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RSS FeedPosted by Michael Wonder on 14 Jul 2017
FDA grants fast track designation to VT-1598 for treatment of Valley fever
13 July 2017 - Viamet Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to VT-1598, a ...
Posted by Michael Wonder on 14 Jul 2017
Sangamo receives fast track designation from the FDA for SB-318 and SB-913 in vivo genome editing product candidates for the treatment of MPS I and MPS II
13 July 2017 - Sangamo Therapeutics announced today that the U.S. FDA has granted fast track designation to SB-318 and SB-913, ...
Posted by Michael Wonder on 14 Jul 2017
Janssen announces U.S. FDA approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis
13 July 2017 - Tremfya is the first and only biologic approved that selectively blocks interleukin 23. ...
Posted by Michael Wonder on 13 Jul 2017
Amgen and Allergan to discuss data supporting biologics license application for ABP 215, a biosimilar candidate to Avastin (bevacizumab)
13 July 2017 - First Amgen and Allergan oncology biosimilar candidate to be reviewed by U.S. FDA Advisory Committee ...
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 13 Jul 2017
House poised to pass bill critical for drug industry; the Senate may be a slog
12 July 2017 - The House of Representatives is fast-tracking a vote on a key priority for the pharmaceutical industry, ...
Posted by Michael Wonder on 13 Jul 2017
Senators explore bipartisan ‘Plan B’ to troubled GOP health bill
12 July 2017 - Some senators seek instead to shore up Obamacare markets. ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 13 Jul 2017
ICER releases draft evidence report reviewing olaparib, rucaparib, and niraparib for ovarian cancer
12 July 2017 - Public comment period now open until 9 August; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 12 Jul 2017
Targeting unconscionable prescription-drug prices — Maryland’s anti–price-gouging law
12 July 2017 - Why, in the early 21st century, are so many drugs that were cheaply available in the 20th ...
Posted by Michael Wonder on 12 Jul 2017
The economics of indication-based drug pricing
12 July 2017 - Contrary to the hopes of its supporters, indication-based drug pricing will result in higher prices for patients ...
Posted by Michael Wonder on 12 Jul 2017
Novartis price dilemma over $21,000 drug
12 July 2017 - Novartis recently discovered that a drug it sells for a group of very rare diseases could ...
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 12 Jul 2017
Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA
11 July 2017 - No efficacy or safety issues raised by FDA. ...
Posted by Michael Wonder on 12 Jul 2017
New US health care plan to be unveiled
12 July 2017 - The top US Senate Republican will unveil a revised version of major healthcare legislation sought by ...