AstraZeneca says that its experimental gout drug lesinurad failed to hit the primary biomarker target for the dose that it's now seeking regulatory approval for in the U.S. and Europe. And this latest Phase III--the last of a trio--continues to demonstrate that the pharma giant can't land evidence that the drug provides a clear benefit to patients in the time allotted for the study.
Agios Pharmaceuticals' lead cancer drug extended its streak of promising clinical results, racking up remissions in an expanded Phase I trial as the company prepares for late-stage testing.
Genmab has moved a step closer to seeing daratumumab approved in double refractory multiple myeloma. A rolling submission for the breakthrough cancer therapy is now underway, raising hopes that the product will be on the market early next year.
Another indication may be on the horizon for the generic BCG vaccine as Massachusetts General Hospital got an OK from the FDA for a Phase II trial of the vaccine's ability to help patients with Type I diabetes.
Developing new drugs for depression has become one of the most frustrating tasks in biotech as companies have struggled to demonstrate a positive effect against hard-to-control placebo responses in clinical trials or prove that dramatic and quick responses in small groups can translate into safe and broadly used drugs. Sage Therapeutics, though, is touting the results it's seen in just four patients.
Each year, health authorities make predictions about which flu strains will be the most common. But if the strains mutate, flu vaccines are powerless to prevent infection. Enter VaxInnate, which is taking its quick-to-produce quadrivalent seasonal flu vaccine into Phase II safety trials.
MorphoSys has released an early look at data from a Phase I/IIa trial of multiple myeloma drug MOR202. While the results are free from major red flags, the publication of Phase II data on Genmab and Johnson & Johnson's rival anti-CD38 drug just days earlier showed the scale of the task now facing MorphoSys.
A Phase III trial of NeuroVive Pharmaceutical's CicloMulsion in heart attack patients has missed its primary endpoint. And while NeuroVive is still hoping to find positives in a full analysis of the 12-month data, the setback nonetheless wiped more than 50% off the company's share price.
Just 6 weeks after seeing disappointing data from its Phase III study of tasquinimod for prostate cancer, Sweden's Active Biotech is laying off 47 staffers, leaving only 9 employees at the company.
CTI BioPharma and its partner Baxter outlined positive Phase III data for their myelofibrosis drug pacritinib, which may help pave a way to position the therapy against Jakafi next year.