Lipocine is touting positive late-stage results for its testosterone replacement pill, gearing up for intense FDA scrutiny amid a sea change in how the regulator looks at so-called low-T treatments.
A Purdue University team has created a new chip that promises to help test how cancer-killing nanoparticles react in a tumor environment. Because different nanoparticles perform vastly different functions in drug delivery, it's important to determine early on what kind of effect they will have on a tumor and what it would take to improve their outcome.
Titan Pharmaceuticals said yesterday that the Phase III study of its Probuphine subdermal implant for the treatment of opioid dependence is now halfway to full enrollment and on track to conclude by mid-2015, giving the company a second crack at FDA approval.
As researchers and investors toast renewed optimism for a new generation of gene therapies, biotech bellwether Biogen Idec is deepening its commitment to the space, another sign of life for the resurgent field.
Lonely, depressed, stressed? There's a smartphone app that can read your mood like a book. At Dartmouth, student researchers developed and tested StudentLife, an app that can detect depression and stress levels.
Sequenom, facing a crowd of rivals in the prenatal diagnostics space, is heralding a massive amount of new postmarketing data as proof of accuracy and sensitivity for its signature test.
BBK Worldwide has raised $3 million to finance an expansion of its suite of eClinical software.
TransCelerate BioPharma, a nonprofit founded by the world's biggest drugmakers to make R&D more efficient, is encouraging developers to adopt risk-based monitoring for clinical trials, disclosing its thinking in two research papers.
With clinical trial sponsors spending a sizable chunk of their huge Phase III trial budgets on source data verification in return for questionable benefits, risk-based monitoring is an obvious target for TransCelerate BioPharma's R&D efficiency agenda. The Big Pharma consortium has further clarified its thinking on the topic in two research papers.
The antibiotics-focused Cubist Pharmaceuticals has opened up shop in Europe with a Swiss international headquarters, part of its plan to spend $400 million on infectious disease R&D this year and spotlight new treatments for global scourges.