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RSS FeedPosted by Michael Wonder on 13 Sep 2017
Array BioPharma announces FDA acceptance for review of binimetinib and encorafenib new drug applications for patients with advanced BRAF-mutant melanoma
12 September 2017 - Array BioPharma today announced that the U.S. FDA has accepted for review its new drug applications to ...
Posted by Michael Wonder on 09 Sep 2017
Sanofi and Regeneron announce that cemiplimab (REGN2810) has received FDA breakthrough therapy designation for advanced cutaneous squamous cell carcinoma
8 September 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 07 Sep 2017
Verastem expands duvelisib development program to include peripheral T-cell lymphoma
6 Septemner 2017 - Duvelisib receives fast track designation from FDA in peripheral T-cell lymphoma; company to initiate a phase 2 ...
Posted by Michael Wonder on 04 Sep 2017
At $475,000, new cancer drug raises thorny questions about drug pricing — and value
4 September 2017 - A first-of-its-kind cancer treatment is generating unbridled excitement — but also underscoring intense concerns over pricing ...
Posted by Michael Wonder on 03 Sep 2017
FDA accepts Amgen's filing of a supplemental new drug application to add overall survival results to Kyprolis (carfilzomib) label
30 August 2017 - FDA sets PDUFA target action date of 30 April 2018 ...
Posted by Michael Wonder on 02 Sep 2017
Iovance Biotherapeutics announces FDA fast track designation for LN-144 for treatment of advanced melanoma
31 August 2017 - Iovance Biotherapeutics today announced that the U.S. FDA has granted fast track designation for LN-144, the Company’s ...
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
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 ...