Astellas Pharma Inc. and Pfizer Inc. announced today the amendment of the protocol for the registrational PROSPER trial. The multi-national, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of XTANDI (enzalutamide) in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer.

New cancer drugs that target genetic mutations regardless of where the tumor is growing should expand the practice of testing patients for such glitches, oncology experts say.

Lexicon Pharmaceuticals Inc. today announced positive top-line results from its Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy.

Manufacturers and their communications agencies see great opportunities in a new draft guidance from FDA, but the fear of warning letters still shadows the industry.

Market pressures have continued to threaten pharmaceutical brand revenue while increasing costs. The convergence of these two forces has challenged pharmaceutical manufacturers to improve margin with new and ever-evolving strategies. Only a combination of sophisticated managed markets expertise and real-world analysis can empower brands to maximize profitability in today’s challenging climate.

R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.

This chart shows the 2016 and 2015 revenue and R&D figures for some of the world’s leading biotech and biopharma companies.

Television as a marketing medium seems so, well, 1950s these days. Given the ubiquity of digital and mobile devices and the tracking and targeting opportunities they present, not to mention the lesser cost attached, blasting TV spots out to whomever might be watching could strike the uninformed as old-fashioned. But pharma’s top brand managers clearly don’t think so.

Med Ad News asked industry experts what they thought DTC communications might look like in five years. This is what they told us.

A listing of the top prescription brands by 2016 DTC spend according to Nielsen data.