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RSS FeedPosted by Michael Wonder on 20 Feb 2019
Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)
19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...
Posted by Michael Wonder on 20 Feb 2019
Gilead receives approval in Canada for Yescarta (axicabtagene ciloleucel) CAR T therapy for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
19 February 2019 - Yescarta is a chimeric antigen receptor T-cell therapy that is custom-made for each patient from his or ...
Posted by Michael Wonder on 20 Feb 2019
Pfizer receives European approval for Zirabev (bevacizumab), a biosimilar to Avastin
19 February 2019 - Pfizer today announced the European Commission has approved Zirabev for the treatment of metastatic carcinoma of ...
Posted by Michael Wonder on 20 Feb 2019
FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
19 February 2019 - U.S. approval based on significant recurrence-free survival benefit demonstrated with Keytruda in Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...
Posted by Michael Wonder on 19 Feb 2019
Pfenex announces FDA acceptance of NDA for PF708
19 February 2019 - FDA sets PDUFA date of 7 October 2019. ...
Posted by Michael Wonder on 19 Feb 2019
Big opportunities in big data, but EMA and industry just getting started
18 February 2019 - 250m genomes sequenced, but data trapped in silos. ...
Posted by Michael Wonder on 19 Feb 2019
FDA grants priority review to Roche’s personalised medicine entrectinib
19 February 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug ...
Posted by Michael Wonder on 19 Feb 2019
AbbVie announces new drug application accepted for priority review by U.S. FDA for upadacitinib for treatment of moderate to severe rheumatoid arthritis
19 February 2019 - AbbVie used a priority review voucher to expedite review of the upadacitinib NDA. ...
Posted by Michael Wonder on 18 Feb 2019
Bausch Health provides update for Duobrii filing
15 February 2019 - Bausch Health announced that the U.S. FDA will be unable to meet today's Prescription Drug User Fee ...
Posted by Michael Wonder on 16 Feb 2019
OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer
23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...
Posted by Michael Wonder on 16 Feb 2019
Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer
12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...
Posted by Michael Wonder on 16 Feb 2019
Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint
24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...
Posted by Michael Wonder on 16 Feb 2019
Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer
6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...
Posted by Michael Wonder on 16 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma
15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial. ...