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The FDA finalized a revised draft guidance from 2015 on the unique aspects and the types of information sponsors should submit for NDAs and ANDAs for liposome drug products.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