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 »

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… Read »

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…. Read »

From Disease Treatment to Patient Care: Thoughts from ESMO 2016

The theme of patient centricity and care that we discussed at this year’s ASCO continued this autumn at ESMO 2016.  The tagline of the conference was ‘From disease treatment to patient care,’ which according to the organizers, “intended to capture… Read »

Chan Zuckerberg Initiative Funds $3 Billion Science Effort to Cure or Manage All Diseases by 2100

On September 21, Facebook CEO and billionaire, Mark Zuckerberg, and his pediatrician wife, Dr. Priscilla Chan, announced a new, privately funded big science effort. The couple pledged more than $3 billion toward a plan to “cure, prevent or manage all… Read »

Blue Ribbon Panel Issues Cancer Moonshot Recommendations

On September 7, a Blue Ribbon Panel — composed of 28 top cancer researchers, oncologists, patient advocates and leaders from the private sector — issued 10 recommendations aimed at speeding up advances in cancer prevention, diagnosis, treatment and care. The… Read »

Mapping the Brain: Dawn of a New Era for Neuroscience Research?

On July 20, a team of neuroscience researchers from Washington University in St. Louis, Missouri and other centers published a precise new brain map in Nature — an outcome of the White House BRAIN (Brain Research through Advancing Innovative Neurotechnologies)… Read »

PRIME Launched by EMA to Speed Review and Approval of Innovative, “Breakthrough” Drugs

Four years ago, the US Food and Drug Administration launched its “breakthrough designation” program, designed to speed the review and potential approval of new therapeutics deemed to offer the possibility of substantial improvement over existing options for patients with life-threatening or… Read »

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