Top Regulatory News Stories – Week Ending December 7, 2018

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.

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.

The FDA on Monday issued draft guidance on developing drugs to treat patients who have noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

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).

Oncobiologics has changed its name to Outlook Therapeutics and also announced their next steps in their corporate strategy:

Biopharma Dive has named Spark Therapeutics as their “Biotech of the Year”  and Merck as “Pharma of the Year”

Moderna’s IPO raised over $600 million, one of the biggest initial public offerings for a biotech company:


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