Top Regulatory News Stories – Week Ending April 6, 2018

This week saw the submission of two new NDAs, two complete response letters, and one refusal to file.  Here are the top regulatory news stories for this week:

Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder: https://www.prnewswire.com/news-releases/alkermes-receives-refusal-to-file-letter-from-fda-for-alks-5461-300622455.html

Celltrion has received complete response letters from the FDA for two biologics license applications for rituximab and trastuzumab biosimilars https://endpts.com/celltrion-receives-crls-for-rituxan-herceptin-biosimilars/

Sunovion Pharmaceuticals announced it submitted a NDA to the FDA for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease. https://www.biospace.com/article/sunovion-submits-nda-for-sublingual-parkinson-s-treatment/?utm

Catalyst Pharmaceuticals has submitted a NDA to the FDA for Firdapse, a treatment for a rare degenerative neuromuscular disease.  https://www.bizjournals.com/southflorida/news/2018/03/29/catalyst-files-new-drug-application-with-fda.html?ana=RSS&s=article_search

Sancilio Pharmaceuticals announced that the European Commission has granted Orphan Designation to Altemia, a novel oral formulation being developed for the treatment of SCD in pediatric patients.  http://www.firstwordpharma.com/node/1553749#axzz5BiI2Cwai

The FDA granted Proteostasis Therapeutics’ triple combination for cystic fibrosis Fast Track Designation. https://www.biospace.com/article/proteostasis-stock-surges-on-fast-track-designation/?utm

The FDA expanded the use of Amgen’s leukemia drug Blincyto to include patients who are in remission but still have residual signs of the disease.  https://www.reuters.com/article/us-fda-amgen-blincyto/fda-expands-use-of-amgen-leukemia-drug-blincyto-to-patients-with-relapse-risk-idUSKBN1H52OD

Allergan and partner Gedeon Richter plan to file an sNDA for Vraylar (cariprazine) based upon positive Phase III data for biopolar 1 disorder.  Vraylar was previously approved for schizophrenia and manic episodes.  https://endpts.com/allergan-richter-prep-for-fda-ok-with-positive-phiii-for-cariprazine-in-bipolar-depression/?utm

The FDA finalized a revised draft guidance from 2015 on the unique aspects and the types of information sponsors should submit for NDAs and ANDAs for liposome drug products.  https://www.raps.org/news-and-articles/news-articles/2018/4/fda-finalizes-guidance-on-liposome-drugs?utm

In other news…

New biotech company Allogene Therapeutics has raised $300 million in cash financing and inked a partnership with Pfizer’s CAR-T portfolio. https://endpts.com/arie-belldegrun-raises-300m-grabs-pfizers-allogeneic-car-t-portfolio-and-launches-a-groundbreaking-drive-to-commercialization/?utm

Roche has committed to a $25 million investment in Versant while also grabbing their star MS drug: https://endpts.com/roche-grabs-a-remyelination-ms-drug-from-versant-as-the-research-team-spins-out-into-a-25m-regenerative-med-startup/?utm

Ferring Pharmaceuticals is acquiring Rebiotix  along with their PhIII microbiome drug https://endpts.com/ferring-buys-up-phiii-microbiome-drug-with-acquisition-of-rebiotix/

Startup Macrolide Pharmaceuticals raised $20 million in a Series B round from three pharma giants, including the venture arms of GlaxoSmithKline (SR One), Novartis (Novartis Venture Fund), and Roche (Roche Ventures), among other investors. https://endpts.com/backed-by-giants-antibiotics-upstart-macrolide-gets-20m-and-an-ex-novartis-exec-as-ceo/?utm

Shares of Shire have surged based upon Takeda’s interest in a possible takeover.  https://endpts.com/with-a-deadline-looming-takeda-woos-analysts-for-support-of-a-shire-buyout/

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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