Top Regulatory News Stories – Week Ending April 20, 2018

Rigel Pharmaceuticals announced that the FDA approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.  https://www.prnewswire.com/news-releases/rigel-announces-fda-approval-of-tavalisse-fostamatinib-disodium-hexahydrate-for-chronic-immune-thrombocytopenia-itp-in-adult-patients-300631702.html Ultragenyx and Kyowa Kirin announced FDA approval of Crysvita® (burosumab-twza) for the treatment of children and adults with X–Linked Hypophosphatemia  http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-kyowa-kirin-announce-fda-approval-crysvitar[…]

Top Regulatory News Stories – Week Ending April 13, 2018

This was a relatively busy week with new draft guidances, new orphan drug designations, two supplemental approvals, and the lifting of a clinical hold.  Here are the top regulatory stories for this week: The Food and Drug Administration has approved the first artificial intelligence software that can decide, without a clinician’s involvement, whether a patient[…]

Top Regulatory News Stories – Week Ending April 6, 2018

This week saw the submission of two new NDAs, two complete response letters, and one refusal to file.  Here are the top regulatory news stories for this week: Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461, a once-daily, oral investigational medicine with a novel[…]

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[…]