BioSpace News Archive

Novartis announced that its BYL719 (alpelisib) met the primary endpoint of progression-free survival (PFS) in its Phase III SOLAR-1 trial. The drug is an alpha-specific PI3K inhibitor, a category of cancer drugs that has a troubling history of adverse events.

Pfizer and Astellas Pharma announced they have amended the protocols for two Phase III clinical trials, ARCHES and EMBARK, to evaluate Xtandi (enzalutamide) in hormone-sensitive prostate cancer (HSPC). Both trials will wrap sooner than planned as a result.

Shares of Innovate Biopharmaceuticals are up more than 7 percent in premarket trading after the company announced it signed an agreement with privately-held Amarex Clinical Research to provide data management and biostatistics for its planned Phase III celiac disease trial.

Researchers at the University of Texas Health Science Center at San Antonio have found a type of cellular stress in Alzheimer’s disease for the first time that is involved in cancer and aging. The stress is called cellular senescence, which is linked to the tau protein tangles associated with end-stage Alzheimer’s disease. The research was published in the journal Aging Cell.

The NIH’s National Institutes on Aging (NIA) and the Alzheimer’s Association brought together various experts and stakeholders to create the National Strategy for Recruitment and Participation in Alzheimer’s Disease Clinical Research.

AstraZeneca has seen another setback in a late-stage trial for chronic obstructive pulmonary disease (COPD) treatments. The latest stumbling block includes a failure for AstraZeneca’s investigational treatment to distinguish itself from a drug already marketed by rival GlaxoSmithKline.

The U.S. Food and Drug Administration has posted new draft guidance that will guide drug and medical device manufacturers that aim to develop treatments for “the underlying pathophysiology and structural progression” of osteoarthritis (OA).

Cambridge, Mass.-based bluebird bio and Gritstone Oncology inked a deal to combine gene and cell therapies to target cancer. This morning California-based Gritstone said it will leverage its artificial intelligence platform, dubbed EDGE, to analyze specific tumor types for the collaboration.

There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.

As Brexit creeps closer and closer, the British government, as well as pharmaceutical companies and the European Medicines Agency, are preparing contingency plans for dealing with the possibility that healthcare-related companies will not have contracts in place in time.