News and Analysis in 2012

With multiple drug candidates in the clinic that originated from fragment-based lead discovery, the approach of starting small has become big.

Last year saw the largest loss of revenue yet from major drugs due to patent expiries, but a continuation of 2011's higher level of drug approvals and new initiatives to address R&D challenges provide hope for the future.

After more than a decade of clinical development for cancer and numerous failures, Phase III trials of cyclin-dependent kinase inhibitors are beginning.

Moves to release more data from clinical trials could provide unprecedented opportunities to understand disease biology and drug effects.

Long-standing efforts to develop drugs that target MEKs could soon come to fruition, moving the frontier to how best to combine them with other cancer therapies.

Less than a decade on from genetic studies indicating the potential of PCSK9 as a target to affect cholesterol metabolism, two PCSK9 inhibitors are moving into late-stage development.

Economists hope they can attract billions of dollars for drug R&D by securitizing research projects. Could they close the innovation gap in the process?

After decades of stubbornly slow progress in asthma drug development, recent results from a trial of GlaxoSmithKline's mepolizumab hint at a brighter future.

A proposal to replace widely criticized trial regulations could boost European drug development, if key details can be sorted out.

Three prevention trials in asymptomatic Alzheimer's disease patients will attempt to validate the amyloid hypothesis, evaluate biomarkers and set the stage for drug approvals.

A new €32 million project aimed at understanding drug-induced liver injury is the latest of several collaborative efforts that could help drug firms better test for candidate-killing toxicity signals.

20 years after the first PDUFA provided the FDA with additional resources, regulators and industry are refocusing on review times and approval rates.

What will schemes designed to get industry's discarded drug candidates into the hands of academic researchers deliver?

Toll-like receptor agonists have hit another setback with the Phase II failure of Idera's IMO-2055, but these immunotherapies may still make a comeback if appropriate combinations with vaccine antigens or anticancer drugs can be identified.

With the first biosimilar version of a monoclonal antibody now under regulatory review in the European Union, which R&D strategies are innovators relying on to counteract competition?

The gout space is heating up, but is there sufficient room in the market to accommodate multiple new therapeutics?

Researchers are starting to use high-throughput genomic technologies to guide patients into trials of experimental cancer therapies, but is our understanding of the cancer genome ready yet?

Following an FDA advisory committee vote to restart clinical development of nerve growth factor antagonists, could this novel class of analgesics still fulfil its once-anticipated potential?

Approval for Genentech's vismodegib marked the first approval for a Hedgehog inhibitor, but questions remain for the class's broader role in other cancers.

First data from the FDA's new active surveillance programme highlight how the system might influence drug development programmes.