Drug Development
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
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The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
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At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
AstraZeneca will give up on seeking approval for its COVID-19 vaccine in the United States. It is also abandoning three early-stage programs.
An anti-CD70 antibody drug conjugate developed by Ambrx, Inc. has been administered to the first patient in a Phase I study in China. It marks the first ADC in active development that targets CD70.
Oncolytics Biotech released data Thursday from a Phase I/II study in pancreatic ductal adenocarcinoma that support plans to advance the program into Phase III.
With a fresh $18 million in the bank, NRG Therapeutics is ready to put its novel mitochondrial approach to the test for devastating neurodegenerative disorders—Parkinson’s and ALS.
Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
The FDA deemed AstraZeneca’s PT027 to have a favorable risk-benefit profile for treating asthma in patients aged 18 or older but was less keen on supporting the drug in younger populations.