Tag: FDA

29
May 2018

Bionest

The First Cannabis-Derived Drug Heads for FDA Approval

A new treatment for two particularly severe forms of epilepsy is on track to become the first cannabis-derived drug to gain approval from the U.S. Food and Drug Administration (FDA). On April 19, an FDA advisory panel unanimously recommended the approval of Epidiolex (cannabidiol, also known as CBD), under development by British pharmaceutical company GW...
30
Apr 2018

Bionest

Update on FDA’s Patient Benefit-Risk Assessment Program

Over the past several years, the U.S. Food and Drug Administration has begun efforts to further incorporate patient perspective on benefits and risks of potential new treatments in their regulatory reviews and to bring additional transparency and communication to the deliberation that goes into regulatory decisions. The agency has been responding to an increased awareness...
24
Apr 2018

Bionest

FDA Decision on Dexcom Device Changes Playing Field for Continuous Glucose Monitoring

At the end of March, the U.S. Food and Drug Administration approved a new continuous glucose monitor (CGM) system, the Dexcom G6. The new sensor is smaller than current CGM devices, about the size of a quarter. It comes already calibrated from the factory, thus freeing users from daily finger sticks. It is formatted as...
27
Mar 2018

Bionest

Chasing Migraine

Migraine is the most prevalent neurological disorder worldwide. It causes not only painful headaches, but can also be associated with nausea, vomiting, light and noise sensitivity, and fatigue. A migraine attack can last from a few hours to several days. And while 90% of those who suffer from migraines experience them fewer than 15 days...
12
Mar 2018

Bionest

Alzheimer’s Disease: Continued Clinical Failure and a Potential New Development Pathway

Alzheimer’s disease continues to be a costly and frustrating minefield for drug developers. Most recently, Boehringer Ingelheim halted development of the phosphodiesterase type 9 (PDE9) inhibitor BI 409306 after it failed in phase 2. Merck also ended its trial of verubecestat, the company’s beta-secretase-1 (BACE1) inhibitor, in early stage Alzheimer’s disease patients for futility, a few...
5
Feb 2018

Bionest

Lynparza — Extending Cancer Treatment Based on Underlying Genetic Cause

On January 12, the U.S. Food and Drug Administration approved Lynparza (olaparib), the PARP inhibitor partnered by AstraZeneca and Merck, for the treatment of BRCA-mutated, HER2-negative advanced metastatic breast cancer.   The FDA’s action adds another cancer type for Lynparza; in late 2014 it was the first PARP inhibitor to be approved for use in...
13
Nov 2017

Bionest

Kite Gains First Adult CAR-T Approval

Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval, which came more than a month ahead of the expected FDA decision date, is for...
9
Nov 2017

Bionest

Gene Therapy for Inherited Retinal Disease Achieves a Historic Milestone

This has been an amazing year in the world of drug development, with three new therapeutic classes marking historic gains. We first saw Novartis’ FDA approval for the first CAR-T immunotherapy. Then Alnylam’s RNAi treatment achieved Phase 3 success, the first such for that class of therapeutics. Most recently, Spark Therapeutics received a unanimous recommendation...
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...