Top Regulatory News Stories – Week Ending February 16, 2018

This week was saw the approval of two new molecular entities by the FDA while Apricus received a Complete Response Letter.  Here is my recap of the top regulatory news stories for this week…   Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor and ivacaftor) has been approved by the FDA to treat the underlying cause of cystic fibrosis[…]

Top Regulatory News Stories – Week Ending February 9, 2018

The FDA on Wednesday approved Biktarvy, Gilead Sciences’s once-daily, triple-combination tablet for treatment of HIV infection https://www.reuters.com/article/us-gilead-sciences-fda/u-s-fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ? Spectrum Pharmaceuticals plans to file a BLA for approval of its chemotherapy side effect drug Rolontis later this year based upon positive results from a Phase 3 study https://www.biopharmadive.com/news/spectrum-advances-neutropenia-drug-toward-fda-filing/516408/ Zogenix has won the FDA’s breakthrough therapy designation for[…]

Top Regulatory News Stories – Week Ending February 2, 2018

This week saw a rejection by the FDA for Aradigm, a clinical hold for Bellicum, and a black box warning for Intercept.  In addition, the FDA granted a Breakthrough Therapy designation along with a Fast Track designation. Here are the top regulatory stories for the week: The FDA has rejected Aradigm’s inhaled antibiotic Linhaliq and[…]

Reflections on Leadership

  The amazing part about leadership is that you can challenge yourself to grow and be better every day. And you can do that easily by leading by example. I am so grateful to work with an amazing group of people.  As their employer, I have a responsibility to provide them with stability, encouragement, growth,[…]

Top Regulatory News Stories – Week Ending January 26, 2018

Here is my regulatory news blog for this week… Advanced Accelerator Applications received US FDA Approval for LUTATHERA® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors  https://www.reuters.com/article/us-advanced-accelerator-fda/fda-approves-drug-for-rare-cancer-that-killed-steve-jobs-idUSKBN1FF29K The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled the draft guidance documents it plans to publish in 2018, which will include as many as six documents on gene[…]