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. https://www.businesswire.com/news/home/20180914005613/en/Teva-Announces-U.S.-Approval-AJOVYTM-fremanezumab-vfrm-Injection

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). http://news.ironwoodpharma.com/news-releases/news-release-details/ironwood-pharmaceuticals-announces-fda-fast-track-designation

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. https://www.xconomy.com/boston/2018/09/17/fda-clears-mersana-to-restart-cancer-drug-test-with-new-safeguards/?utm

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.  https://www.firstwordpharma.com/node/1591375

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). https://www.drugs.com/nda/tenapanor_180913.html

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:  http://www.sandiegouniontribune.com/business/biotech/sd-me-acadia-nuplazid-20180920-story.html

Sarepta said today that the EU’s Committee for Medicinal Products for Human Use has rejected eteplirsen for the second time. https://www.xconomy.com/boston/2018/09/21/europe-advisory-panel-rejects-sareptas-duchenne-drug-once-again/

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. https://www.raps.org/news-and-articles/news-articles/2018/9/fda-smashes-record-for-most-anda-complete-response?utm

In other news…

After back-to-back trial flops, Realm Therapeutics is cutting staff and stopping research work.  https://endpts.com/after-back-to-back-trial-flops-realm-slashes-its-staff-halts-research-work-and-ponders-a-fire-sale/?utm

Allergan has agreed to acquire clinical-stage biotech company Bonti in a deal worth more than $195 million: https://www.pharmaceutical-business-review.com/news/allergan-bonti/

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. https://www.statnews.com/2018/09/20/amicus-therapeutics-acquires-portfolio-of-gene-therapies-targeting-neurologic-disorders/?utm_source=STAT+Newsletters&utm_campaign=748b066f0f-MR_COPY_03&utm_medium=email&utm_term=0_8cab1d7961-748b066f0f-149617197

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