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RSS FeedPosted by Michael Wonder on 29 Nov 2017
Is the FDA withholding data about a controversial drug to protect its manufacturer?
29 November 2017 - In the case of Sarepta, it sure looks that way. ...
Posted by Michael Wonder on 29 Nov 2017
BioMarin sells second priority review voucher for 125 million dollars
27 November 2017 - BioMarin today announced that it has entered into a definitive agreement to sell the rare paediatric disease ...
Posted by Michael Wonder on 28 Nov 2017
Dova Pharmaceuticals announces FDA acceptance of the avatrombopag new drug application with priority review
27 November 2017 - Dova Pharmaceuticals today announced the new drug application for avatrombopag has been accepted for filing and has ...
Posted by Michael Wonder on 28 Nov 2017
Stealth BioTherapeutics granted fast track designation for the treatment of Barth syndrome
27 November 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead ...
Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products. ...
Posted by Michael Wonder on 23 Nov 2017
Alkermes’ new drug application for investigational product designed for initiation onto Aristada accepted for filing by U.S. FDA
16 November 2017 - FDA action expected by 30 June 2018. ...
Posted by Michael Wonder on 23 Nov 2017
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
23 November 2017 - GlaxoSmithKline and Innoviva today announced the filing of a supplemental new drug application with the US FDA ...
Posted 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
Mendelian randomisation
21 November 2017 - Mendelian randomisation uses genetic variants to determine whether an observational association between a risk factor and an ...
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 ...