Top Regulatory News Stories – Week Ending September 21, 2018

Teva announced U.S. FDA approval of AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.

Ironwood Pharmaceuticals announced that the FDA has granted Fast Track Designation for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

The FDA has cleared Mersana Therapeutics to resume enrolling patients in a study of an experimental cancer drug now that the company is taking new precautions to protect patients from potential harm.

Cytori Therapeutics announced that it received FDA orphan drug designation for its ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, for the treatment of small cell lung cancer.

Ardelyx, Inc. announced the submission of its NDA to the FDA for Tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C).

On Thursday the FDA said that Nuplazid, a Parkinson’s disease drug from Acadia Pharmaceuticals, provides more benefits than risks and has no new safety concerns:

Sarepta said today that the EU’s Committee for Medicinal Products for Human Use has rejected eteplirsen for the second time.

The FDA has issued more complete responses for abbreviated new drug applications (ANDAs) in 2018 than any other year, and the numbers are not even close.

In other news…

After back-to-back trial flops, Realm Therapeutics is cutting staff and stopping research work.

Allergan has agreed to acquire clinical-stage biotech company Bonti in a deal worth more than $195 million:

Amicus Therapeutics is expanding the focus its drug development work with the purchase of a portfolio of early-stage gene therapies targeting rare neurologic diseases.

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