FDA Issues Set of Guidelines on Gene Therapy

Back in December, the U.S. Food and Drug Administration (FDA) granted its first approval for a gene therapy product, Spark Therapeutics’ Luxturna. According to the Alliance for Regenerative Medicine, as many as 50 more such treatments — addressing a diverse… Read »

As Brexit Approaches, Concerns about Impacts Abound

On March 29, 2019, the United Kingdom is scheduled to leave the European Union (EU). Since the UK passed the referendum in 2016 to leave the economic bloc, there have been plenty of uncertainties on how this will affect not… Read »

The Drug Pricing Blueprint — and Audience Reactions

In May of this year, the Trump White House issued its “Blueprint to Lower Drug Prices” in response to the Administration’s views that excessively high drug prices “burdening the American people” were in part caused by “foreign freeloading” and a… Read »

Steps Toward the Use of Real World Evidence

“Real-world evidence” (RWE) is data on the use and accrued long-term benefits/risks of a drug or device that is gathered outside of a clinical trial — generally after the product has been approved. Clinical trials don’t often reflect the breadth… Read »

Drug Pricing and Pharma

In September 2015, Martin Shkreli, then CEO of Turing Pharmaceuticals, sparked widespread outrage in the United States when the company raised prices on an off-patent treatment for toxoplasmosis, Daraprim, by over 5,000%, just one month after Turing acquired the drug…. Read »

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 »

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