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:

According to a new report from Public Citizen’s Congress Watch, the FDA has withdrawn 26 regulations related to medical products so far in 2017:

Biohaven Pharmaceuticals announced that they received agreement from the FDA on the initial pediatric study plan (iPSP) for orally-dosed rimegepant.

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:

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:

PellePharm secured Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for its topical drug patidegib for Gorlin Syndrome, a rare genetic disease.

Tremeau Pharmaceuticals announced today that the FDA has granted an Orphan Drug Designation for TRM-201 (rofecoxib) for the treatment of hemophilic arthropathy (HA)

Orpheris Inc. reported that the FDA has granted Orphan Drug Designation to OP-101 for the treatment of patients with childhood cerebral andrenoleukodystrophy (ccALD)

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.

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.

 As 2017 comes to a close, the FDA face a busy December with nine companies awaiting decisions:

In other news…

Quartet Medicine, a biotech company founded in 2013, is closing its doors by the end of this year:

Teva Pharmaceuticals is expected to cut thousands of jobs in the US and Israel in the coming weeks:

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.

Denali Therapeutics, which is developing treatments for neurodegenerative diseases, announced terms for its $150 million IPO

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:

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:

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