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 the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma. https://www.biospace.com/article/releases/celgene-corporation-announces-pomalyst-granted-breakthrough-therapy-designation-from-fda-for-hiv-positive-and-negative-kaposi-sarcoma/?s=89

Transgene announced that it has received IND clearance from the FDA to proceed with a Phase 1 clinical trial of its lead myvac™ candidate TG4050 as a potential treatment for ovarian cancer patients after first-line surgery and chemotherapy.  https://www.biospace.com/article/releases/transgene-receives-fda-ind-clearance-for-lead-myvac-individualized-immunotherapy-tg4050-to-commence-clinical-development-in-ovarian-cancer/?s=89

Esperion announced today that the FDA has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review.  https://www.drugs.com/nda/bempedoic_acid_190505.html

ERYTECH Pharma announced the acceptance by the FDA of its IND application to initiate enrollment at US trial sites for its ongoing pivotal Phase 3 TRYbeCA1 trial evaluating eryaspase in second-line pancreatic cancer. https://www.globenewswire.com/news-release/2019/05/13/1822896/0/en/ERYTECH-Announces-FDA-s-Authorization-to-Proceed-with-Phase-3-Trial-for-Eryaspase-in-Pancreatic-Cancer-in-the-United-States.html

In other news…

Essa Pharma is set to acquire Realm Therapeutics in an all-stock deal:  https://www.fiercebiotech.com/biotech/essa-strikes-deal-to-buy-realm-gaining-cash-to-fund-cancer-r-d

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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