Roche wins speedy FDA review for Tecentriq; South Korean authorities to look into Samsung BioLogics accounting practices
→ Trailing behind immunotherapy offerings from Merck $MRK and Bristol-Myers Squibb $BMY, Roche $RHHBY has been plotting to secure approval of its Tecentriq for difficult-to-treat cancers. On Tuesday, the Swiss drugmaker announced the FDA had agreed to an accelerated review of Tecentriq in combination with the chemotherapy Abraxane for initial treatment of metastatic triple-negative breast cancer with tumors that test positive for the protein PD-L1. The priority review designation means the FDA is expected to make a decision on the drug by March 12, 2019, Roche said.
→ After announcing plans in August to make a big push into biopharmaceuticals over the next three years, Samsung’s long-term foray into health may be in trouble. South Korean regulators are set to review allegations of accounting fraud at the tech giant’s biotech arm on Wednesday, amid concerns that the authorities could delist the firm following claims that Samsung BioLogics violated accounting rules three years ago, Nikkei reported.
→ India’s InvaGen is absorbing New York-based Avenue Therapeutics $ATXI into its specialty pharmacy business. The acquisition will take place in two phases: InvaGen is first committing to buying a third of the company for $35 million, and sending three representatives to the board. Once the closing conditions are met — involving FDA approval, labeling, scheduling and other regulatory decisions regarding the IV pain med Tramadol it’s developing — the companies will close the second stage, which they say will be worth up to $180 million.