Blog
RSS FeedPosted by Michael Wonder on 21 Nov 2017
FDA approval of tisagenlecleucel
21 November 2017 - Promise and complexities of a $475, 000 cancer drug. ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...
Posted by Michael Wonder on 13 Nov 2017
Fortress Biotech announces Cellvation's CEVA101 granted FDA regenerative medicine advanced therapy designation for the treatment of traumatic brain injury
8 November 2017 - CEVA101 is being developed in partnership with The University of Texas Health Science Center at Houston. ...
Posted by Michael Wonder on 31 Oct 2017
Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves another amazing and costly cancer-killing gene therapy
18 October 2017 - In 2010, Josh Feldman was on his honeymoon -- a globe-spanning trip that at one point ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...
Posted by Michael Wonder on 08 Oct 2017
Athersys to present at 2017 Cell & Gene Meeting on the Mesa and announces regenerative medicine advanced therapy designation from FDA
5 October 2017 - Athersys announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience ...
Posted by Michael Wonder on 14 Sep 2017
Tragedy, perseverance, and chance — the story of CAR-T therapy
13 September 2017 - In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia. Though her parents were told that ...
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 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 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 ...