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RSS FeedPosted by Michael Wonder on 01 Feb 2021
Vyne Therapeutics announces FDA approval of Amzeeq (minocycline) label ppdate
1 February 2021 - Vyne Therapeutics today announced approval by the U.S. FDA to include new information in the product ...
Posted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in ...
Posted by Michael Wonder on 01 Feb 2021
Patient advocate slams cancer agency report over 'wall of silence' on PHARMAC funding
2 February 2021 - The Cancer Control Agency has released its first report into cancer in New Zealand, but one patient ...
Posted by Michael Wonder on 01 Feb 2021
Adamas announces FDA approval for second indication for Gocovri as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes
1 February 2021 - Gocovri is now the first and only medication approved to treat OFF and dyskinesia motor complications. ...
Posted by Michael Wonder on 01 Feb 2021
Biogen announces FDA approval of Plegridy (peginterferon beta-1a) intramuscular administration for multiple sclerosis
1 February 2021 - Intramuscular injection Plegridy (peginterferon beta-1a) is now approved in the U.S. and the European Union, offering individuals ...
Posted by Michael Wonder on 01 Feb 2021
Incyte announces positive CHMP opinion for pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 January 2021 - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication. ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...
Posted by Michael Wonder on 31 Jan 2021
Amarin receives positive CHMP opinion for icosapent ethyl for cardiovascular risk reduction
29 January 2021 - Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT cardiovascular outcomes trial. ...
Posted by Michael Wonder on 31 Jan 2021
New Zealand Pharmaceutical Schedule - 1 February 2021
1 February 2021 - The February 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Jan 2021
Schedule of Pharmaceutical Benefits - 1 February 2021
1 February 2021 - The February 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Jan 2021
New PBS listing brings greater hope for Australians with pulmonary arterial hypertension
31 January 2021 - Australians with a rare, fatal heart condition will soon have subsidised access to a ground-breaking medicine ...
Posted by Michael Wonder on 31 Jan 2021
Greater access to life-changing medicine for Australians with ADHD
30 January 2021 - On 1 February, the Government is expanding the listing of Vyvanse (lisdexamphetamine) to include patients who ...
Posted by Michael Wonder on 30 Jan 2021
TGA approves first new medicine for 2021
31 January 2021 - The TGA approved Aklief (trifarotene) for the topical treatment of acne vulgaris of the face and/or the ...
Posted by Michael Wonder on 30 Jan 2021
Phase 1 drug candidate GLR2007 developed by Gan & Lee has been granted fast track designation by the U.S. FDA
29 January 2021 - Gan & Lee Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for GLR2007, ...
Posted by Michael Wonder on 29 Jan 2021
Novartis receives positive CHMP opinion for Kesimpta (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 January 2021 - CHMP opinion is based on two Phase 3 ASCLEPIOS trials that met the primary outcomes where Kesimpta ...