Topic:

R&D

Latest Headlines

Latest Headlines

Lipocine's low-T drug hits the mark in Phase III. Now it has to sway the FDA

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.

Purdue team recreates tumor microenvironment to study cancer nanomed delivery

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.

UPDATED: Titan Pharma trial of implant for addicts on track

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.

Biogen shoulders into gene therapy amid a second honeymoon for the field

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.

Dartmouth mobile app detects depression and stress levels

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 keeps prenatal Dx competition running with new positive data

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 bags $3M to expand its eClinical suite

BBK Worldwide has raised $3 million to finance an expansion of its suite of eClinical software.

TransCelerate dishes on risk-based monitoring

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.

TransCelerate shares its take on risk-based monitoring models and tech

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.

Cubist makes Euro landfall with a $400M purse for antibiotics R&D

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.