FDA Approves Merck Tumor Treatment for DNA-Linked Cancers

In a move towards general cancer treatment, the FDA has approved Merck’s cancer drug for the treatment of any advanced tumor with microsatellite instability or DNA mismatch repair defects. Variants of these DNA indicators are present in genetically-linked cancers. The...

Bayer Granted Fast Track Approval from FDA for Cancer Drug

Bayer Pharmaceuticals announced this week that its cancer drug, Copanlisib, has been granted priority review by the FDA. The expedited process means that Bayer will know within 6 months whether Copanlisib has been granted regulatory approval versus the standard 10...
How the eCTD has Changed Submission Teams

How the eCTD has Changed Submission Teams

New Age Regulatory Operations: How the eCTD has Changed Submission Teams How the eCTD has Changed Submission Teams   In May of this year, regulatory operations leaders will finally begin preparing therapy submissions under one standardized format. The eCTD’s...
How One Company is Redefining Scientific Exchange

How One Company is Redefining Scientific Exchange

Digital Medical Affairs How One Company is Redefining Scientific Exchange How One Company is Redefining Scientific Exchange   Scientific exchange is an integral part of the pre-launch phase for medical affairs. Traditionally, this information is deployed to...

Building the Pre-Launch Road-Map

Building the Pre-Launch Road-Map Expert Tips for Navigating the Pre-Launch Phase Expert Tips for Navigating the Pre-Launch Phase       Evolving complexities and increased scrutiny of the pharmaceutical industry have dictated a heavy reliance on early...