Vertex Under Fire

The Institute for Clinical & Economic Review (ICER) recently ruled that all three of Vertex’s cystic fibrosis (CF) drugs are considerably overpriced. ICER analyzed the prices for Kalydeco, Orkambi, and new treatment Symdeko based on a metric called “quality-adjusted life… Read »

The First Cannabis-Derived Drug Heads for FDA Approval

A new treatment for two particularly severe forms of epilepsy is on track to become the first cannabis-derived drug to gain approval from the U.S. Food and Drug Administration (FDA). On April 19, an FDA advisory panel unanimously recommended the… Read »

Hot Topics in Neurology at AAN

We have been thinking for some time about the importance of biomarkers in both drug discovery and clinical medicine as they relate to Alzheimer’s (and our In Vivo publication also addresses this topic in depth). At the recent American Academy… Read »

Anticipating ASCO

We always greatly anticipate the scientific and educational sessions presented at the American Society of Clinical Oncology (ASCO) annual meeting, this year being held in Chicago from June 1-5. The meeting is the largest of its kind focused on cancer,… Read »

New Gains in Frontline Non-Small Cell Lung Cancer

Each spring, those of us who watch the oncology space turn our attention to two big U.S. meetings for the latest research news: the American Association of Cancer Research (AACR) annual scientific meeting, held in April, and the American Society… Read »

BIO2018, here we come: Real-time oncology and biomarkers for Alzheimer’s disease

The BIO International Convention is a huge gathering each year, as around 15-18,000 representatives from across industry and around the world get together to discuss policy, partnering, and product development over the course of four days. This year’s event, to… Read »

New Contender in Race to Develop Allogeneic CAR-T Treatments

Just months after negotiating the sale of autologous CAR-T pioneer Kite Pharma to Gilead for $11.9 billion, two of the executives who led Kite to success are back with a new company, a clinical-stage asset, and a portfolio of 16… Read »

Update on FDA’s Patient Benefit-Risk Assessment Program

Over the past several years, the U.S. Food and Drug Administration has begun efforts to further incorporate patient perspective on benefits and risks of potential new treatments in their regulatory reviews and to bring additional transparency and communication to the… Read »

FDA Decision on Dexcom Device Changes Playing Field for Continuous Glucose Monitoring

At the end of March, the U.S. Food and Drug Administration approved a new continuous glucose monitor (CGM) system, the Dexcom G6. The new sensor is smaller than current CGM devices, about the size of a quarter. It comes already… Read »

Moving from Exploratory Collaborations to Record-Setting Deals in IO

In early March, we wrote about the collaboration between Bristol-Myers Squibb and Nektar aimed at developing Nektar’s T-cell stimulating molecule NKTR-214 in combination with BMS’s checkpoint inhibitor Opdivo (nivolumab). That deal brought Nektar an eye-opening $1.85 billion in upfront cash… Read »

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