Blog
RSS FeedPosted by Michael Wonder on 22 Nov 2017
The promise and challenges of CAR-T gene therapy
22 November 2017 - The recent approvals of 2 one-time gene therapies for refractory paediatric acute lymphoblastic leukaemia and adult relapsed ...
Posted by Michael Wonder on 22 Nov 2017
Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015
22 November 2017 - Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. ...
Posted by Michael Wonder on 22 Nov 2017
Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
22 November 2017 - Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardise the generalisability of results, and limit ...
Posted by Michael Wonder on 22 Nov 2017
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
22 November 2017 - FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, which can make small adjustments ...
Posted by Michael Wonder on 22 Nov 2017
Institute for Clinical and Economic Review report finds evidence limited on treatments for tardive dyskinesia; discounts of up to 90% needed to align cost of drugs with benefit to patient
21 November 2017 - Report will be subject to public deliberation during New England CEPAC meeting on 5 December 2017. ...
Posted by Michael Wonder on 22 Nov 2017
U.S. FDA accepts regulatory submission and grants priority review for US WorldMeds' lofexidine
21 November 2017 - US WorldMeds today announced that the U.S. FDA has accepted and granted priority review of the ...
Posted by Michael Wonder on 21 Nov 2017
NDA submission for VivaGel BV in the US
21 November 2017 - Starpharma today announced that its US new drug application submission for VivaGel BV for both treatment ...
Posted 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 21 Nov 2017
Statement from FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
21 November 2017 - FDA issues guidance on development of generic abuse-deterrent opioids. ...
Posted by Michael Wonder on 21 Nov 2017
Fighting cancer one patient at a time
21 November 2017 - Allan Brandt, a 63-year-old history of medicine professor at Harvard, seems taken aback to have become part ...
Posted by Michael Wonder on 21 Nov 2017
FDA approves first two-drug regimen for certain patients with HIV
21 November 2017 - FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with ...
Posted by Michael Wonder on 21 Nov 2017
Janssen submits application to U.S. FDA to expand indication for Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
21 November 2017 - Supplemental biologics license application seeks first indication for Darzalex for the treatment of newly diagnosed patients. ...
Posted by Michael Wonder on 21 Nov 2017
Roche sues Pfizer to block biosimilar of cancer drug Herceptin
21 November 2017 - Company seeks to protect drug that earned $2.5 billion. ...
Posted by Michael Wonder on 21 Nov 2017
FDA grants breakthrough therapy designation and orphan drug designation to PellePharm for topical patidegib in Gorlin syndrome
20 November 2017 - PellePharm today announced that the U.S. FDA has granted both breakthrough therapy designation and orphan drug ...
Posted by Michael Wonder on 20 Nov 2017
Intra-Cellular Therapies receives FDA fast track designation for lumateperone for the treatment of schizophrenia
20 November 2017 - Intra-Cellular Therapies today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation ...