17
Jul
2017
Tag: strategy
12
Jul
2017
Bionest
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 infection and disable the tumor growth mechanism in infected cells. In a non-invasive approach, scientists...
5
Jul
2017
Bionest
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 action was unusual in that, for the first time ever, they based their decision on...
26
Jun
2017
Bionest
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 predict a patient’s response to adjuvant therapy. Both studies were based on data from the...
20
Jun
2017
Bionest
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 of the biggest take-aways from the conference was the continued and ever-growing emphasis on combination...
14
Jun
2017
Bionest
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 of truly predictive biomarkers, based on the dramatic treatment gains they have achieved for a...
6
Jun
2017
Bionest
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 the treatment of PPMS, a form of the disease that accounts for 10-15% of MS...
26
May
2017
Bionest
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 abstracts that have given way to plenty of media reports and speculation about what other...
23
May
2017
Bionest
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 days later, Kite Pharma announced that they had completed the rolling submission for their own...
16
May
2017