2
May
2017
Tag: Biotech
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...
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...
3
Apr
2017
Bionest
National Academies of Science and Medicine Cautiously Endorse Some Germline Gene Editing — In the Future
In February the National Academy of Sciences and the National Academy of Medicine issued a new report on the technical, social and regulatory concerns surrounding gene editing, entitled, “Human Genome Editing: Science, Ethics, and Governance.” Authored by a 22 member panel of scientists, ethicists, lawyers, physicians and geneticists from around the world, the report...
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...
21
Dec
2016
Bionest
21st Century Cures Act Heads for Signing, with Aim of Boosting Research and Easing Drug Approvals
On December 13, President Barack Obama signed the 21st Century Cures Act. The landmark bi-partisan health and science bill, which passed the U.S. Senate by a vote of 94 to 5, provides $6.3 billion in funding over 10 years, including $4.8 billion to the National Institutes of Health in support of such programs as...
8
Dec
2016
Bionest
Moonshot: On its Way
On September 17, Vice President Joe Biden released his final report on the Cancer Moonshot before leaving office. He announced progress on over 20 programs now underway during the effort’s first year or soon to be launched, and another two dozen for the second year of the effort and beyond. Back in September we...
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...
14
Nov
2016