Blog
RSS FeedPosted by Michael Wonder on 02 Sep 2017
Apricus Biosciences announces FDA acknowledgement of Vitaros Class 2 NDA resubmission
31 August 2017 - Apricus Biosciences today announced that the U.S. FDA has acknowledged receipt of its recently resubmitted new drug ...
Posted by Michael Wonder on 01 Sep 2017
Novartis CEO's dilemma: is $475,000 too much for a leukaemia breakthrough? Or is it not enough?
30 August 2017 - Joseph Jimenez, the chief executive of Novartis, is celebrating a triumph. The Food and Drug Administration approved ...
Posted by Michael Wonder on 01 Sep 2017
A $475,000 price tag for a new cancer drug: crazy or meh?
31 August 2017 - Forget McGregor-Mayweather. The biotech world has been waiting for months to hear about Novartis’s pricing decision ...
Posted by Michael Wonder on 01 Sep 2017
Profit on $475,000 Novartis cancer drug could be a while coming
31 August 2017 - Novartis’s new gene-modifying cancer therapy’s $475,000-per-patient sticker price has drawn fire from advocate groups calling for ...
Posted by Michael Wonder on 01 Sep 2017
FDA approves Mylotarg for treatment of acute myeloid leukaemia
1 September 2017 - The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with ...
Posted by Michael Wonder on 31 Aug 2017
Is $475,000 too high a price for Novartis’s ‘historic’ cancer gene therapy?
31 August 2017 - On Wednesday, Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval ...
Posted by Michael Wonder on 31 Aug 2017
A cancer doctor weighs in on CAR-T, precision medicine and pricing debates
31 August 2017 - Yesterday’s historic FDA approval of the first engineered T-cell treatment for cancer, Novartis’ Kymriah (tisagenlecleucel), was accompanied ...
Posted by Michael Wonder on 31 Aug 2017
USFDA target action date for trastuzumab reset to 3 December 2017
30 August 2017 - The US FDA has notified our partner Mylan that they will extend the target action date for ...
Posted by Michael Wonder on 31 Aug 2017
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
31 August 2017 - Clinical trials play a critically important role in bringing to market innovative new therapies for patients ...
Posted by Michael Wonder on 31 Aug 2017
FDA expands use of Teva’s Austedo in Parkinson’s
31 August 2017 - Teva’s Austedo is now the first and only therapy approved in the US to treat both ...
Posted by Michael Wonder on 31 Aug 2017
Advanced Accelerator Applications announces New Prescription Drug User Fee Act date of 26 January 2018 for Lutetium Lu 177 dotatate (Lutathera)
28 August 2017 - Advanced Accelerator Applications today announced that the US FDA has acknowledged receipt and considered complete the resubmission ...
Posted by Michael Wonder on 31 Aug 2017
FDA approves Genentech’s Actemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome
30 August 2017 - Actemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T ...
Posted by Michael Wonder on 30 Aug 2017
Novartis gene therapy approval signals new cancer treatment era
30 August 2017 - Novartis AG on Wednesday won highly anticipated U.S. approval for the first of a new type ...
Posted by Michael Wonder on 30 Aug 2017
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice
30 August 2017 - Novartis also announces innovative collaboration with the US Centers for Medicare and Medicaid Services. ...
Posted by Michael Wonder on 30 Aug 2017
FDA approval brings first gene therapy to the United States
30 August 2017 - CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukaemia. ...