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RSS FeedPosted 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. ...
Posted by Michael Wonder on 30 Aug 2017
Abeona Therapeutics receives FDA breakthrough therapy designation for EB-101 autologous cell therapy in epidermolysis bullosa
29 August 2017 - FDA recently guided company to accelerate Phase 3 trial for EB-101 autologous cell therapy. ...
Posted by Michael Wonder on 29 Aug 2017
New drug price questions loom after Gilead's cancer purchase
29 August 2017 - Analysts say Kite’s therapy could reach $500,000 for one dose. ...
Posted by Michael Wonder on 28 Aug 2017
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
28 August 2017 - One of the most promising new fields of science and medicine is the area of cell therapies ...
Posted by Michael Wonder on 23 Aug 2017
Breakthrough cancer drug could be astronomical in price
22 August 2017 - A new leukaemia drug being hailed by doctors as a breakthrough could prove among the most ...
Posted by Michael Wonder on 22 Aug 2017
Novartis CEO opens door to cancer patient demanding ‘fair’ CAR-T pricing
21 August 2017 - David Mitchell had just finished a five-hour infusion of drugs to keep his multiple myeloma under ...
Posted by Michael Wonder on 19 Jul 2017
U.S. FDA designates Mallinckrodt's StrataGraft as regenerative medicine advanced therapy
18 July 2017 - Provides potential for priority review and accelerated approval under 21st Century Cures Act. ...
Posted by Michael Wonder on 13 Jul 2017
CAR-Ts clear one roadblock but face many more
14 July 2017 - Novartis wins over an FDA panel but the road to commercial viability is long. ...
Posted by Michael Wonder on 12 Jul 2017
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat paediatric, young adult r/r B-cell ALL
13 July 2017 - Positive ODAC recommendation is latest milestone for CTL019 program that started through collaboration with the University ...
Posted by Michael Wonder on 11 Jul 2017
First gene therapy — ‘a true living drug’ — on the cusp of FDA approval
11 July 2017 - When doctors saw the report on Bill Ludwig’s bone-marrow biopsy, they thought it was a mistake ...
Posted by Michael Wonder on 11 Jul 2017
What to watch for as Novartis heads to the FDA with a novel cancer therapy
10 July 2017 - The FDA has weighed in on Novartis’ pioneering personalized cancer therapy, which looks almost certain to ...
Posted by Michael Wonder on 08 Jun 2017
Novartis’s next challenge: pricing breakthrough cancer treatment
8 June 2017 - Swiss drugmaker mulls linking cost to results in each patient. ...
Posted by Michael Wonder on 30 May 2017
jCyte receives regenerative medicine advanced therapy designation
2 May 2017 - Cell therapy company jCyte announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...