Genentech, Inc.
NEWS
When the U.S. Food and Drug Administration approved Genentech’s Xofluza, a single-dose treatment for the flu, it was met with great fanfare, particularly in Japan, where the treatment was first discovered.
Genentech, a Roche company, is flexing its litigation muscle this week. The South San Francisco-based company has filed 18 lawsuits over the past few weeks to block competitors from selling a generic version of a treatment for idiopathic pulmonary fibrosis, a fatal lung-scarring disease.
Movers and Shakers is BioSpace’s weekly roundup of leadership appointments and changes within the biopharma world. Included this week are Genentech, Editas, Sage, Sangamo, and more.
After Bill Anderson moved from the role of Genentech chief executive officer to helm parent company Roche’s division Roche Pharmaceuticals earlier this month, the South San Francisco-based subsidiary has operated without a top executive – until now.
Amgen and Allergan announced positive top-line results from a Phase I/Phase III trial of their biosimilar candidate, ABP 798, to Genentech and Biogen’s Rituxan (rituximab).
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
The U.S. government has been pushing to increase access to experimental drugs over the last two years. On August 18, 2018, the RACE for Children Act was signed into law as part of the 2017 FDA Reauthorization Act, which amended the Pediatric Research Equity Act (PREA).
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
According to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, less than two percent of Americans use biologics, but they account for 40 percent of total spending on prescription drugs.
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