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.
It was Johnson & Johnson's turn to take center stage at ASCO Saturday morning, fleshing out the promising data that it accumulated in a Phase II study of daratumumab for treatment-resistant multiple myeloma.
Heron Therapeutics is gearing up for a third attempt at FDA approval for its chemotherapy-induced nausea and vomiting drug, posting a Phase III success after repeated delays.