Phase I
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
One of the eagerly anticipated presentations at the AAIC being held this week is Biogen and its partner Eisai on their controversial drug ADUHELM™ (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
The companies will co-finance a clinical study to test the combination of SHP2 inhibitor BBP-398 and OPDIVO in treating patients with advanced solid tumors KRAS mutations.
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).
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.
The study will also investigate the oral combination with PD-1 inhibitor pembrolizumab in EBV+ metastatic nasopharyngeal carcinoma (RM-NPC).
Genentech announced that the FDA has green-lit the Venclexta classification and azicitidine combination as a Breakthrough Therapy Drug.
It was a moderately busy mid-summer week for clinical trial news. Here’s a look.
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