Blog
RSS FeedPosted by Michael Wonder on 19 May 2022
Budget 2022: PHARMAC boost leaves patients cold: 'it won't be enough'
19 May 2022 - PHARMAC has had its biggest ever funding boost, but some New Zealanders fear it still won’t ...
Posted by Michael Wonder on 21 May 2022
Bonesupport receives market authorisation for Cerement G in the US
18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...
Posted by Michael Wonder on 21 May 2022
PTC Therapeutics receives positive CHMP opinion for Upstaza for the treatment of AADC deficiency
20 May 2022 - First ever gene therapy directly administered into the brain. ...
Posted 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
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
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
NeuroMetrix reports that Quell wearable neuromodulation device has received FDA de novo authorisation as first non-pharmacological treatment for fibromyalgia
19 May 2022 - NeuroMetrix today announced U.S. FDAde novo authorisation to market the Quell neuromodulation device as an ...