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[…]

Top Regulatory News Stories – Week Ending March 30, 2018

Hey folks, I’m posting this a day early since I will be taking off for a long weekend.  Here are the top regulatory news stories for this week: The EMA’s Committee for Medicinal Products for Human Use (CHMP) rejected two drugs where were approved by US FDA in 2017 (betrixaban and abaloparatide):    https://www.raps.org/news-and-articles/news-articles/2018/3/ema%E2%80%99s-chmp-rejects-two-drugs-approved-by-us-fda-in GSK’s Shingrix[…]

Top Regulatory News Stories – Week Ending March 2, 2018

This week the FDA approved two new products and announced a new pilot program for orphan drug designations.  Celgene received a Refusal to File letter and Allergan’s PDUFA date was delayed. And the EMA provided more details regarding their new premises in Amsterdam.  Here are the top regulatory news stories for this week: KemPharm announced[…]

The Power of Communication

When you communicate with someone, what are you thinking about?  Are you thinking about what you want to say or the impact you want to have?  You may feel confident about your message, but will the delivery be received in the manner intended?  Have you considered who your audience is – employees, managers, friends, or[…]