News and Analysis in 2015

Approvals of Janssen's daratumumab and Bristol-Myers Squibb's elotuzumab cap a stellar year for multiple myeloma therapies, providing two new mechanisms of action and prompting a slew of combination trials.

Just weeks after an FDA advisory meeting on the use of vaccines in pregnant women to protect newborn babies, Novavax has launched the first ever Phase III trial of a vaccine for maternal immunization licensure.

Industry and academic scientists are working together to figure out when and how best to use phenotypic screening in drug discovery.

Clinical success with Trevena's 'biased' G protein-coupled receptor ligand highlights the potential of exploring the nuances of receptor pharmacology.

First pivotal study win for Merck & Co.'s antibacterial antibody suggests that biologics could at last bring precision medicine to the anti-infective space.

Digital prescription pills, set to hit the market soon, offer the opportunity to address key drug adherence challenges in clinical practice and clinical trials.

AstraZeneca and Clovis Oncology have submitted their next-generation EGFR kinase inhibitors for regulatory review.

Novartis' newly approved heart failure therapy Entresto could set precedents by bringing outcome-based pricing for a primary care drug to the United States.

Amyloid-targeted antibodies seem to have a small clinical benefit in patients with mild Alzheimer disease, but issues with the design and interpretation of the trials curb enthusiasm.

Induced pluripotent stem cell-derived 'disease-in-a-dish' models have propelled neurological drugs from Bristol-Myers Squibb, GlaxoSmithKline and Roche into clinical trials.

After decades of delays, biotechs hope that bacteria-attacking viruses could provide an alternative to traditional antibiotics.

An umbrella trial of 25 targeted treatments in all cancer types tackles treatment selection on the basis of genetic events rather than by tumour histology.

Intercept Pharmaceuticals has announced plans for the first ever pivotal trial in non-alcoholic steatohepatitis (NASH), setting a high bar for a growing pipeline of drugs against the liver disease.

Novel inhibitors of bacterial β-lactamases should restore activity to old antibiotics and hold back the tide of drug-resistant infections.

Industry experts ask for regulatory guidelines and assurance on the value of well-designed Phase IIb dose-finding studies to help overcome long-standing resistance to sophisticated dose-finding strategies.

The future of cancer-killing viruses lies in their potential to augment cell and antibody immunotherapies.

What impact will advances in automated chemical synthesis have for medicinal chemists?

Pfizer, Eli Lilly, Janssen and Regeneron are advancing a promising class of analgesic drugs, hoping to put concerns around autonomic dysfunction and joint destruction behind them.

A beleaguered class of epigenetic modulators continues to struggle for oncology success, but new insights into their mechanisms in cancer may yet offer hope.

The US National Institutes of Health's US$240-million epigenomics investment could improve the study of disease biology, the identification of new targets, the validation of animal models and more.