Lynparza — Extending Cancer Treatment Based on Underlying Genetic Cause

On January 12, the U.S. Food and Drug Administration approved Lynparza (olaparib), the PARP inhibitor partnered by AstraZeneca and Merck, for the treatment of BRCA-mutated, HER2-negative advanced metastatic breast cancer.   The FDA’s action adds another cancer type for Lynparza;… Read »

Alzheimer’s Disease: The Case for Drug-Diagnostic Partnerships

Developing an Alzheimer’s disease drug has been notoriously expensive and high risk. Part of the problem has been the difficulty in identifying the right patients for clinical trials and at the right time – that is, those patients showing early… Read »

Celebrating Clinical Success in Depression

Depression is a difficult problem for drug developers. Current marketed antidepressants are effective for a relatively small percentage of patients (about 20 in 100) and most require weeks of treatment to show an effect. Patients often need to try several… Read »

Welcome to 2018! What we are watching for JPM18 and the coming year…

Now that the holidays have wound down, we look forward to catching up with many of you in person as the Bionest team and many others from across the healthcare business world descend on San Francisco next week for the… Read »

A First Glimmer of Hope for Huntington’s Disease Patients

Huntington’s disease is a devastating and progressive inherited disorder that is caused by the expansion of the CAG trinucleotide sequence in the huntingtin (HTT) gene. This mutation results in abnormally long versions of the HTT protein, which progressively destroy neurons… Read »

It’s a pill. It’s a device. It’s both. FDA Approves the first Digital Drug Therapy

Adherence to prescription drug therapies is a big problem, not only for patients and drug developers, but also for payers who cover the costs of such medications and then pay to treat problems the drugs were meant to prevent. About… Read »

A New Precision Medicine Initiative in Parkinson’s Disease… and Perhaps Other Neurologic Conditions

Cancer was once considered a single disease, but today we are well aware of the many different forms this medical scourge can take, and the many molecular events that can lead to and drive unwanted cell growth. Now, a new… Read »

Giving Thanks in IO

The immuno-oncology (IO) field has a lot to be thankful for as the year comes to a close.   Not only are PD-1/PDL-1 inhibitors being rapidly approved, their use is being extended into new indications and tumor types well beyond… Read »

Kite Gains First Adult CAR-T Approval

Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval,… Read »

Gene Therapy for Inherited Retinal Disease Achieves a Historic Milestone

This has been an amazing year in the world of drug development, with three new therapeutic classes marking historic gains. We first saw Novartis’ FDA approval for the first CAR-T immunotherapy. Then Alnylam’s RNAi treatment achieved Phase 3 success, the… Read »

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