6
Dec
2018
Tag: Big Pharma / Specialty Pharma
3
Dec
2018
Bionest
Report on ESMO 2018 – Part One
We recently returned from the European Society for Medical Oncology (ESMO) meeting where conference news highlighted the increased movement of targeted therapies and immunotherapies into adjuvant and early-stage cancer settings, plus plenty of positive data from a variety of combination therapy trials in breast cancer, including triple-negative breast cancer. (Neo)Adjuvant Treatment Gets a Boost ...
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...
8
Oct
2018
Bionest
Gene Therapy Update Part 1: Big Advances and Big Questions for CRISPR
The gene therapy field has seen several developments in recent months, especially around CRISPR, with both significant achievements and further controversies about the safety of the gene editing approach. CRISPR Cure for Duchenne’s Muscular Dystrophy (DMD) in Dogs Eric Olson’s team of researchers at the University of Texas Southwestern’s Harmon Center for Regenerative...
24
Sep
2018
Bionest
U.S. Drug Spending: Where the Money Goes
Two recently published analyses are providing a more in-depth picture of prescription drug spending in the United States. Such evaluations illustrate the complexities facing policy makers and regulators seeking to help reduce patient and payer drug costs. In addition, they point to somewhat hidden issues regarding the pricing and reimbursement of generic drugs that can...
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 —...
20
Aug
2018
Bionest
Drug Pricing and Pharma
In September 2015, Martin Shkreli, then CEO of Turing Pharmaceuticals, sparked widespread outrage in the United States when the company raised prices on an off-patent treatment for toxoplasmosis, Daraprim, by over 5,000%, just one month after Turing acquired the drug. That action catapulted the medicine’s price from $13.50 to $750 per pill. But journalists found...
13
Aug
2018