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RSS FeedPosted by Michael Wonder on 21 May 2022
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukaemia
20 May 2022 - Today the FDA approved azacitidine (Vidaza, Celgene) for paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia. ...
Posted by Michael Wonder on 21 May 2022
People dying of COVID while life-saving drugs go unused, doctors say
21 May 2022 - Top doctors have warned that vulnerable patients who test positive to COVID-19 are missing out on ...
Posted by Michael Wonder on 21 May 2022
CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD
20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS ...
Posted by Michael Wonder on 21 May 2022
Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma
20 May 2022 - European Commission decision anticipated within approximately 60 days. ...
Posted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 20 May 2022
FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder
20 May 2022 - Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis in adults and ...
Posted by Michael Wonder on 20 May 2022
CHMP recommends approval of Lilly and Incyte's Olumiant (baricitinib) as the first and only centrally authorised treatment for adults with severe alopecia areata
20 May 2022 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for ...
Posted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
Posted by Michael Wonder on 20 May 2022
Highlights from the 16-19 May 2022 CHMP meeting
20 May 2022 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. ...
Posted by Michael Wonder on 20 May 2022
Lumasiran for treating primary hyperoxaluria type 1
20 May 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using lumasiran ...
Posted by Michael Wonder on 20 May 2022
Mirati Therapeutics submits marketing authorisation application to the European Medicines Agency for investigational adagrasib as a treatment for previously treated KRASG12C mutated non-small-cell lung cancer
19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...
Posted by Michael Wonder on 19 May 2022
Medicines Australia puts spotlight on reform priority for the next Government
20 May 2022 - Medicines Australia has set the scene for major health reform by the next Government by alerting ...
Posted by Michael Wonder on 19 May 2022
Plea to make new depression 'spray' affordable
19 May 2022 - Mental health experts say a nasal spray to help relieve depression should be subsidised to make ...
Posted by Michael Wonder on 19 May 2022
Major parties committed to major medicines policy reform and reviews – whoever wins on Saturday
19 May 2022 - Medicines Australia has been assured in official communications from the respective Campaign Headquarters that both the ...
Posted by Michael Wonder on 19 May 2022
BMS’ Sprycel reimbursement criteria to be broadened for paediatric Philadelphia chromosome positive ALL
19 May 2022 - The state health insurance review agency said it would broaden the reimbursement criteria for Sprycel (dasatinib), ...