Top Regulatory News Stories – Week Ending May 17, 2019

The FDA will be launching an expanded access pilot dubbed ‘Project Facilitate’ by End of May.  This program is aimed at improving patient access to unapproved oncology drugs: https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-launch-expanded-access-pilot-project-facil?feed=Regulatory-Focus The FDA has granted Breakthrough Therapy Designation for Sunovion’s schizophrenia drug: http://www.wbjournal.com/article/20190513/NEWS01/190519988 Celgene reported that the FDA has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for[…]

Top Regulatory News Stories – Week Ending May 3, 2019

The U.S. FDA gave Sanofi’s dengue vaccine Dengvaxia a very narrow approval on Wedneday.  The company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.  https://www.reuters.com/article/us-usa-fda-sanofi-fr/sanofi-wins-fda-approval-to-sell-dengue-shot-in-parts-of-u-s-idUSKCN1S74TI?feedType=RSS&feedName=healthNews Finch Therapeutics Group announced that the FDA has granted Fast Track designation to its Full-Spectrum Microbiota® (FSM®)[…]

Top Regulatory News Stories – Week Ending April 26, 2019

Hi folks!  I haven’t done my regulatory news blog in a few months but I’m hoping to make it a regular thing again.  Here are the top regulatory news stories this week: On Tuesday the FDA had approved Abbvie’s Skyrizi (risankizumab-rzaa) for severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.[…]

Top Regulatory News Stories – Week Ending September 7, 2018

Merck announced that the U.S. FDA has approved two new HIV-1 medicines:  DELSTRIGO and PIFELTRO:    https://pharmaphorum.com/news/fda-approves-mercks-hiv-treatment/ Tetraphase Pharmaceuticals announced that the FDA has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). https://ir.tphase.com/news-releases/news-release-details/tetraphase-pharmaceuticals-announces-fda-approval-xeravatm Bayer announced that the FDA approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of[…]

Top Regulatory News Stories – Week Ending August 10, 2018

The FDA approved Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of two rare types of non-Hodgkin lymphoma: relapsed or refractory mycosis fungoides and Sézary syndrome.  https://markets.businessinsider.com/news/stocks/kyowa-kirin-announces-fda-approval-of-poteligeo-mogamulizumab-kpkc-for-the-treatment-of-mycosis-fungoides-and-s%C3%A9zary-syndrome-1027443628 An FDA Advisory Committee has recommended approval of Paratek’s Omadacycline for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia:[…]

Top Regulatory News Stories – Week Ending August 3, 2018

Shionogi & Co announced that, after completing a Priority Review, the FDA has approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin  receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease. https://www.marketwatch.com/press-release/shionogi-announces-fda-approval-of-mulpleta-lusutrombopag-2018-08-01 Indivior PLC announced that the FDA has approved PERSERIS™, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for[…]

Top Regulatory News Stories – Week Ending July 27, 2018

AbbVie received FDA approval for elagolix, the first new oral drug approved for endometriosis pain in more than a decade.  The drug will be rolled out into the marketplace under the name Orilissa.  https://endpts.com/following-some-clean-sweeps-in-phiii-abbvie-gets-an-fda-ok-on-its-top-10-blockbuster-prospect-orilissa/?utm The FDA approved the 12th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible indications[…]

5 Simple Ways to Show Appreciation

What’s your reaction when you hear a 5-time Super Bowl winning quarterback state he feels everyone could be more appreciated?  Part of it depends on whether you’re a Patriots fan, but let’s take that out of the equation. As an employer, it hit me like a ton of bricks because Tom Brady is one of[…]

Top Regulatory News Stories – Week Ending April 27, 2018

The FDA has approved Helsinn’s intravenous formulation of AKYNZEO® (a fixed antiemetic combination of fosnetupitant and palonosetron) as an alternative treatment option for patients experiencing Chemotherapy Induced Nausea and Vomiting.  Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014. https://www.helsinn.com/news-and-events/helsinn-group-announces-the-fda-approval-of-the-iv-formulation-of-akynzeo-fosnetupitant-palonosetron-in-the-united-states/ Catalyst Pharmaceuticals announced its submission of a NDA[…]

How Leaders Are Empowered by Adversity

Every day we have challenges, some are bigger, some are smaller, and some get to the point where they almost break us, where we feel we can’t take anymore. And yet, that’s where we can experience a fork in the road – one is to crumble and do nothing and the other is to plow[…]