Clinical research
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
The FDA called for Iterum to conduct an additional clinical study that uses a different drug for comparison and to determine optimal dosing.
The FDA’s ODAC met to discuss retifanlimab and voted 13-4 that a regulatory decision for the drug for this indication should be deferred until more data was available.
Abeona Therapeutics’ shares popped 18.32% in pre-market trading after New York and Cleveland-based company announced magnetic resonance imaging (MRI) data from its Phase I/II Transpher A trial in San Filippo Syndrome Type A (MPS IIIA).
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.
It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
Oramed Pharmaceuticals said that its majority-owned firm Oravax Medical would be spearheading the project, first in Israel and later in other international clinical locations.
Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).
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