Phase III
Results Confirm and Extend 40-Week Findings that Treatment with Crysvita is Superior to Conventional Therapy
The pharma giant announced plans to expand its immuno-oncology program with three new Phase III trials following promising data from a combination of Keytruda and Lynparza and other agents.
The American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) is being held in San Francisco from February 14-16. Ahead of the conference, several companies have announced presentations. Here’s a look at just a few.
Gilead Sciences announced that its selonsertib to treat compensated cirrhosis from nonalcoholic steatohepatitis (NASH) did not meet its primary endpoint in the STELLAR-4 Phase III trial. Given Gilead’s expertise in liver diseases, the setback is particularly discouraging.
San Diego-based Arcturus Therapeutics announced it was reassuming 100 percent of its global rights for ARCT-810, a messenger RNA (mRNA) drug to treat OTC Deficiency. The drug previously had a 50/50 collaboration between Arcturus and Tubingen, Germany-based CureVac AG.
On Feb. 12, a U.S. Food and Drug Administration (FDA) advisory committee will debate whether to recommend Johnson & Johnson’s esketamine spray for major depression. It may be an uphill battle, although any positive results in this extremely difficult-to-treat patient population will no doubt be taken into account.
Thomas Wicks, chief strategy officer of New Jersey-based TrialScope, said transparency has picked up over the past few years, particularly as large pharma companies have begun to release information about their own clinical efforts.
Across the globe, pharma companies are making an impact. Last week BioSpace launched the first of a weekly roundup of international biotech and pharma news. Here’s the latest edition.
Shares of Rockville, Md.-based MacroGenics, Inc. have skyrocketed nearly 160 percent in premarket trading after the company announced its Phase III HER2-positive metastatic breast cancer study hit the mark.
Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
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