Regulatory Roundup: Top News Stories – Week Ending September 29, 2017

The FDA approved Eli Lilly’s Verzenio (abemaciclib) to treat adult patients who breast cancer that has progressed following prior treatment: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm

Allergan received a refuse-to-file letter from the FDA for its sNDA to add an additional indication to its already-approved drug Vraylar (cariprazine). http://www.biopharmadive.com/news/allergan-hit-with-fda-refusal-to-file-letter/505726/

Janssen received a complete response letter from the FDA for its rheumatoid arthritis candidate sirukumab.  In its rejection letter, the FDA requested additional clinical data so as to re-evaluate the safety of the drug in this indication. http://www.biopharmadive.com/news/following-negative-adcomm-jjs-sirukumab-rejected/505720/

Intarcia Therapeutics reported that the FDA has rejected its type 2 diabetes drug-device combo ITCA 650, sending the Boston-based company a complete response letter. http://www.biopharmadive.com/news/intarcia-fda-rejection-crl-diabetes-device-combo/506030/

Based on FDA feedback at a recent guidance meeting, Novan says it will need to conduct a new pivotal study to support a U.S. marketing application for topical gel acne candidate SB204.  https://seekingalpha.com/news/3297406-fda-wants-new-clinical-trial-support-lead-candidate-sb204-shares-2-percent

Dova Pharmaceuticals announced the submission of a NDA to the FDA for avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA) for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure. https://globenewswire.com/news-release/2017/09/22/1131460/0/en/Dova-Pharmaceuticals-Announces-New-Drug-Application-Submission-to-FDA-for-Avatrombopag-a-Second-Generation-Thrombopoietin-Receptor-Agonist.html

Cascadian Therapeutics announced that the FDA has granted orphan drug designation to tucatinib for the treatment of HER2-positive (HER2+) metastatic colorectal cancer. https://www.drugs.com/clinical_trials/cascadian-therapeutics-announces-fda-orphan-designation-granted-tucatinib-her2-metastatic-17621.html

Audentes Therapeutics reported that the FDA has granted Rare Pediatric Disease and Fast Track designations for AT132, the company’s gene therapy product candidate being developed to treat X-Linked Myotubular Myopathy (XLMTM). https://www.firstwordpharma.com/node/1508798

La Jolla Pharmaceutical Company announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC-501 (angiotensin II) for the treatment of hypotension in adults with distributive or vasodilatory shock. Based on this advice, La Jolla intends to submit a MAA for LJPC-501 in the third quarter of 2018. http://www.businesswire.com/news/home/20170925005341/en/La-Jolla-Pharmaceutical-Company-Announces-Intent-Submit

In other news…

Cambridge cancer drug startup Cue Biopharma is eying a $40 million IPO eight months after its launch:  https://www.bizjournals.com/boston/news/2017/09/25/cambridge-cancer-drug-startup-eyes-40m-ipo-eight.html

Genocea Biosciences says it is shelving work on its lead, Phase III-ready program for genital herpes and is putting it up for auction.  In addition they are cutting 40% of its staff and refocusing the company towards Immuno-oncology and the development of neoantigen cancer vaccines.  https://globenewswire.com/news-release/2017/09/25/1132366/0/en/Genocea-Announces-Strategic-Shift-to-Immuno-oncology-and-the-Development-of-Neoantigen-Cancer-Vaccines.html

Axovant’s experimental Alzheimer’s drug, intepirdine, failed to halt patients’ declines in cognition or improve their ability to function in daily life in a large phase 3 clinical trial. https://www.statnews.com/2017/09/26/axovant-intepirdine-trial/

 Aegerion Pharmaceuticals has finalized a $40 million settlement to resolve civil and criminal charges over its marketing of a cholesterol drug. https://www.bizjournals.com/boston/news/2017/09/22/aegerion-finalizes-40m-settlement-guilty-plea-in.html

Pfizer has spun off four investigational drugs into a new medicines company dubbed SpringWorks Therapeutics. http://clinicaltrials.pharmaceutical-business-review.com/news/pfizer-spins-off-new-company-with-four-rare-disease-therapies-260917-5934483

Mateon Therapeutics announced Wednesday morning that it has halted its lead clinical trial due to lack of efficacy. http://www.biopharmadive.com/news/mateon-shuts-down-lead-trial-due-to-bad-data/505930/

Nightstar Therapeutics, a clinical-stage gene therapy company developing treatments for rare inherited retinal diseases, announced the pricing of its initial public offering https://www.firstwordpharma.com/node/1508864

AbbVie and Amgen have agreed to a deal in which Amgen won’t start selling Amjevita, a cheaper alternative to Abbvie’s blockbuster drug Humira, in the U.S. until 2023. All litigation between the two firms over the drugs also will be dropped. https://www.axios.com/drug-company-settlement-delays-humira-competition-2490536187.html

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

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