Positive Results Reported in Alzheimer’s Disease — But Questions Remain

In early July, Biogen and Eisai announced that analysis of their 18-month Phase 2 trial of BAN2401 revealed encouraging results, showing an effect on both lowering of amyloid levels and slowing of cognitive decline in patients treated with the highest… Read »

New Options for Diabetes Therapy on the Horizon

Research presented in June at the American Diabetes Association (ADA) meeting highlighted potential advances for diabetes patients who use drugs in a class called incretin mimetics –specifically GLP-1 (glucagon-like peptide 1) agonists — to help control their blood sugar. Such… Read »

Biotech Companies Flock to Newly Liberalized Hong Kong Stock Exchange

The Stock Exchange of Hong Kong Limited (The Exchange) adopted new rules on April 30 that for the first time enable pre-revenue companies in “emerging and innovative sectors” — including biotechnology — to submit formal applications to list on that… Read »

Analysts’ Predictions on Top 10 Best Selling Drugs in 2024 — And Our Take

Market analyst firm Evaluate released their annual report, “EvaluatePharma World Preview 2018: Outlook to 2024,” last month. The report predicts that worldwide prescription drug sales will grow to over $1.2 trillion over the next six years. Novartis is projected to… Read »

A New ‘Neulasta’: First Biosimilar Version Gains FDA Approval

In early June, the U.S. Food and Drug Administration (FDA) approved the first biosimilar version of Amgen’s Neulasta (pegfilgrastim), a biologic that is used to reduce the chances of infection in cancer patients whose immune system have been suppressed by… Read »

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 »

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