Towards a Universal Immuno-oncology Assay Predictive of Drug Response

We have written frequently about the growing importance of biomarkers and how diagnostics will increasingly play a dominant role in the way that therapeutics are prescribed and reimbursed. Immuno-oncology (IO) treatments in particular are expected to benefit from the availability… Read »

Roche Gains Important MS Approval — and Takes Unprecedented Pricing Steps

On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS).  The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for… Read »

FDA Changes the Game: First Cancer Drug Approval Based on Biomarker

The U.S. Food and Drug Administration has issued its first drug approval to a treatment for patients with a specific genetic biomarker, rather than based on an initial tumor location, such as breast cancer. On May 23, the agency granted… Read »

It’s ASCO Time Once Again!

ASCO is the largest annual gathering of the worldwide oncology community, and this year’s event takes place this coming weekend, from June 2-6 in Chicago, Illinois.  About 10 days ago, the association released its program and a wide slate of… Read »

And They’re Off….. Watching the CAR-T Race

On March 29, Novartis announced that the US Food and Drug Administration had accepted the company’s BLA filings for CTL019 (tisagenlecleucel-T) for the treatment of pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Two… Read »

A Look at Duchenne Muscular Dystrophy: Part 3 – The Increasing Activism and Influence of Patient Advocacy Groups

On September 19, 2016 the US Food and Drug Administration approved Sarepta’s Exondys 51 (eteplirsen) injection, the first drug approved to treat the underlying cause of Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a… Read »

A Look at Duchenne Muscular Dystrophy: Part 2 – About DMD, and Approaches to Treatment, Old and New

Duchenne Muscular Dystrophy (DMD) is a rare genetic disease characterized by progressive muscle degeneration and weakness. It is one of the most frequent genetic disorders, affecting approximately 1 of 3,600 (primarily) male children. The disease is caused by a mutation… Read »

A Look at Duchenne Muscular Dystrophy: Part 1 – Marathon Pharmaceuticals, PTC Therapeutics, and Drug Pricing

In February of this year, Marathon Pharmaceuticals received approval for Emflaza (deflazacort) tablets and oral suspension for the treatment of patients over the age of five years with Duchenne muscular dystrophy (DMD), regardless of the particular genetic mutation associated… Read »

Win One/ Lose One: Latest Rulings in the IP Battles Over CRISPR/Cas9

On March 28, the latest round in the intellectual property battle over CRISPR/Cas9 ended with the European Patent Office (EPO) ruling in favor of the University of California / University of Vienna, the work of scientists Jennifer Doudna and Emmanuelle… Read »

Reflecting on AACR

The American Association for Cancer Research annual meeting is always a source of major news and discussion on the oncology research front, and the 2017 meeting held earlier this month was no exception.   One area of particular interest was… Read »

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