8
May
2017
Tag: strategy
2
May
2017
Bionest
A Look at Duchenne Muscular Dystrophy: Part 1 – Marathon Pharmaceuticals, PTC Therapeutics, and Drug Pricing
In February of this year, Marathon Pharmaceuticals received approval for Emflaza (deflazacort) tablets and oral suspension for the treatment of patients over the age of five years with Duchenne muscular dystrophy (DMD), regardless of the particular genetic mutation associated with their condition. The drug — an older corticosteroid with no patent protection which has...
25
Apr
2017
Bionest
Win One/ Lose One: Latest Rulings in the IP Battles Over CRISPR/Cas9
On March 28, the latest round in the intellectual property battle over CRISPR/Cas9 ended with the European Patent Office (EPO) ruling in favor of the University of California / University of Vienna, the work of scientists Jennifer Doudna and Emmanuelle Charpentier, and licensee CRISPR Therapeutics. The EPO granted the University of California (UC) a wide-ranging...
17
Apr
2017
Bionest
Reflecting on AACR
The American Association for Cancer Research annual meeting is always a source of major news and discussion on the oncology research front, and the 2017 meeting held earlier this month was no exception. One area of particular interest was the encouraging data on long-term survival that is emerging for some patients treated with immuno-oncology...
5
Apr
2017
Bionest
PARP Inhibitors Chalk Up Impressive Gains in Ovarian Cancer Maintenance Therapy
On March 27, the FDA gave Tesaro a broad approval for its PARP inhibitor, niraparib, as maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after a complete or partial response to platinum-based chemotherapy. The FDA decision came well in advance of the PDUFA date set for June 30, and...
30
Mar
2017
Bionest
Alzheimer’s Disease Part Three: Meeting 2025 Goals
In early 2011, the National Alzheimer’s Project was formed — a strategic plan aimed at addressing the looming health care crisis posed by the disease and the aging population. Its aim: to coordinate research efforts across the U.S. federal government with the goal of preventing or effectively treating Alzheimer’s Disease by 2025. Since then,...
21
Mar
2017
Bionest
Alzheimer’s Disease Part Two: Effecting Change – The Need for Validated Biomarkers of Risk and Response
We recently wrote about the continued, costly failure of Alzheimer’s disease drugs, often occurring in Phase 3 clinical development. Of 244 compounds tested from 2002 to 2012, only one gained approval. Today there are four compounds on the market for Alzheimer’s disease (of six total approved since research began), all aimed at treating symptoms rather...
16
Jan
2017
Bionest
FDA Grants Priority Review for KEYTRUDA® IN MSI-H Cancers
On November 28, the U.S. Food and Drug Administration granted Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in the new indication of microsatellite instability-high (MSI-H) cancer. MSI-H is a biomarker caused by a deficiency in a cell’s ability to repair errors in DNA sequences that occur during cell division. The...
28
Nov
2016
Bionest
No Matter What You Think of the U.S. Election Outcome…
By Alain J. Gilbert, Co-Chair, Bionest Partners The U.S. Presidential election is over. No matter how you personally feel about the outcome, the fact of Donald Trump’s election is likely to be positive for the healthcare industry and biopharma. The reason: the issue of new drug pricing is not going to be a top...
5
Oct
2016