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[…]

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:[…]

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[…]

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[…]

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[…]

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[…]

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[…]