Top Regulatory News Stories – Week Ending February 9, 2018

The FDA on Wednesday approved Biktarvy, Gilead Sciences’s once-daily, triple-combination tablet for treatment of HIV infection

Spectrum Pharmaceuticals plans to file a BLA for approval of its chemotherapy side effect drug Rolontis later this year based upon positive results from a Phase 3 study

Zogenix has won the FDA’s breakthrough therapy designation for its Dravet syndrome drug ZX008

Lysogene announced that the Paediatric Committee (PDCO) of the EMA adopted a positive opinion regarding the company’s Paediatric Investigation Plan for its lead product candidate LYS-SAF302 in patients with mucopolysaccharidosis type IIIA.

AMAG Pharmaceuticals announced that the FDA has approved its sNDA application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.

The FDA granted Breakthrough Therapy status for Sage Therapeutics’ SAGE-217 for Major Depressive Disorder:

Verastem has filed for approval of duvelisib, a pill that blocks the well-known cancer target PI3 kinases and they expect to hear from FDA in early 2019.

With a second set of phase 3 data in hand for smallpox vaccine Imvamune, Bavarian Nordic is gearing up for a U.S. filing later this year.

In other news…

J&J has agreed to pay $100 million in cash to launch a partnership with Theravance on the pan-JAK inhibitor TD-1473 for a treatment for inflammatory bowel disease

Enumeral Biomedical has filed for bankruptcy protection and is selling its assets to Xoma Corporation for $1.6 million.

Roivant Sciences and ArQule, Inc. announced the initiation of a collaboration to pursue the development of derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor in China.

Arbutus Biopharma announced it was initiating an organizational restructuring that includes the termination of 31 percent of its global workforce and the shutdown of its British Columbia site.

Lonza Pharma & Biotech and Denali Therapeutics announced an exclusive strategic partnership on Denali’s biologic pipeline products for neurodegenerative diseases.

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