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

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

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