14
Jun
2017
Tag: business development
6
Jun
2017
Bionest
Roche Gains Important MS Approval — and Takes Unprecedented Pricing Steps
On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS). The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for the treatment of PPMS, a form of the disease that accounts for 10-15% of MS...
26
May
2017
Bionest
It’s ASCO Time Once Again!
ASCO is the largest annual gathering of the worldwide oncology community, and this year’s event takes place this coming weekend, from June 2-6 in Chicago, Illinois. About 10 days ago, the association released its program and a wide slate of abstracts that have given way to plenty of media reports and speculation about what other...
16
May
2017
Bionest
A Look at Duchenne Muscular Dystrophy: Part 3 – The Increasing Activism and Influence of Patient Advocacy Groups
On September 19, 2016 the US Food and Drug Administration approved Sarepta’s Exondys 51 (eteplirsen) injection, the first drug approved to treat the underlying cause of Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13...
8
May
2017
Bionest
A Look at Duchenne Muscular Dystrophy: Part 2 – About DMD, and Approaches to Treatment, Old and New
Duchenne Muscular Dystrophy (DMD) is a rare genetic disease characterized by progressive muscle degeneration and weakness. It is one of the most frequent genetic disorders, affecting approximately 1 of 3,600 (primarily) male children. The disease is caused by a mutation in the gene for dystrophin on the X chromosome that results in the absence of...
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...
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...
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...
5
Oct
2016