Ocular Therapeutix announced that the FDA has approved DEXTENZA (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. https://www.biospace.com/article/releases/ocular-therapeutix-announces-fda-approval-of-dextenza-for-the-treatment-of-ocular-pain-following-ophthalmic-surgery/?s=89
Roche’s checkpoint inhibitor Tecentriq got approval Thursday from the FDA in the first-line setting to treat non-squamous non-small cell lung cancer in combination with Avastin and chemotherapy. https://www.biopharmadive.com/news/roches-tecentriq-gets-first-line-lung-cancer-approval/543869/
The FDA on Monday issued draft guidance on developing drugs to treat patients who have noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. https://endpts.com/fda-issues-draft-guidance-on-nash-drug-development/?utm
In other news…
GlaxoSmithKline announced Monday an agreement to acquire Tesaro for around $5.1 billion in cash, gaining the latter’s oral PARP inhibitor Zejula (niraparib). https://www.firstwordpharma.com/node/1608638
Oncobiologics has changed its name to Outlook Therapeutics and also announced their next steps in their corporate strategy: https://www.nasdaq.com/press-release/oncobiologics-changes-name-to-outlook-therapeutics-announces-next-steps-in-executing-ons5010-20181203-00678
Biopharma Dive has named Spark Therapeutics as their “Biotech of the Year” https://www.biopharmadive.com/news/dive-awards-biotech-of-the-year-spark-gene-therapy/539622/ and Merck as “Pharma of the Year” https://www.biopharmadive.com/news/dive-awards-pharma-of-the-year-merck/539651/
Moderna’s IPO raised over $600 million, one of the biggest initial public offerings for a biotech company: https://www.wsj.com/articles/highly-anticipated-moderna-listing-is-seen-as-test-of-new-ipos-1544092200
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