Top Regulatory News Stories – Week Ending May 24, 2018

Hi folks, I am publishing my blog a day early due to the holiday weekend.  Here are the top regulatory stories for this week:

On Monday Dova Pharmaceuticals announced the FDA completed their Priority Review and approved DOPTELET (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure: https://globenewswire.com/news-release/2018/05/21/1509548/0/en/Dova-Pharmaceuticals-Announces-U-S-FDA-Approval-of-DOPTELET-avatrombopag.html

bluebird bio, Inc. announced that the FDA has granted Breakthrough Therapy designation to Lenti-D™ for the treatment of patients with cerebral adrenoleukodystrophy, a rare hereditary neurological disorder. http://investor.bluebirdbio.com/news-releases/news-release-details/fda-grants-breakthrough-therapy-designation-lenti-dtm-treatment

Glenmark Pharmaceuticals has submitted a NDA to the FDA for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.  https://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-announces-the-companys-first-new-drug-application-for-ryaltris-for-patients-with-seasonal-allergic-rhinitis-300651988.html

BERG, LLC announced that the FDA has granted orphan-drug designation for their lead product candidate, BPM 31510 (ubidecarenone), for the treatment of patients with Epidermolysis Bullosa, a rare, pervasive and debilitating connective tissue disorder.  http://www.firstwordpharma.com/node/1567546#axzz5GQjnxqM9

In addition to new draft guidance documents on gene therapy-related issues, the FDA says it will also release guidance on the clinical development of gene and cell therapies: https://www.raps.org/news-and-articles/news-articles/2018/5/gottlieb-fda-prepping-for-push-of-new-gene-and-ce?feed=Regulatory-Focus

The US House of Representatives passed a “Right to Try” bill which would allow terminally ill patients to try experimental treatments outside of the FDA purview: https://www.raps.org/news-and-articles/news-articles/2018/5/house-passes-bill-allowing-terminally-ill-to-ask-c?utm

In other news…

Takeda aims to save $1.4 billion by the end of the three years after the Shire acquisition closes and expects to cut 6% to 7% of the combined workforce, about 3,600 employees. https://www.fiercebiotech.com/biotech/takeda-to-cut-moderately-innovative-r-d-after-62b-shire-buy-reuters?mkt

Astellas plans to cut 600+ jobs as part of a company overhaul: https://endpts.com/astellas-shedding-600-plus-jobs-as-ceo-shakes-up-rd-and-sales-ops-in-restructuring/?utm

Allergan has acquired an investigational NMDA depression drug discovered by Aptinyx and plans to pair it with its rapastinel depression therapy currently under development.  https://www.fiercebiotech.com/biotech/allergan-acquires-nmda-depression-drug-from-aptinyx-collaboration

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/