On Friday night Intercept Pharmaceuticals managed to rattle investors with a 10-K filing flagging a collection of serious cardiac adverse events recorded in a study of its lead drug OCA. But come Sunday morning, the biotech balanced out that bitter taste with an announcement that its Phase III trial had ended with positive data, setting up a regulatory filing for approval.
Chimerix will evidently have no trouble finding the 20 patients it is recruiting for the pilot study of its antiviral brincidofovir. And it still isn't willing to provide its therapy under the FDA's "compassionate use" regulations.
A new round of late-stage data on Amgen's cancer-fighting viral vaccine talimogene laherparepvec, better known as T-Vec, found that about two-thirds of the tumors injected with T-Vec shrank 50% or more. And the same effect was seen in about a third of all uninjected tumors in the skin and lymph nodes, providing an indication that the treatment is triggering the desired immune system effect.
Last month Pfizer presented positive headline results from its massive Prevnar 13 trial, but the release was light on the details that could shape whether the data leads to an expanded recommendation. Now Pfizer has published a closer look at the data, and not everyone likes what they see.
Over the past 20 years researchers have learned celiac disease is more common than previously thought and is linked strongly to genetic factors. This new knowledge led to the development of two theories--a vaccine for celiac disease can be created, and it could become a big seller.
GlaxoSmithKline says it nailed the primary endpoint in a Phase III study of its injectable IL-5 drug mepolizumab, beating out a placebo with statistically significant results for severe eosinophilic asthma and setting the stage for the first regulatory filings for the drug.
As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.
Geron is back in the tank. The biotech's shares were in meltdown mode Wednesday morning, plunging about 60% in premarket trading after the company announced that the FDA put its one and only drug imetelstat on a full clinical hold after detecting a risk of long-term liver damage following prolonged exposure to the treatment.
On Tuesday morning, Chimerix CEO Ken Moch was at the center of a media storm, maintaining that there was no way the biotech could responsibly provide its experimental antiviral to a dying child named Josh Hardy, a drug the boy's parents vowed was all that could save the child's life. By Tuesday night, though, Moch had found a way to give the treatment to the 7-year-old after all, as part of the clinical development program for the drug.
La Jolla Pharmaceutical's chronic kidney disease drug hit its primary endpoint of improving organ function in a Phase II trial, the company said, and while the results sent the biotech's shares skyward by 75%, a quirk in dosing gave some analysts pause.