Top Regulatory News Stories – Week Ending January 6, 2018

Happy New Year and I hope you all enjoyed the holidays. Here is my recap of the top regulatory news stories for this week, along with a few notable things that happened during the holiday break…

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the European Union. https://www.usnews.com/news/top-news/articles/2018-01-02/new-drug-approvals-hit-21-year-high-in-2017?src=usn_li

Shire announced that Xiidra® (lifitegrast ophthalmic solution 5%) for the treatment of the signs and symptoms of dry eye disease in adults has been approved in Canada https://globenewswire.com/news-release/2018/01/03/1281454/0/en/Shire-plc-Xiidra-Approved-by-Health-Canada-To-Treat-the-Signs-and-Symptoms-of-Dry-Eye-Disease.html

Novartis’ Kisqali (ribociclib) received Breakthrough Therapy Designation to treat a new segment of premenopausal breast cancer patients. https://www.biospace.com/article/unique-fda-hails-novartis-kisqali-a-breakthrough?utm

Agios reported that it had submitted an application for ivosidenib, a potential drug for patients with acute myeloid leukemia who have a specific genetic mutation, and whose cancer has relapsed or isn’t responding to initial treatment. https://www.bizjournals.com/boston/news/2017/12/26/agios-lines-up-another-potential-fda-nod-with-new.html?

VenatoRx Pharmaceuticals received FDA’s Qualified Infectious Disease Product and Fast Track designations for development of its lead antibiotic program https://www.businesswire.com/news/home/20180103005285/en/VenatoRx-Pharmaceuticals-Receives-FDA%E2%80%99s-QIDP-Fast-Track

The FDA on Wednesday denied Allergan’s third citizen petition attempting to block the agency from approving generic versions of the company’s blockbuster Restasis (cyclosporine ophthalmic emulsion). http://www.raps.org/Regulatory-Focus/News/2018/01/04/29137/FDA-Denies-3rd-Allergan-Citizen-Petition-to-Block-Restasis-Generics/?utm  In a related story, Allergan will be cutting 1400 positions as generic competitors near the market: https://www.fiercepharma.com/pharma/allergan-plots-1k-layoffs-face-restasis-copies

On Wednesday the FDA rejected Agile’s contraception patch for second time https://endpts.com/denied-fda-rejects-agiles-contraception-patch-for-second-time/?

The FDA issued a record low number of OPDP warning letters in 2017 with a total of four during the entire year. http://www.raps.org/Regulatory-Focus/News/2018/01/03/29131/OPDP-Letters-FDA-Closes-Out-2017-With-Record-Low/?utm

The FDA issued new draft guidance last week regarding formal meetings, how to conduct such meetings, and what to expect: http://www.raps.org/Regulatory-Focus/News/2018/01/02/29126/Formal-Meetings-Between-FDA-and-Biopharma-Companies-New-Draft-FDA-Guidance/?utm

The FDA also finalized guidance on the best practices for communications between IND sponsors and FDA. This guidance outlines FDA’s philosophy regarding timely communications with IND sponsors, the scope of appropriate interactions between review teams and IND sponsors, and what kind of advice sponsors can appropriately seek from FDA: http://raps.org/Regulatory-Focus/News/2018/01/02/29124/Best-Practices-for-IND-Sponsor-and-FDA-Communications-FDA-Finalizes-Guidance/?utm

There are five companies awaiting possible approvals from the FDA this month including Lipocine, Aradigm, Synergy, Sucampo and Advanced Accelerator Applications: https://www.biospace.com/article/unique-5-biotechs-awaiting-fda-decisions-in-january-2018-/?utm

In other news…

Mallinckrodt agreed to buy Sucampo Pharmaceuticals for about $1.2 billion in cash to add a treatment for constipation and experimental medicines targeting rare diseases, helping diversify its business away from the controversial drug that makes up the largest part of its revenue. https://www.bloomberg.com/news/articles/2017-12-26/mallinckrodt-to-buy-sucampo-for-about-1-2-billion-in-cash

Arno Therapeutics has sold off all its assets and will be closing its doors: https://www.biospace.com/article/unique-arno-therapeutics-to-shut-down/?utm

Aegerion Pharmaceuticals said that a federal judge’s decision to reject its $40 million plea deal in a drug misbranding case has thrown the company into financial turmoil. https://www.bizjournals.com/boston/news/2017/12/22/aegerion-says-judge-s-rejection-of-40m-plea-clouds.html?

Roche AG is acquiring Ignyta in a $1.7 billion deal that builds out the Swiss pharma’s lung cancer pipeline with a Phase 2 asset. https://www.biopharmadive.com/news/roche-igntya-acquire-deal-lung-cancer/513716/

In an end-of-year IPO blitz, four biotech companies (Armo BioSciences, resTORbio, Menlo Therapeutics and Solid BioSciences) pitched new offerings totaling $370M https://endpts.com/in-an-end-of-year-ipo-blitz-4-biotechs-pitch-new-offerings-totaling-370m/?utm

Scripps Florida is spinning off a company, Expansion Therapeutics. Expansion which is developing drugs that target muscular dystrophy and other diseases announced it has raised $55.3 million in financing. http://www.sun-sentinel.com/business/fl-bz-scripps-company-spinoff-20180103-story.html

Depomed filed notice with the State of California, indicating it planned to lay off 328 staffers starting Feb. 4, 2018 through the end of 2018. https://www.biospace.com/article/unique-the-numbers-are-in-bay-area-s-depomed-reveals-328-job-cuts-in-warn-notice/?utm

OvaScience has decided to implement a corporate restructuring including a reduction in headcount by approximately 50 percent. https://www.businesswire.com/news/home/20180103006219/en/OvaScienceSM-Announces-Corporate-Update

Takeda struck a deal to buy stem cell partner TiGenix for $630 million https://endpts.com/takeda-swoops-in-to-buy-stem-cell-partner-tigenix-for-630m-putting-it-on-threshold-of-a-likely-approval/

In the closing chapter of the merger between INC Research and inVentiv Health, the newly formed CRO has unveiled its new name: Syneos Health https://endpts.com/inc-research-and-inventiv-health-come-under-syneos-health-brand-in-closing-chapter-of-cro-merger/?utm

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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