Top Regulatory News Stories – Week Ending October 6, 2017

After a very busy month of approvals and rejections in September, this week has been relatively quiet. Here are the top regulatory news stories for pharma and biotech this week:

According to the latest FY 2017 activities report, the US FDA has approved more abbreviated new drug application (ANDA) in 2017 than any other year:

Mylan said the U.S. FDA has approved two doses of its generic version of Teva’s Copaxone used to treat patients with relapsing forms of multiple sclerosis.

Stealth BioTherapeutics announced that FDA’s Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with primary mitochondrial myopathy (PMM).

The FDA granted Breakthrough Therapy to Acadia Pharmaceutical’s dementia-related psychosis drug Nuplazid (pimavanserin).

Palladio Biosciences announced that the FDA has granted orphan drug designation to lixivaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

In other news…

Ultragenyx and Dimension Therapeutics announced that they have entered into a definitive merger agreement under which Ultragenyx will acquire all of the outstanding shares of common stock of Dimension for $6.00 per share, or approximately $151 million in cash.  This was significantly higher than Regenxbio’s agreed offer for Dimension in August.

Celgene has secured an option on two preclinical assets in development at Nimbus Therapeutics.

 Intra-Cellular Therapies raised its target of $150 million from a new public offering that will help it prepare for an FDA filing for lead drug lumateperone in schizophrenia next year.

Amgen has entered into a deal with CytomX Therapeutics to use the CytomX Probody platform to craft treatments for multiple kinds of cancer.

Bayer and J&J say their big PhIII secondary stroke trial for Xarelto failed:


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