NDA
FDA rejects AstraZeneca diabetes combination
October 16, 2015Research and Development, Sales and Marketing AstraZeneca, FDA, NDA, dapagliflozin, saxagliptin
The FDA has declined to approve AstraZeneca’s New Drug Application (NDA) for the investigational fixed-dose combination of Onglyza and and …
US FDA accepts first digital medicine application
September 11, 2015Medical Communications FDA, NDA, Otsuka, digital, digital medicine, proteus
The FDA has accepted the first New Drug Application for a digital medicine: Otsuka and Proteus Digital Health’s collaboration of …
BMS resubmits hepatitis C drug
March 13, 2015Sales and Marketing BMS, NDA, daclatasvir gilead, hepatitis C, sovaldi
Bristol-Myers Squibb has resubmitted its hepatitis C (HCV) treatment for FDA approval despite previously backing out, as it spots a …
FDA approvals: 1996 versus 2014
January 12, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, John LaMattina, LaMattina, NDA, US, appovals, drugs
As highlighted in a number of recent stories, 2014 was a banner year for the biopharmaceutical industry with 41 new …
GSK submits melanoma drugs for regulatory approval
August 3, 2012Sales and Marketing FDA, GSK, NDA, Zelboraf, melanoma, oncology
GlaxoSmithKline has submitted its two investigational melanoma drugs to regulators in both Europe and the US. The firm is seeking …
Ex-EMA chief ran consultancy firm whilst still in office
December 19, 2011Sales and Marketing EMA, Lonngren, NDA
The former head of the European Medicines Agency Thomas Lonngren set up his own consultancy business to advise pharma whilst …
Graham Higson joins NDA Group to lead Regulatory and HTA Advisory Board
November 4, 2011Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NDA
GE Healthcare and ex AstraZeneca Head of Global Regulatory Affairs, Graham Higson, will join NDA Group in January 2012 to …
European medicines legislation and pharmacovigilance
October 20, 2010Research and Development NDA, pharmacovigilance, regulatory affairs
During the past decade, changes in European medicines legislation and guidelines have increased the scope and regulatory scrutiny of pharmacovigilance …
NDA appoints Dr Panos Tsintis
June 22, 2010Sales and Marketing NDA, appointment, sales and marketing
European regulatory affairs consulting group NDA has appointed Dr Panos Tsintis medical advisor to NDA Regulatory Science in a move …
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