We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A New York district judge has once again thrown out a whistleblower complaint alleging that Novartis offered doctors kickbacks to entice them to prescribe its multiple sclerosis blockbuster Gilenya (fingolimod). Read More
The investigational treatment also received Fast Track designation from the FDA in August for the treatment of patients with pulmonary sarcoidosis. Read More
New generic drug approvals in 2018, 2019 and 2020 yielded $53.3 billion in savings, according to a new FDA report that analyzed results from 2,400 approved new generic drug applications. Read More
The day a bench trial was slated to begin in Delaware federal court on Gilead’s five patent disputes with generic drug makers who were poised and ready to make copies of Gilead’s two HIV blockbuster drugs and its hepatitis B drug, the company announced that it had settled the disputes. Read More
All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of barriers, according to a panel discussion held at the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix this week. Read More
Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More
Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of the Regulatory Affairs Professional Society (RAPS) taking place in Phoenix this week. Read More
Novartis has posted positive late-stage results for people with advanced liver cancer this week, while Amgen’s trial on a form of non-small cell lung cancer (NSCLC) caused by a genetic mutation also produced hopeful outcomes. So did a Novartis trial focused on a painful skin condition. Read More
The National Institutes of Health (NIH) has begun enrolling adults and children in a phase 3 clinical trial to test the effectiveness of the smallpox antiviral TPOXX (tecovirimat) on monkeypox. Read More