CAR-T Nears the Marketplace, with Unanimous Approval Recommendation – but Challenges Remain

On July 12, Novartis’ CAR-T therapy, CTL019 (tisagenlecleucel), received a unanimous recommendation for approval from the reviewing U.S. Food and Drug Administration’s advisory panel for use in the treatment of children and young adults with advanced acute lymphoblastic leukemia (ALL)…. Read »

Gene Therapy: Coming of Age Perhaps, but Who Will Pay?

New technologies tend to go through cycles of interest and attention. Initial excitement about the potential of a technological advance too often builds to over-blown hype, followed by a quick reversal of interest in the aftermath of a big disappointment…. Read »

CRISPR Reaches the Clinic

Sometime mid-month, the first clinical trial employing CRISPR gene editing technology within the human body will initiate in China, at Sun-Yat Sen University. Scientists there will seek to use CRISPR and TALEN, another gene editing method, to treat persistent HPV… Read »

FDA: Thinking “Outside the Box”

On May 17, the U.S. Food and Drug Administration granted an expanded approval to Vertex’s Kalydeco (ivacaflor), tripling the number of mutations in the cystic fibrosis (CF)-associated gene CFTR that the drug can treat, from 10 to 33. The agency’s… Read »

Liquid Biopsy – Looking Beyond EGFR

In April, two important reports were published — one in the New England Journal of Medicine, one in Nature — that added evidence in support of liquid biopsy as a means of monitoring for the recurrence of cancer and to… Read »

ASCO 2017 — Some Take-Aways

Several members of the Bionest team attended ASCO this year — the biggest cancer conference in the world, attracting over 30,000 oncology researchers, biopharmaceutical executives, public health experts, investors and journalists.   As we predicted in our pre-ASCO post, one… Read »

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 »

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