Top Regulatory News Stories – Week Ending September 13, 2019

Five years after securing its first approval in idiopathic lung fibrosis,  Boehringer Ingelheim’s drug Ofev has been cleared to slow the rate of pulmonary decline in patients with another lung scarring disease. https://endpts.com/boehringer-ingelheims-ofev-wins-fda-approval-for-use-in-scleroderma-patients/

Ridgeback Biotherapeutics announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation. https://www.prnewswire.com/news-releases/ridgeback-biotherapeutics-lp-announces-receipt-of-breakthrough-therapy-designation-from-fda-for-mab114-300913398.html

Acceleron Pharma Inc. announced that the FDA has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH). https://www.businesswire.com/news/home/20190909005250/en/Acceleron-Receives-FDA-Orphan-Drug-Designation-Sotatercept/?

The FDA has granted Orphan Drug Status to BioXcel Therapeutics’ BXCL701 as potential treatment for AML https://immuno-oncologynews.com/2019/09/11/fda-grants-orphan-drug-status-bioxcels-bxcl701-potential-aml-treatment/

Omeros Corporation announced that FDA agreed with the company’s proposed schedule for the rolling review of the BLA for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).  https://www.businesswire.com/news/home/20190911005310/en/FDA-Confirms-Omeros’-Schedule-Rolling-Review-Company’s/?

The FDA has placed a clinical hold on one of Amgen’s early-stage cancer drugs:  https://endpts.com/fda-slaps-a-hold-on-one-of-amgens-early-stage-cancer-drugs-raising-cardiac-tox-concerns-for-a-top-prospect-in-the-pipeline/

In other news…

Aclaris Therapeutics will lay off 86 employees and end certain development programs as it restructures to extend cash for operations. https://www.biopharmadive.com/news/aclaris-to-lay-off-86-employees-in-restructuring-to-extend-cash/562312/

Zafgen is seeking alternatives including an acquisition, merger, business combination, in-licensing, or another strategic transaction involving the company or its assets.  https://endpts.com/a-battered-zafgen-seeks-strategic-options-prophesying-ongoing-study-will-unlikely-lift-fda-hold-on-diabetes-drug/

GlaxoSmithKline will acquire San Diego-based Sitari Pharmaceuticals and its transglutaminase 2 small molecule program for celiac disease.  https://www.biospace.com/article/gsk-snaps-up-celiac-focused-sitari-pharmaceuticals/

Purdue Pharma has tentatively settled thousands of opioid cases with states and local governments:  https://www.nytimes.com/2019/09/11/health/purdue-pharma-opioids-settlement.html

Castle Creek is buying gene and cell therapy company Fibrocell for a reported $63 million:  https://endpts.com/from-partner-to-knight-in-shining-armor-castle-creek-to-buy-fibrocell/

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