28
Jan
2019
Tag: FDA
2
Jan
2019
Bionest
Happy New Year — Some Thoughts on the Year to Come
Welcome to 2019. We hope you enjoyed the holidays and look forward to meeting and greeting many of you next week in San Francisco for Biotech Week. Several members of the Bionest team will be in attendance, and if you’d like to get together, we look forward to hearing from you. Last year, we...
14
Nov
2018
Bionest
A Crowded Field for Migraine Therapies, Where Recently There Were None
Back in March, when we first wrote about migraine drug development, there were no approved therapies addressing the underlying mechanisms of these painful, sometimes chronic, headaches — the most prevalent neurological disorder worldwide. Now, three such drugs have reached the market. The three drugs — Aimovig (erenumab) from Amgen/Novartis, Ajovy (fremanezumab) from Teva Pharmaceuticals,...
5
Nov
2018
Bionest
DEA Greenlights Epidiolex Launch with Drug Schedule Reclassification
Earlier this year, we wrote that GW Pharmaceuticals was poised to receive the first approval from the U.S. Food and Drug Administration (FDA) for a drug derived from the cannabis plant — Epidiolex (cannabidiol, also known as CBD), a treatment for seizures related to Lennox-Gastaut syndrome and Dravet syndrome, rare forms of epilepsy. The FDA...
29
Oct
2018
Bionest
First RNAi Drug Hits the Market — At a Very High Price
On August 13, the U.S. Food and Drug Administration (FDA) approved Alnylam’s Onpattro (patisiran), rapidly followed by that product’s approval in Europe three weeks later. Onpattro, which we previously wrote about, is the first RNAi-based treatment to reach the marketplace. It is intended to treat peripheral nerve disease caused by a rare genetic condition called...
17
Sep
2018
Bionest
FDA Issues Set of Guidelines on Gene Therapy
Back in December, the U.S. Food and Drug Administration (FDA) granted its first approval for a gene therapy product, Spark Therapeutics’ Luxturna. According to the Alliance for Regenerative Medicine, as many as 50 more such treatments — addressing a diverse range of health problems from genetic, autoimmune, and heart diseases, to cancer and HIV/AIDS —...
13
Aug
2018
Bionest
Positive Results Reported in Alzheimer’s Disease — But Questions Remain
In early July, Biogen and Eisai announced that analysis of their 18-month Phase 2 trial of BAN2401 revealed encouraging results, showing an effect on both lowering of amyloid levels and slowing of cognitive decline in patients treated with the highest dose of the drug. This spurred some analysts to hail the news as encouraging support...
16
Jul
2018
Bionest
A New ‘Neulasta’: First Biosimilar Version Gains FDA Approval
In early June, the U.S. Food and Drug Administration (FDA) approved the first biosimilar version of Amgen’s Neulasta (pegfilgrastim), a biologic that is used to reduce the chances of infection in cancer patients whose immune system have been suppressed by chemotherapy. The new biosimilar, developed by Mylan and Biocon, is expected to launch as Fulphila...
25
Jun
2018
Bionest
First Up For The New FDA RMAT Designation: Gene Therapeutics for Hemophilia
We recently wrote about the U.S. Food and Drug Administration’s (FDA) creation of a Regenerative Medicine Advanced Therapy (RMAT) designation in an effort to speed up the approval process for certain types of treatments, including gene therapies. The agency has specifically chosen gene therapy for hemophilia as its first focus, due to the considerable effort...
11
Jun
2018