26
Jul
2017
Tag: clinical trials
17
Jul
2017
Bionest
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. But if continued research later produces truly encouraging results, interest can build again as time...
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...
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...
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...
7
Mar
2017
Bionest
Alzheimer’s Disease: Part One – Another One Bites the Dust
Alzheimer’s Disease: Part One – Another one bites the dust, but a possible glimmer of hope on the horizon On February 14, Merck halted the Phase 3 trial of its Alzheimer’s disease drug candidate, verubecestat, after independent analysis showed that the drug had “virtually no chance of working.” This late stage failure was just the...
29
Sep
2016
Bionest
Blue Ribbon Panel Issues Cancer Moonshot Recommendations
On September 7, a Blue Ribbon Panel — composed of 28 top cancer researchers, oncologists, patient advocates and leaders from the private sector — issued 10 recommendations aimed at speeding up advances in cancer prevention, diagnosis, treatment and care. The panel was created as part of the Cancer Moonshot first announced in January of this...
16
Aug
2016