Newsletter - June 30, 2016
Brexit Will Not Have a Major Affect on Drug Approvals in UK and Europe
It has been a week since UK voted to leave the European Union. There have been rampant speculations on what this decision means for the drug industry. Dooms day scenarios painted by a several commentators would have us believe that most work by regulators in UK and the EU would be negatively affected. But a careful review of the existing processes and practical aspects of Brexit shows that it may not change much for the drug industry. Read More..
Cancer Drug Developers Get More Help in FDA’s New “Oncology Center of Excellence”
In his State of the Union address this year, President Obama announced the “Cancer Moonshot” of the US government whereby multiple aggressive initiatives were launched to find cures for cancer. Over the last six months, numerous initiatives have been announced to encourage research, increase patient participation in clinical trials, and expedite the approval of new cancer drugs. Most new cancer drugs are eligible for the 6-month priority review and most of the breakthrough designations have been for cancer drugs. Read More..
Brexit Will Not Have a Major Affect on Drug Approvals in UK and Europe
It has been a week since UK voted to leave the European Union. There have been rampant speculations on what this decision means for the drug industry. Dooms day scenarios painted by a several commentators would have us believe that most work by regulators in UK and the EU would be negatively affected. But a careful review of the existing processes and practical aspects of Brexit shows that it may not change much for the drug industry. Read More..
Cancer Drug Developers Get More Help in FDA’s New “Oncology Center of Excellence”
In his State of the Union address this year, President Obama announced the “Cancer Moonshot” of the US government whereby multiple aggressive initiatives were launched to find cures for cancer. Over the last six months, numerous initiatives have been announced to encourage research, increase patient participation in clinical trials, and expedite the approval of new cancer drugs. Most new cancer drugs are eligible for the 6-month priority review and most of the breakthrough designations have been for cancer drugs. Read More..
