Biologics, also called biologicals, are drugs made from living things. Sometimes, these substances come from human donors, such as donated blood. Other times, they are grown in a laboratory. For example, scientists might grow a type of bacteria that makes a helpful substance. Then, they harves...
The advances that are being made in this industry are making it possible for companies to develop and manufacture biologic drugs more efficiently and cost-effectively. This is benefiting both pharmaceutical companies and patients. Top Biologics Contracts in 2023 Keytruda (pembrolizumab) is a ...
April Armstrong, MD, MPH, of University of California, Los Angeles, discussed how recent biologics advancements improved moderate-to-severe atopic dermatitis (AD) treatment.
These are essentially copycat biologics. They're made from the same sources, with the same benefits, strength, and dosage. The FDA has approved the biosimilars infliximab-axxq (Avsola), infliximab-dyyb (Inflectra), and infliximab-abda (Renflexis) to treat RA. But bear in mind that their ...
Are We T1-DONE? Kind of. At this point, the researchers wanted to know two things: what happens next and what makes this process specific to protein? The researchers found that the T1-DANs form a direct and dense connection with neurons in the protocerebral bridge, a part of the insect...
The FDA has since approved Cibinqo (abrocitinib) and Rinvoq (upadacitinib) for the treatment of refractory, moderate-to-severe atopic dermatitis in those whose disease is not well controlled with other systemic medications, including biologics.89Cibniqo and Rinvoq are approved for adults and chi...
Decisions on whether to approve or reject applications from vaccine makers are traditionally left up tocareer scientistsworking in the agency's Center for Biologics Evaluation and Research. That is mostly ensured only by norms, not law. "It's totally within the law for the president or the HHS...
One such application lies in quality control for biologics manufacturing. “Whether you’re developing an mRNA vaccine or a gene therapy, you’ll need to confirm that the construct you’re using and its transcribed products are made as you intended,” says Thermo Fisher application scientist Claud...
“For advanced therapies, the innovator companies are ahead,” Atkinson said. “You’re still teaching CDMOs. They might be trying to come up with platforms, but we’re still teaching them, and that wasn’t the case in small molecules or biologics.” That’s not to say that CDMOs are...
But one wonders: how is remdesivir made? Remdesivir (1) is a ProTide, a phosphoramidate prodrug of nucleoside GS-44154 (2), which consists of two parts: the ribose core and the unnatural base. Two generations of synthesis of remdesivir (1) have been reported by Gilead. ...