wonder on 27 Jan 2021
European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...
Posted by Michael Wonder on 27 Jan 2021
NICE recommends Revlimid for newly diagnosed multiple myeloma patients
27 January 2021 - Bristol Myers Squibb’s Revlimid (lenalidomide) has received a recommendation from the UK’s NICE for newly diagnosed ...
Posted by Michael Wonder on 26 Jan 2021
NICE publishes second appraisal consultation document for Zytiga
26 January 2021 - NICE has had another look at abiraterone acetate for the treatment of patients with newly diagnosed ...
Posted by Michael Wonder on 26 Jan 2021
Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma
26 January 2021 - Symbicort Turbuhaler becomes the first dual-combination therapy approved in China for mild, moderate and severe asthma ...
Posted by Michael Wonder on 26 Jan 2021
Albireo announces U.S. FDA acceptance of new drug application for odevixibat
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
Posted by Michael Wonder on 26 Jan 2021
Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves AbbVie's Rinvoq (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis
25 January 2021 - Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jan 2021
Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia
25 January 2021 - 88% of patients on Calquence remained free of disease progression after 12 months vs. 68% for ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...
Posted by Michael Wonder on 25 Jan 2021
FDA grants toripalimab fast track designation for mucosal melanoma
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...