Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Amgen notches positive PhIII results for top cancer drug

Once again, Amgen's R&D chief Sean Harper has Roger Perlmutter to thank for a positive late-stage outcome on one of the Big Biotech's top cancer prospects.

Latin American cancer vax races Big Pharma rivals

The lung cancer vaccine race has brought together an unusual mix of players. Merck KGaA was in a good position, but its vaccine disappointed in Phase III, while GlaxoSmithKline could report data on its candidate this year. Then there is the Cuba-Argentina joint venture.

GlaxoSmithKline's research chief in China fired for data fraud

The head of GlaxoSmithKline's R&D operation in China has been fired while another researcher has resigned following a company probe into allegations that data on interleukin-7 research published in Nature Medicine was "misrepresented" by company researchers.

FDA lifts clinical hold on anthrax vaccine

The FDA has lifted the clinical hold on PharmAthene's anthrax vaccine candidate, SparVax.

FDA clamps clinical hold on Pluristem PhII stem cell trial

One of the patients enrolled in a mid-stage study for an experimental stem cell therapy from Pluristem Therapeutics suffered a severe allergic reaction, sending him to the hospital and prompting FDA officials to clamp a clinical hold on the study.

Sanofi takes $285M charge after racking up back-to-back PhIII trial failures

Sanofi's iniparib failed a Phase III study for squamous non-small cell lung cancer, the final strike against a once-promising drug that has proved a bitter disappointment for the pharma giant.

Chinese HFMD vaccine impresses in Phase III

Things happen quickly when China coordinates the cogs of its state infrastructure. One year ago a state-funded vaccine for one cause of hand, foot and mouth disease reported Phase I data. Phase II results followed in January, and now Phase III data has arrived.

Novo spearheads $175M financing to back Ophthotech's PhIII AMD study

New York-based Ophthotech has rounded up a whopping $175 million in financing to cover a pivotal late-stage study of its lead drug for wet AMD. The biotech signed a deal to share its royalties on Fovista--earlier dubbed E10030--with Novo A/S in exchange for $125 million. And Novo stepped up to lead a $50 million Series C round for the company.

Researchers seek fresh approach to HIV vaccine

Last month's cancellation of the largest ongoing HIV vaccine trial stopped yet another promising candidate. The growing pool of clinical failures shows that a new approach is needed. This past week, academia offered up two new angles of attack.

University of Alabama begins Parkinson's biomarker study

Researchers at the University of Alabama are investigating whether a reduced sense of smell, or hyposmia, could be used as a biomarker to help detect Parkinson's disease.