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RSS FeedPosted by Michael Wonder on 01 Jun 2021
PHARMAC petition tabled at Parliament
1 June 2021 - A petition with more than 100,000 signatures has today been tabled at Parliament after being accepted ...
Posted by Michael Wonder on 01 Jun 2021
CTI BioPharma announces acceptance of NDA granted with priority review of pacritinib for treatment of patients with myelofibrosis
1 June 2021 - PDUFA action date 30 November 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Janssen announces U.S. FDA breakthrough therapy designation granted for teclistamab for the treatment of relapsed or refractory multiple myeloma
1 June 2021 - U.S. milestone follows EMA PRIME designation for this BCMA bi-specific antibody for the treatment of relapsed or ...
Posted by Michael Wonder on 01 Jun 2021
BridgeBio Pharma receives FDA fast track designation for encaleret for the treatment of autosomal dominant hypocalcaemia type 1
1 June 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation for encaleret for the treatment ...
Posted by Michael Wonder on 01 Jun 2021
Paratek Pharmaceuticals announces FDA approval of Nuzyra (omadacycline) oral only dosing regimen for the treatment of community-acquired bacterial pneumonia
1 June 2021 - Oral only dosing for the treatment of CABP expands the commercial opportunity for primary care promotion. ...
Posted by Michael Wonder on 01 Jun 2021
Mycovia Pharmaceuticals submits new drug application to the U.S. FDA for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
1 June 2021 - Oteseconazole’s qualified infectious disease product and fast track designations allow for six month priority review by FDA ...
Posted by Michael Wonder on 01 Jun 2021
Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar I disorder
1 June 2021 - Commercial launch planned for fourth quarter 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Akebia and Otsuka announce FDA acceptance for filing of new drug application for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
1 June 2021 - Vadadustat assigned PDUFA target action date of 29 March 2022. ...
Posted by Michael Wonder on 01 Jun 2021
BeyondSpring announces U.S. FDA acceptance and priority review of new drug application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
1 June 2021 - The FDA has set a Prescription Drug User Fee Act target action date for 30 November 2021. ...
Posted by Michael Wonder on 01 Jun 2021
EMA and EUnetHTA take stock of their co-operation
1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...
Posted by Michael Wonder on 31 May 2021
New EU health innovation rules edge closer
29 May 2021 - Three years after the original proposal, the European Union’s game changing Health Technology Assessment dossier has ...
Posted by Michael Wonder on 31 May 2021
Roche Canada announces collaboration to improve access to personalised health care with real world evidence
28 May 2021 - BC Cancer, CPHIN and Roche Canada will co-create an evidence-generating framework to leverage real-world data and facilitate ...
Posted by Michael Wonder on 31 May 2021
Schedule of Pharmaceutical Benefits - 1 June 2021
1 June 2021 - The June 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 May 2021
New Zealand Pharmaceutical Schedule - 1 June 2021 update
1 June 2021 - The June 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 May 2021
Eton Pharmaceuticals receives complete response letter from U.S. FDA for dehydrated alcohol injection
28 May 2021 - Eton Pharmaceuticals today announced that the company has received a complete response letter from the U.S. FDA ...