3
Apr
2018
Tag: Biotech
4
Dec
2017
Bionest
It’s a pill. It’s a device. It’s both. FDA Approves the first Digital Drug Therapy
Adherence to prescription drug therapies is a big problem, not only for patients and drug developers, but also for payers who cover the costs of such medications and then pay to treat problems the drugs were meant to prevent. About 10 years ago, the New England Journal of Medicine estimated that up to two-thirds of...
3
Nov
2017
Bionest
RNA Interference Achieves Key Milestone with Patisiran Success
It is a not uncommon phenomenon for a new discovery to attract much enthusiasm and hype — as well as investment and new company formation — only to suffer popular disillusionment a few years later as public interest turns to the next hot area of science when clinical success remains elusive and far off. After...
17
Oct
2017
Bionest
ESMO 2017 — Part 2: Building on Biomarkers
The news from ESMO in September once again has highlighted the utility and need for biomarkers to help determine not only who will likely benefit from a particular immuno-oncology (IO) treatment, but also who may require a combination of such therapies right from the start. While higher levels of PD-L1 have generally correlated with...
27
Sep
2017
Bionest
New Big Data Initiatives in Oncology
As cancer therapy moves towards the concept of “real-time” oncology — the ability to constantly monitor changes in a patient’s disease and adjust treatment accordingly — we see big data and high powered analytical approaches increasingly playing a key role. The aim of such efforts will be to find novel biomarkers and a new understanding...
20
Sep
2017
Bionest
Advances and Set Backs for CAR-T Therapy
Late August and early September was a period of big news — both positive and negative — on the CAR-T front. On the positive side, Novartis’ received the first FDA approval of a CAR-T therapy for Kymriah (tisagenlecleucel), for the treatment of children and young adults with B-cell precursor acute lymphoblastic leukemia that is refractory...
21
Aug
2017
Bionest
New Developments on the Alzheimer’s Disease Diagnostic Front — Part I
In July, we attended the Alzheimer’s Association International Conference in London. The big news at the meeting was on the diagnostics front. In the aftermath of the recent string of trial failures, diagnostic tools have become a critical area of focus, in the hopes that patient diagnosis and selection can be improved. Accurately diagnosing...
16
Aug
2017
Bionest
Recent Developments in IO – Our Take on a Couple of Key Events
On July 27, AstraZeneca (AZ) disappointed their investors and many immuno-oncology watchers with the results of their MYSTIC trial combining two immunotherapies targeting PD-L1 (durvalumab/Imfinzi) and CTLA-4 (tremelimumab) in newly diagnosed Stage-IV lung cancer patients. The AZ combination therapy failed to show a benefit compared to chemotherapy in a primary endpoint of “Progression-free Survival (PFS).”...
9
Aug
2017
Bionest
Pointed Brexit Warnings from the Pharmaceutical and Biotech Industry
It has now been a year since the United Kingdom voted to leave the European Union. Since then, discussions about the process of achieving Brexit have been fierce — including those affecting the pharmaceutical and biotechnology industries where business is often transnational and drug reviews and approvals have been conducted in a unified manner under...
26
Jul
2017