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The patent includes claims to protect the use of a clinical-stage drug candidate BL-8040’s composition for improving immune responses to an antigen, such as a tumor-associated antigen. The

The pivotal Phase III POISE trial showed that OCA, at both a 10mg dose and a 5mg dose titrated to 10mg, met the trial’s primary endpoint of achieving

The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as

Pfizer Global Innovative Pharmaceuticals Business Medicines Development Group head and senior vice president Dr Steven J Romano noted as the number of hip and knee replacement surgeries performed

SmartFactory is a single-use cGMP bio-manufacturing capacity, which will allow Alvotech to rapidly expand its biosimilars business. Finesse’s customers will benefit from unprecedented access to Alvogen’s commercial, the

TrialMaster EDC was selected in part for its Custom Data Export Utility. This enables compliance with the US Food and Drug Administration’s (FDA), soon to be mandated, requirement

The FDA guidance provides that the highest allowed dose will be 12mg daily. Repros is currently conducting a Phase II study for the use of Proellex in severe

Three of the four molecules it has designed are potent inhibitors of both cyclooxygenase-2 (COX-2) and COX-1 enzymes. The fourth inhibits COX-2 but only weakly inhibits COX-1. Simulations

The company said that the new purification facility will expand its capacity to produce active pharmaceutical ingredients (APIs) for a growing number of diabetes drugs under development. The