Blog
RSS FeedPosted by Michael Wonder on 05 Sep 2017
Interoperability: FDA’s final guidance on smart, safe, medical device interactions
5 September 2017 - Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is ...
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
SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
31 August 2017 - Company to meet and work with FDA to address issues raised. ...
Posted by Michael Wonder on 03 Sep 2017
Bayer submits biologics license application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of haemophilia A
31 August 2017 - Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals. ...
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 03 Sep 2017
Sanofi receives tentative FDA approval of Admelog (insulin lispro) 100 units/mL
1 September 2017 - Sanofi announced today that the U.S. FDA granted tentative approval for Admelog (insulin lispro injection) 100 ...
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 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 ...