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RSS FeedPosted by Michael Wonder on 17 Aug 2018
Eisai and Merck announce FDA approval of Lenvima (lenvatinib) capsules for first-line treatment of unresectable hepatocellular carcinoma
16 August 2018 - Approval was based on REFLECT, the first-ever positive Phase 3 trial against an active comparator in previously ...
Posted by Michael Wonder on 17 Aug 2018
Health Canada proposes ‘pause the clock’ mechanism for pre-market submissions
15 August 2018 - Health Canada recently released for consultation a plan to establish a mechanism that allows for the ...
Posted by Michael Wonder on 17 Aug 2018
Sun Pharma announces U.S. FDA approval of Cequa to treat dry eye disease
16 August 2018 - Cequa (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye ...
Posted by Michael Wonder on 16 Aug 2018
How disruptive innovation by business and technology firms could improve population health
16 August 2018 - In 1990 the Centers for Disease Control and the US Preventive Services Task Force launched Healthy ...
Posted by Michael Wonder on 16 Aug 2018
European drug agency loses 30% of staff in planned move to Amsterdam
16 August 2018 - The EMA is counting the cost of the UK’s decision to leave the European Union, which ...
Posted by Michael Wonder on 16 Aug 2018
Statement from FDA Commissioner on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
16 August 2018 - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves first generic version of EpiPen
16 August 2018 - The U.S. FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for ...
Posted by Michael Wonder on 16 Aug 2018
Ortho Dermatologics resubmits U.S. new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
15 August 2018 - Ortho Dermatologics, a division of Bausch Health, today announced it has resubmitted a new drug application to ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves Kalydeco (ivacaftor) as first and only medicine to treat the underlying cause of CF in children ages 12 to <24 months with certain mutations in the CFTR gene
15 August 2018 - Data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages 12 to <24 months. ...
Posted by Michael Wonder on 15 Aug 2018
FDA recalls are a reminder that China controls much of world's drug supply
15 August 2018 - "If we were ever in an international incident with China, they would literally have their hands around ...
Posted by Michael Wonder on 15 Aug 2018
EMA scales back transparency initiatives because of workload
14 August 2018 - The European Medicines Agency has scaled back its landmark clinical trial data policies, the drug regulator ...
Posted by Michael Wonder on 15 Aug 2018
FDA advances efficient approaches to designing and conducting cancer clinical trials
14 August 2018 - Over the past decade, advances in understanding of cancer biology have led to the development of targeted ...
Posted by Michael Wonder on 15 Aug 2018
Galderma Canada announces new indication for Dysport Aesthetic
14 August 2018 - Galderma Canada is pleased to announce that Health Canada has approved Dysport Aesthetic (abobotulinumtoxinA) for the temporary ...
Posted by Michael Wonder on 14 Aug 2018
Five predictions for AI and real world data in oncology
14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...
Posted by Michael Wonder on 14 Aug 2018
Motif Bio announces FDA acceptance of new drug application with priority review for iclaprim for treatment of acute bacterial skin and skin structure infections
14 August 2018 - PDUFA action date set for 13 February 2019. ...