Clinical trials in the United States have been plagued for years by two well-known problems: They don’t recruit enough people and they fail to reflect the diversity of our nation. The good news is that solving the diversity problem can…
Genentech’s Satralizumab Shows Strong Results in Rare CNS Disorder
Genentech, a Roche company, released full data from its pivotal Phase III SAkuraStar trial of satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD). The company presented the data at the 35th Congress of the European Committee for Treatment…
Speaker Pelosi Circulates Working Plan to Lower 250 Drug Prices in US
Pharma stock prices took an across-the-board tumble Tuesday after Speaker of the House Nancy Pelosi unveiled a working plan to lower the prices of 250 of the most expensive drugs covered by Medicare and other government-funded programs. In some…
Lilly’s $8 Billion Bet Pays Off With Dazzling Results in Lung Cancer Trial
When Eli Lilly and Company acquired Loxo Oncology for $8 billion, the company was gambling on several pipeline drugs in oncology. One was Vitrakvi (larotrectinib), which was approved by the U.S. Food and Drug Administration and is commercialized by Bayer.…
Consider Patients’ Attitudes When Designing Benefit-Risk Communications
Effectively communicating a trial’s benefits and risks to prospective subjects requires an understanding of how different types of patients process information. Trials with high benefit and low risk clearly are easiest to communicate to patients. At the other end of…
Preparing for Success: A Better Way to Manage the Feasibility Process
The site selection and feasibility process is really quite straightforward on paper. And yet it is astonishingly hard. Here are some numbers that prove the point: 11 percent of sites selected never enroll a single patient; Sponsors’ original timelines end…
Poll: Should Companies Be Allowed to Sue Other Companies to Prevent Generic Competition?
Recently, after running an article about Novo Nordisk’s lawsuit against generic drug maker Mylan, BioSpace ran a mini-poll, asking, “Should companies be allowed to sue other companies to prevent generic versions of drugs?” The topic often rises to the top…
