Blog
RSS FeedPosted by Michael Wonder on 01 Aug 2018
Lundbeck and Otsuka’s Rxulti (brexpiprazole) approved by the European Commission
31 July 2018 - Rxulti (brexpiprazole) has been approved for the treatment of schizophrenia in adults. ...
Posted by Michael Wonder on 01 Aug 2018
Novelion Therapeutics announces marketing authorisation for Myalepta (metreleptin) in the European Union to treat generalised and partial lipodystrophy
31 July 2018 - Myalepta is the first approved therapy in Europe indicated as an adjunct to diet as a replacement ...
Posted by Michael Wonder on 01 Aug 2018
FDA approves blood disorder drug made by Japan's Shionogi
1 August 2018 - The U.S. FDA on Tuesday approved Japan-based Shionogi's treatment for low blood-platelet count or thrombocytopenia in patients ...
Posted by Michael Wonder on 01 Aug 2018
Pfizer receives European approval for oncology biosimilar Trazimera (trastuzumab)
31 July 2018 - The European Commission decision marks the approval of Pfizer's first therapeutic oncology biosimilar. ...
Posted by Michael Wonder on 01 Aug 2018
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for moderately to severely active ulcerative colitis
1 August 2018 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib citrate) 10 mg twice-daily for at ...
Posted by Michael Wonder on 01 Aug 2018
FDA grants breakthrough therapy designation to Daiichi Sankyo’s FLT3 inhibitor quizartinib for relapsed/refractory FLT3-ITD AML
1 August 2018 - Third breakthrough therapy designation granted by FDA for a compound in the oncology pipeline of Daiichi ...
Posted by Michael Wonder on 01 Aug 2018
EMA confirms accelerated assessment procedure for Trogarzo
31 July 2018 - Theratechnologies is pleased to announce that the CHMP of the EMA will review the application for marketing ...
Posted by Michael Wonder on 01 Aug 2018
Eisai and Merck announce FDA grants breakthrough therapy designation for Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) as therapy for previously treated patients with advanced and/or metastatic non-MSI-H/pMMR endometrial carcinoma
31 July 2018 - Eisai and Merck announced today that the U.S. FDA granted breakthrough therapy designation for Lenvima (lenvatinib), the ...
Posted by Michael Wonder on 01 Aug 2018
Fast-tracking of new drugs: getting the balance right
1 August 2018 - In Australia, like the rest of the world, patients and their doctors have a growing desire ...
Posted by Michael Wonder on 31 Jul 2018
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
31 July 2018 - Opdivo is the first and only PD-1 agent with an approved adjuvant therapy indication in the European ...
Posted by Michael Wonder on 31 Jul 2018
Alnylam receives positive CHMP opinion for Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy
27 July 2018 - European Commission decision expected in September. ...
Posted by Michael Wonder on 31 Jul 2018
Soleno Therapeutics receives fast track designation from FDA for DCCR for treatment of Prader-Willi syndrome
30 July 2018 - Phase III clinical trial ongoing at multiple sites in the U.S. ...
Posted by Michael Wonder on 31 Jul 2018
Vertex receives European CHMP positive opinion for Symkevi (tezacaftor/ivacaftor) for people with cystic fibrosis aged 12 and older with certain mutations in the CFTR gene
27 July 2018 - If approved, Symkevi (tezacaftor/ivacaftor)will be Vertex’s third medicine to treat the CFTR protein defect in patients ...
Posted by Michael Wonder on 31 Jul 2018
Nektar Therapeutics announces new drug application for NKTR-181 accepted for review by FDA
30 July 2018 - NKTR-181 is a first-in-class investigational opioid to treat chronic low back pain in adult patients new to ...
Posted by Michael Wonder on 31 Jul 2018
New treatment option for Canadians with metastatic lung cancer
30 July 2018 - Takeda Canada has received Notice of Compliance with conditions approval from Health Canada for Alunbrig (brigatinib) indicated ...