Top Regulatory News Stories – Week Ending December 1, 2017

Hi folks, I’m publishing my blog a day early since I will be out of the office tomorrow.  Here are the top regulatory news stories for this week:

Scott Gottlieb, the commissioner of the Food and Drug Administration, announced plans to speed generic versions of treatments that combine a drug and a device: https://www.forbes.com/sites/matthewherper/2017/11/28/fda-boss-aims-to-close-epipen-loophole/#4af7e7fe39f9

According to a new report from Public Citizen’s Congress Watch, the FDA has withdrawn 26 regulations related to medical products so far in 2017: https://endpts.com/major-deregulation-fda-withdraws-several-rules-and-regulations-related-to-medical-products/?utm_medium=email&utm

Biohaven Pharmaceuticals announced that they received agreement from the FDA on the initial pediatric study plan (iPSP) for orally-dosed rimegepant. http://markets.businessinsider.com/news/stocks/Biohaven-Receives-Agreement-From-FDA-on-Initial-Pediatric-Study-Plan-for-Rimegepant-a-Second-Generation-Oral-CGRP-Receptor-Antagonist-for-the-Acute-Treatment-of-Migraine-1008768195

The FDA has approved Kaleo’s sNDA for Auvi-Q (epinephrine injection, USP) for life-threatening allergic reactions in infants and small children. Auvi-Q was first approved in August 2012:  https://www.drugs.com/newdrugs/fda-approves-kal-o-s-auvi-q-epinephrine-usp-0-1-mg-auto-injector-threatening-allergic-reactions-4645.html

Based upon a recent FDA meeting, KemPharm Inc. said it remains on track to submit its ADHD prodrug KP415 for approval as early as the end of 2018:  https://www.biopharmadive.com/news/kempharm-eyes-2018-filing-for-adhd-drug/511205/

PellePharm secured Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for its topical drug patidegib for Gorlin Syndrome, a rare genetic disease. http://www.businesswire.com/news/home/20171120005310/en/FDA-Grants-Breakthrough-Therapy-Designation-Orphan-Drug

Tremeau Pharmaceuticals announced today that the FDA has granted an Orphan Drug Designation for TRM-201 (rofecoxib) for the treatment of hemophilic arthropathy (HA) https://www.drugs.com/clinical_trials/fda-grants-orphan-designation-trm-201-rofecoxib-hemophilic-arthropathy-17653.html?

Orpheris Inc. reported that the FDA has granted Orphan Drug Designation to OP-101 for the treatment of patients with childhood cerebral andrenoleukodystrophy (ccALD) https://www.firstwordpharma.com/node/1525353

Amherst Pharmaceuticals and Magna Pharmaceuticals received a warning letter from the OPDP for making “false or misleading” claims on a website and at a trade show about their Zolpimist insomnia treatment. The letter also included a reprimand for failing to submit the proper FDA labeling form as required before promoting the drug. https://www.fiercepharma.com/marketing/not-over-till-it-s-over-pharma-ad-police-send-out-another-warning-letter?

BioMarin announced that it has sold another Rare Pediatric Disease Priority Review Voucher (PRV) for $125 million, but they did not disclose who purchased the voucher. https://www.biopharmadive.com/news/biomarin-sells-priority-review-voucher/511659/

 As 2017 comes to a close, the FDA face a busy December with nine companies awaiting decisions: https://www.biospace.com/article/unique-9-biotechs-facing-fda-decisions-in-december/?utm

In other news…

Quartet Medicine, a biotech company founded in 2013, is closing its doors by the end of this year:  https://www.biospace.com/article/unique-cambridge-biotech-quartet-medicine-to-shut-down-by-year-end?utm

Teva Pharmaceuticals is expected to cut thousands of jobs in the US and Israel in the coming weeks:  https://www.reuters.com/article/us-teva-pharm-ind-redundancies/teva-pharmaceutical-set-for-major-layoffs-in-israel-u-s-report-idUSKBN1DN0TC

Fresenius Kabi says they will invest $100 million in eastern North Carolina and create hundreds of new jobs as it expands its current production facility and prepares to build a new onsite manufacturing center. https://www.biospace.com/article/unique-fresenius-kabi-to-expand-pharmaceutical-manufacturing-in-north-carolina?utm

Denali Therapeutics, which is developing treatments for neurodegenerative diseases, announced terms for its $150 million IPO http://www.nasdaq.com/article/denali-therapeutics-sets-terms-for-150-million-ipo-cm882407

Colorado-based Clovis Oncology has solidified its physical footprint in the Bay Area with a new 10 year lease on a 32,000 square foot space in Oakland: https://www.biospace.com/article/unique-clovis-expands-bay-area-footprint-with-huge-lease-in-oakland/?utm

Otonomy announced a strategy to refocus its pipeline developmental programs, divest one of its products, and reduce the company’s headcount to about 50 employees:  https://www.biospace.com/article/unique-troubled-otonomy-cuts-jobs-ceases-programs-related-to-otiprio/?utm

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