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… Read »

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… Read »

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… Read »

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… Read »

Alzheimer’s Disease: Part One – Another One Bites the Dust

Alzheimer’s Disease: Part One – Another one bites the dust, but a possible glimmer of hope on the horizon   On February 14, Merck halted the Phase 3 trial of its Alzheimer’s disease drug candidate, verubecestat, after independent analysis showed that… Read »

Chan Zuckerberg Initiative Makes First Bio Research Awards

Last fall, the Chan Zuckerberg Initiative announced plans to invest $3 billion over 10 years in scientific efforts with an ambitious long-range aim to “cure, prevent or manage” all diseases. As a first part of that effort, they directed $600… Read »

Communicating Value

— Robert J. Easton, Co-Chairman, Bionest Partners   During the annual January gathering of the biopharma world in San Francisco this year, in-coming President Donald J. Trump put drug developers on notice and sent pharmaceutical and biotechnology stock prices plunging… Read »

The Orphan Drug Act: Successes and Challenges

By Alain J. Gilbert, Co-Chair, Bionest Partners   Rare and orphan diseases have grown dramatically as a focus of drug development since the passage of the Orphan Drug Act and the institution of other regulatory and financial incentives in both… Read »

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… Read »

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,… Read »

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