Bionest

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 what people expected. From melanoma and lung cancer to bladder, gastric and liver cancer, drugs...

Bionest

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, which came more than a month ahead of the expected FDA decision date, is for...

Bionest

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 first such for that class of therapeutics. Most recently, Spark Therapeutics received a unanimous recommendation...

Bionest

Search for an Alzheimer’s Treatment Goes On

Anticipation was high for the results of a Phase 3 trial of Axovant’s experimental drug, interpirdine. Sadly, the potential Alzheimer’s disease treatment failed to meet its co-primary endpoints. Patients with mild to moderate Alzheimer’s disease who were treated for 24 weeks with 35 mg interpirdine, along with the existing Alzheimer’s disease drug Aricept, failed to...

Bionest

RNA Interference Achieves Key Milestone with Patisiran Success

It is a not uncommon phenomenon for a new discovery to attract much enthusiasm and hype — as well as investment and new company formation — only to suffer popular disillusionment a few years later as public interest turns to the next hot area of science when clinical success remains elusive and far off. After...