Top Regulatory News Stories – Week Ending September 27, 2019

Bavarian Nordic announces U.S. FDA approval of JYNNEOS™ (Smallpox and Monkeypox Vaccine) for prevention of Smallpox and Monkeypox disease in adults.  https://www.globenewswire.com/news-release/2019/09/24/1920224/0/en/Bavarian-Nordic-Announces-U-S-FDA-Approval-of-JYNNEOS-Smallpox-and-Monkeypox-Vaccine-Live-Non-replicating-for-Prevention-of-Smallpox-and-Monkeypox-Disease-in-Adults.html

Novo Nordisk’s Rybelsus, an oral-semaglutide for type 2 diabetes snagged approval from the U.S. FDA, marking it as the first such treatment to be approved in pill form.    https://www.biospace.com/article/novo-nordisk-snags-fda-approval-for-oral-type-2-diabetes-drug/

Johnson & Johnson’s multiple myeloma drug Darzalex has another FDA nod in previously untreated patients under its belt—and this one is a first for a biologic. https://www.fiercepharma.com/marketing/j-j-s-darzalex-makes-fda-first-expanded-myeloma-nod-new-patients

The FDA approved expanded use of AbbVie’s Mavyret https://seekingalpha.com/news/3502152-fda-oks-expanded-use-abbvies-mavyret

Less than a year after scoring a fast FDA OK for its pioneering acute myeloid leukemia drug gilteritinib, Astellas has snapped up a positive recommendation from European regulators following an accelerated assessment.  https://endpts.com/astellas-aml-drug-wins-over-chmp-strengthening-lead-on-daiichi-sankyo/?utm

Emmaus Life Sciences rescinded its EU marketing application for its sickle cell disease therapy following a negative review by the European regulator. https://endpts.com/emmaus-rescinds-eu-marketing-application-following-negative-review/

Abeona Therapeutics reported that the FDA is slamming the brakes on their Phase III study of EB-101 for rare cases of recessive dystrophic epidermolysis bullosa. https://endpts.com/fda-puts-the-brakes-on-a-rare-disease-biotechs-phiii-as-regulators-wait-for-an-update/

Theraly Fibrosis received an Orphan Drug Designation for TLY012 for Chronic Pancreatitis https://www.biospace.com/article/releases/theraly-fibrosis-granted-us-orphan-drug-designation-for-tly012-for-chronic-pancreatitis/?s=89

Forty Seven, Inc. announced that the FDA has granted Fast Track designation to magrolimab (formerly known as 5F9) for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).  https://www.drugs.com/clinical_trials/forty-seven-inc-granted-fast-track-designation-magrolimab-5f9-myelodysplastic-syndrome-acute-18275.html

Achillion Pharmaceuticals announced that the FDA has granted Breakthrough Therapy designation for danicopan (ACH-4471) for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria (PNH).  https://finance.yahoo.com/news/achillion-receives-breakthrough-therapy-designation-110000996.html

The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Atlanta-based Galt Pharmaceuticals for an email it sent that makes false or misleading claims related to its insomnia treatment Doral (quazepam).  https://www.raps.org/news-and-articles/news-articles/2019/9/fdas-opdp-warns-insomnia-drugmaker-over-email?feed=Regulatory-Focus

The FDA released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020.  https://www.raps.org/news-and-articles/news-articles/2019/9/fda-compiles-list-of-ndas-transitioning-to-blas-ne?feed=Regulatory-Focus

In other news…

BioSpace published their list of 2019 Top 30 Life Sciences Ideal Employers  https://www.biospace.com/article/biospace-announces-the-2019-top-30-life-sciences-ideal-employers-biopharma-companies/?utm

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

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