Blog
RSS FeedPosted by Michael Wonder on 28 Aug 2018
Comparison of two treatment models: precision medicine and preventive medicine
28 August 2018 - In an effort to improve the risk-benefit profile of therapies in clinical care, precision medicine seeks to ...
Posted by Michael Wonder on 28 Aug 2018
Data enclaves for sharing information derived from clinical and administrative data
28 August 2018 - The promise that big data will transform health care has yet to be fulfilled. ...
Posted by Michael Wonder on 28 Aug 2018
Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements
28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...
Posted by Michael Wonder on 28 Aug 2018
You may start seeing drug prices in ads, but will you understand the point?
28 August 2018 - Late last week, the U.S. Senate passed an amendment to the spending bill that would require ...
Posted by Michael Wonder on 28 Aug 2018
Akcea and Ionis receive complete response letter for Waylivra from FDA
27 August 2018 - Akcea Therapeutics today announced that they received a complete response letter from the Division of Metabolism and ...
Posted by Michael Wonder on 28 Aug 2018
Cantex Pharmaceuticals receives FDA fast track designation for CX-01 for the treatment of patients over age 60 with newly diagnosed acute myeloid leukaemia
27 August 2018 - Cantex Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for Cantex's lead product ...
Posted by Michael Wonder on 27 Aug 2018
When medical innovation meets politics
24 August 2018 - FDA Commissioner Scott Gottlieb on the promise and challenges of biologic drugs, capital risk and ‘regulatory arbitrage’ ...
Posted by Michael Wonder on 27 Aug 2018
FDA mandated listing of drug prices in ads would flunk legal and constitutional tests
27 August 2018 - We've read with amusement the recent, overblown claims of some constitutional-law commentators and even U.S. Supreme Court ...
Posted by Michael Wonder on 27 Aug 2018
Tetraphase Pharmaceuticals announces FDA approval of Xerava (eravacycline) for complicated intra-abdominal infection
27 August 2018 - Xerava achieved high clinical cure rates in clinical trials in patients with cIAI. ...
Posted by Michael Wonder on 27 Aug 2018
Amgen submits supplemental new drug application for Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone
27 August 2018 - Filing based on data from Phase 3 head-to-head A.R.R.O.W. study. ...
Posted by Michael Wonder on 27 Aug 2018
AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer
27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval. ...
Posted by Michael Wonder on 26 Aug 2018
FDA approves Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
23 August 2018 - Biacodex is pleased to announce that on 20 August 2018, the FDA has approved Diacomit (stiripentol) for ...
Posted by Michael Wonder on 26 Aug 2018
Krystal Biotechs’ KB105 receives rare paediatric disease designation from the FDA to treat patients with TGM-1-deficient autosomal recessive congenital ichthyosis
23 August 2018 - KB105 is Krystal’s second "off-the-shelf" topical gene therapy candidate to receive rare paediatric disease designation for treating ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
Posted by Michael Wonder on 25 Aug 2018
Ortho Dermatologics receives FDA approval for Altreno (tretinoin 0.05%) lotion for acne
24 August 2018 - Demonstrated tolerability and efficacy of a tretinoin in first and only once daily lotion formulation. ...