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 »

Running the Risks of High Stakes Drug Development

On August 5, Bristol-Myers Squibb (BMS) surprised many with the announcement that their PD-L1 inhibitor Opdivo® (nivolumab) had failed a Phase 3 trial assessing its use as a monotherapy in the first-line treatment of non-small cell lung cancer (NSCLC). This is a… Read »

Update on the “Cancer Moonshot”

In March, we wrote about the “Cancer Moonshot” Initiative that was announced as part of President Obama’s 2016 State of the Union Address. Headed by Vice President Joe Biden, the aim of the initiative was to facilitate collaboration in cancer… Read »

Not Quite What the Headlines Suggest: Some Comments on Drug Pricing Issues

We recently had the opportunity to participate in an industry roundtable discussion on pharmaceutical pricing, organized by the editors of Life Science Leader. The discussion included perspectives from members of the pharmaceutical and biotech industry, patient advocates (from FasterCures and… Read »

Collective Wisdom Around Oncology – Comments on ASCO 2016

The Bionest Oncology team spent a jam packed and exciting five days at ASCO 2016 earlier this month in Chicago.  More than 30,000 oncology professionals gathered from all around the world to discuss the latest data and innovations in oncology,… Read »

The National Microbiome Initiative

On May 13, the White House announced the latest big science initiative: a pledge of a half billion dollars to study microbes in humans, crops, soils, oceans and more. This initiative  — which includes $121 million in Federal funding over… Read »

Some Thoughts on the Latest Immuno-oncology Approval

On May 18, the U.S. Food and Drug Administration approved the latest immunotherapeutic drug, atezolizumab (Tecentriq), from Roche’s California division, Genentech. The drug, a PD-L1 inhibitor, is the first product in its class to gain approval for a common form… Read »

See you at ASCO 2016!

It’s nearly June, which means one thing for the Bionest Oncology team:  ASCO is right around the corner.  As we gear up for our time in Chicago, we are taking a look at some of the big topics and anticipated… Read »

“Beyond the Pill” – Part Three: Patient-centricity Creates New Business Opportunities Outside Pharma, Too

Factors are converging that make patient-centric initiatives a key business opportunity, not just for pharmaceutical and biotechnology companies with treatments to develop and market, but increasingly also for those outside of the traditional health care industry.   One of the… Read »

“Beyond the Pill” — Part Two: Value-Added Services Offer Benefit to Multiple Audiences

In our first “Beyond the Pill” post, we discussed the increasing move towards patient-centric programs that go past an actual prescription to help build relationships with patients and physicians and facilitate the provision of a number of related services to… Read »

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