Top Regulatory News Stories – Week Ending December 14, 2018

Novartis’ Sandoz unit and Pear Therapeutics announced Monday that the FDA cleared their prescription-only mobile medical app, reSET-O, marking the first FDA-cleared prescription digital therapeutic for patients with opioid use disorder.

Stealth BioTherapeutics announced that the FDA has granted Fast Track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy.

The FDA has declined to approve an abuse-deterrent version of Mallinckrodt’s opioid painkiller Roxicodone, saying some parts of the company’s application need further evaluation.

The FDA has placed a partial hold on MacroGenics monotherapy cancer trials due to concerns of liver toxicity:

BioXcel Therapeutics announced that the FDA has accepted its IND application for lead neuroscience candidate, BXCL501.

FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.

In other news…

What started as an antitrust lawsuit brought by states over just two drugs in 2016 has exploded into an investigation of alleged price-fixing involving at least 16 companies and 300 generic drugs:

Another Axovant program, nelotanserin, missed its primary endpoint and will be scrapped:

Pfizer will add about 100 new jobs in oncology research and development at its La Jolla, California site, as its Cancer Immunology Discovery unit relocates out of South San Francisco and the company eliminates 100 roles there.

AMAG Pharmaceuticals will acquire privately-held Perosphere Inc. to leverage its expertise in hematology.


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