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The plaintiffs allege that Gilead and other companies used anticompetitive tactics to keep prices artificially high for their respective HIV treatments.
Purdue, Bristol-Myers Squibb and Apotex have been singled out in opioid-related lawsuits in Canada.
The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
The panel opposed approval of Daiichi Sankyo’s AML drug but supported approval for its TGCT treatment.
Teijin Limited announced today that it has signed a research and development agreement with the Japan Agency for Medical Research and Development (AMED) to form an industry-government-academia partnership that will explore preventive and therapeutic drugs for frail elderly people as designated under AMED’s Cyclic Innovation for Clinical Empowerment program(CiCLE) in October 2018.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
The new guidance should allow switches from branded products to biosimilars that are alike in safety and efficacy without prescriber approval.
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