Precision Medicine and NGS Cancer Panels — ASCO Round-Up Part Two

As we wrote in our last post, precision medicine in oncology was the big theme of this year’s ASCO meeting. One of the key advances that has made possible this focus on treating cancer based on particular biomarkers expressed by… Read »

A Few Takeaways from ASCO 2018 — Part One

Precision medicine was an important theme of ASCO 2018 — the annual meeting of the American Society of Clinical Oncology — with this year’s meeting subtitled as “Delivering Discoveries, Expanding the Reach of Precision Medicine.”  This theme was reflected not… Read »

First Up For The New FDA RMAT Designation: Gene Therapeutics for Hemophilia

We recently wrote about the U.S. Food and Drug Administration’s (FDA) creation of a Regenerative Medicine Advanced Therapy (RMAT) designation in an effort to speed up the approval process for certain types of treatments, including gene therapies. The agency has… Read »

Creating a New Global Pharmaceutical Giant: Takeda to Acquire Shire

The fifth try was the charm for Takeda Pharmaceuticals. On May 8, Takeda announced that their fifth offer to acquire Shire Pharmaceuticals had been accepted, subject to regulatory and shareholder approvals. This is the largest deal yet in 2018, and the largest… Read »

Embryonic Stem Cell Technology and FDA

Stem cell research has elicited both excitement and controversy since its earliest days. Hematopoietic stem cell transplants have been employed for some time in the treatment of certain blood cancers. More recently, researchers have reported clinical successes in using bone… Read »

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 »

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