Regulatory Roundup: Top News Stories – Week Ending May 5, 2017


This has been another exciting week with a flurry of regulatory activity in pharma and biotech.

The FDA approved Radius Health’s drug TYMLOS to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies.  However, this included a “black box” warning that the treatment had increased the risk of bone cancer in rats. This is the first commercial program for Radius and it will compete against Eli Lilly’s FORTEO treatment. You can find the full story here.

AstraZeneca gained FDA approval for durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma — one of the most common forms of bladder cancer.  The treatment was approved six weeks ahead of its goal date through the accelerated approval process. AstraZeneca will be required to complete ongoing clinical trials to confirm the effectiveness of the drug which will be sold under the brand name IMFINZI. The full article can be found here.

Aeterna Zentaris’ endometrial cancer drug fails in phase 3 study. I t failed to demonstrate a statistically significant increase in the median period of overall survival of patients.  Based on this outcome, the company does not anticipate conducting clinical trials of the drug for other indications. The full article can be found here.

Sunesis withdrew its leukemia drug marketing application in Europe after learning that the EMA was likely to report a negative evaluation.  Full story here

Citing data from an animal study, the FDA has asked Intra-Cellular Therapies for new information about the safety of long-term use of its experimental schizophrenia drug, lumateperone. You can find the full story here.

 The FDA is establishing a new “Digital Health” unit within the CDRH.  Digital health includes categories such as mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. You can find the full story here.

 Some interesting price tags:  On the heels of last week’s announcement about BioMarin’s new $700,000 treatment, Endpoints News published their list of the 10 most expensive drugs on the planet:  The full article can be found here.

In IPO news, Ovid Therapeutics raised $75 million in an IPO late Thursday, becoming the fifth life sciences company to hit the Nasdaq in the past two weeks.  The full article can be found here.

This is a weekly recap of selected news stories. You can read other additional blogs, see our recent job postings and learn more about us at