Drug investigator David Nutt, a longtime thorn in the side of U.K. officials, is back at his favorite pastime. Nutt was kicked out of his post as an official adviser to the government on therapeutics after adopting a controversial stance in favor of testing illicit drugs like magic mushrooms for depression. And now he says "insane" government rules have blocked manufacturers from signing on to supply psilocybin for an approved clinical study.
India is proceeding with its plan to reform how sponsors and CROs pay compensation to patients, but the draft guidance contains some confusing wording that has troubled the industry.
Already sky-high expectations for the experimental cancer drug ibrutinib from J&J and Pharmacyclics managed to arc even higher this morning after the collaborators spread word that the program had just won its third "breakthrough drug" title from the FDA.
CROs competing for big-name deals may face a more crowded market now that on-the-ropes diagnostics companies are getting into the clinical research game, something LabCorp demonstrated this week as it inked a preferred-provider contract with Bristol-Myers Squibb.
Shares of Biogen Idec ($BIIB) surged to around the $197 mark this morning as the company detailed data on its promising Phase IIb study of the multiple sclerosis drug daclizumab.
Merrimack Pharmaceuticals has nailed down the top-line results for one group of cancer patients in a mid-stage trial of Tarceva combined with its lead drug MM-121, partnered with Sanofi. And it's not good.
A paper in JAMA has revealed details of the Merck Staphylococcus aureus vaccine trial that was stopped early in 2011 amid safety concerns. The vaccine was no more effective than a placebo, and was associated with a rise in multiorgan failure.
he vaccine works by immunizing women in their childbearing years, causing them to pass on protective antibodies to guard infants. Now it's on to a pivotal trial.
For most biotechs, the sit-down with the FDA after a positive Phase II study is a fairly routine affair designed to point them down the path to a pivotal program. For Sarepta Therapeutics, though, it represents a strategic crossroad rarely seen in this industry. In one direction lies a lengthy Phase III trial, while the other path points straight to a major new market for Duchenne muscular dystrophy, a terrible affliction faced by a small group of boys.
Clavis Pharmaceuticals shares flat-lined at about 18 cents this morning as the Norwegian biotech company outlined a simple endgame after its second Phase III cancer drug program ended in failure yesterday.