A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.
Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.
If you take some time with Bionomics' release on the Phase II study of their lead cancer drug you'll see that the trial failed, with progression-free survival for a combo use of the therapy with Afinitor tracking closely to the same PFS rate for renal cancer as a control arm which was treated with Afinitor only. The investment community apparently managed to accomplish the heavy lifting, though, pushing shares for the Australian penny stock company down 30% after the data drop.
After the markets closed last night, Prosensa issued an upbeat self-assessment of its 48-week extension data from a Phase II study of its lead drug drisapersen for Duchenne muscular dystrophy.
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.