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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[…]
Most of us associate the term “brand” with companies or sports figures which market their products or personas. The billions of dollars that are invested each year into building and maintaining these brands demonstrates the importance of branding. As an individual, you have a brand as well. There are 3 components to your personal brand[…]
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[…]
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[…]
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,[…]
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The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled the draft guidance documents it plans to publish in 2018, which will include as many as six documents on gene[…]
This was a relatively quiet week for regulatory news. Here is my summary of the top regulatory stories in pharma and biotech: The FDA provided draft guidance regarding a new program which will expand Priority Review Vouchers for medical countermeasure programs including therapeutics and prophylactics for conditions linked with chemical, biological, radiological and nuclear threats,[…]
The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids. https://www.fiercebiotech.com/medtech/fda-clears-boston-scientific-s-electric-pulse-system-for-non-opioid-pain-management Roche said that the EU approved Ocrevus for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis, a form of the neurological disease that previously was without an approved medicine. https://www.reuters.com/article/us-roche-ocrevus/roches-star-ms-medicine-ocrevus-wins-eu-approval-idUSKBN1F10JN[…]
A recurring topic that I discuss with candidates on a daily basis is the pros and cons of making a planned strategic career move. Will this hinder or help their career in the long run? There is a big difference between being a “job hopper” and making strategic career moves. A “job hopper” has made[…]
Happy New Year and I hope you all enjoyed the holidays. Here is my recap of the top regulatory news stories for this week, along with a few notable things that happened during the holiday break… U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than[…]