The FDA has granted accelerated approval to Merck's Keytruda, or pembrolizumab, as a treatment for patients with solid tumor cancer who have the microsatellite instability-high biomarker or mismatch repair deficient, and who are not eligible for surgery. The decision marks the first approval of a cancer drug based on genetic traits.
As Memorial Day approaches, we honor the brave men, women, and service animals who have given their lives for our country. We also recognize the thousands of veterans and war dogs who have returned from the battlefields in Iraq and Afghanistan with physical and psychological injuries.
Read FBR's latest blog post to see how these wounded heroes have access to a better quality of life than those in decades past, thanks to medical advancements made possible by animal research. Looking to the future, learn about the latest science and exciting new discoveries that may, for example, one day allow paralyzed veterans and service animals to walk again.
Bioverativ agreed to purchase True North Therapeutics in a deal worth up to $825 million, giving Bioverativ worldwide rights to True North's monoclonal antibody TNT009, indicated for the treatment of cold agglutinin disease. Bioverativ was spun off from Biogen earlier this year.
The FDA has granted breakthrough therapy designation to Achaogen's antibiotic plazomicin, intended to treat serious bacterial infections caused by multidrug-resistant Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae. Achaogen plans to file a new-drug application to the agency in the second half of this year.
Ultragenyx Pharmaceutical's biologics license application and marketing authorization application for its recombinant human beta-glucuronidase to treat metabolic disorder were accepted for review, and the drug was given priority review status by the FDA. The company also anticipates an opinion on the drug from the UK's Committee for Medicinal Products for Human Use in the first half of next year.
A Series C round of financing has raised $45 million for San Diego-based TP Therapeutics. The company expects data from a Phase I/II trial of its lead candidate, TPX-0005, which is being evaluated as a treatment for patients with advanced solid tumors harboring certain mutations, next spring.
Researchers at Duke University have developed a biotech rice variety that can activate the plant's defense system to fight off pathogens without stunting growth. Scientists added a TBF1 protein "cassette" to the NPR1 plant defense gene to ramp up the rice's immune system response to fight multiple pathogens at the same time.
An FDA committee determined that the biosimilar developed by Hospira is close enough to Amgen's anemia drug Epogen and could gain approval after an upcoming panel review. Regulators rejected the initial filing for the biosimilar made in 2015.
A new-drug application has been resubmitted to the FDA by Otsuka Pharmaceutical for its antidepressant Abilify, or aripiprazole, in combination with Proteus Digital Health's ingestible sensor, which allows transmission of psychological data to a patient-worn sensor and app. The FDA had requested more information regarding human factor studies after the company's original filing.
India-based Strides Shasun has been given FDA approval for its memantine hydrochloride tablets USP, 5 mg and 10 mg, for the treatment of moderate to severe Alzheimer-type dementia. The company's facility in Bengaluru, India, will produce the drug, while Strides Pharma will commercialize it in the US.
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