Top Regulatory News Stories – Week Ending June 22, 2018

The FDA issued a Complete Response Letter for Valeant’s Duobrii, flagging questions related to the drug’s pharmacokinetics, according to a June 18 statement from the company. https://www.biopharmadive.com/news/valeant-hit-crl-fda-rejection-psoriasis-drug-duobrii/525923/

Shire announced that the FDA has approved a label expansion for CINRYZE® (C1 esterase inhibitor), making it available to help prevent angioedema attacks in children aged 6 years and older with hereditary angioedema (HAE). CINRYZE has been approved in the U.S. since 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE. https://www.firstwordpharma.com/node/1573944?tsid=2

Voyager Therapeutics announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for the VY-AADC gene therapy treatment for Parkinson’s disease in patients with motor fluctuations that are refractory to medical management.  https://www.firstwordpharma.com/node/1574053?tsid=5

Ziopharm’s CAR-T trial was hit with a clinical hold by the FDA which may delay the start of the study: https://endpts.com/ziopharm-gets-hit-with-a-clinical-hold-as-fda-red-lights-human-study-using-their-fast-built-car-t/?utm

Solid Biosciences announced that the FDA removed a Clinical Hold from their SGT-001 trial: https://www.solidbio.com/content/solid-biosciences-announces-fda-removes-clinical-hold-sgt-001

The FDA on Thursday announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic. FDA says it plans to reissue the draft guidance after considering changes to the document that will “promote a more efficient pathway for the development of biosimilar products.”  https://www.raps.org/news-and-articles/news-articles/2018/6/fda-withdraws-guidance-on-biosimilar-analytical-st?utm

The FDA is revising its guidance on the clinical development of treatments for major depressive disorder (MDD). https://www.raps.org/news-and-articles/news-articles/2018/6/major-depressive-disorder-fda-updates-40-year-old?utm

The EMA on Tuesday updated two guidance documents intended to assist drugmakers in their Brexit preparations. https://www.raps.org/news-and-articles/news-articles/2018/6/ema-updates-its-brexit-guidance-for-industry?utm

In other news…

Syneos Health will be reducing operations and laying off 98 employees at its Indianapolis facility amid changing client needs:  https://www.outsourcing-pharma.com/Article/2018/06/12/Syneos-to-lay-off-98-amid-changing-business-needs

Vertex Pharmaceuticals has substantially expanded the San Diego-based research and development facility that discovered its three breakthrough cystic fibrosis (CF) medicines. https://www.biospace.com/article/cf-drugmaker-vertex-more-than-doubles-r-and-d-space-in-san-diego/?utm

New York-based Kallyope and Danish company Novo Nordisk signed a research collaboration and option deal to discover novel therapeutics to treat obesity and diabetes. https://www.biospace.com/article/kallyope-and-novo-nordisk-team-up-to-tackle-obesity/?utm

Six biotech companies had IPOs on Nasdaq this week raising a collective $568 million. This includes Magneta Therapeutics, Avrobio, Aptinyx, Kezar Life Sciences, Xeris Pharmaceuticals and Eidos Therapeutics.  https://endpts.com/five-biotechs-crowd-into-nasdaq-raising-462m-as-the-ipo-party-continues-to-lure-companies-to-wall-street/

 

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