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Bristol Myers Squibb (BMS) has filed a complaint in federal court alleging AstraZeneca’s cancer therapy Imjudo (tremelimumab) infringes on its blockbuster immunotherapy drug Yervoy (ipilimumab). Read More
Merck’s KEYNOTE trials of its mega-blockbuster cancer drug Keytruda (pembrolizumab) had mixed results this week, failing in another bid for prostate cancer but hitting the mark with biliary tract cancer. Read More
The FDA’s Antimicrobial Drugs Advisory Committee gave a 14-1 thumbs-up yesterday for Cidara Therapeutics’ rezafungin, an investigational injection intended to treat candidemia and invasive candidiasis in adults who have no other treatment options. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has concluded that its proposed quality management maturity (QMM) scoring system is “too complex,” based on findings from two pilot programs. Read More
At the request of sponsor Biogen, the FDA has extended by three months the new drug application review period for tofersen, an investigational treatment for SOD1 amyotrophic lateral sclerosis — a very rare genetically induced form of the fatal disease. Read More
The FDA will keep in place its regulations on orphan drug exclusivity rather than altering them in response to a pivotal U.S. appeals court ruling. Read More
The most likely cost-effectiveness estimates for the Ninlaro treatment combination is below $38,000 per quality-adjusted life-year, NICE said. Read More
The company will pay for six doses if treatment had been discontinued because the patient still had low platelet counts after four days of combined treatment with Cablivi, plasma exchange and immunosuppressive therapy. Read More