Compass Therapeutics, Inc, a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CTX-009, the company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract cancers (BTC) that have been previously treated.
It was a positive week for the European Medicines Agency’s human medicines committee (CHMP), which recommended the approval of eight new drugs including Takeda’s Fruzaqla and AstraZeneca’s Truqap.
A $4.9 billion hole has appeared in Gilead’s pipeline. After years of setbacks, the big biotech dealt a final blow to its anti-CD47 monoclonal antibody magrolimab Thursday by removing the remaining solid tumor trials from its pipeline.
After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition.
Shortly after winning a stay on a COVID-19 vaccine patent lawsuit brought by Moderna, Pfizer and its German partner BioNTech are being dragged into another round of mRNA litigation by GSK.
April 26 (Reuters) - The U.S. Food and Drug Administration approved Pfizer's (PFE.N), opens new tab gene therapy for hemophilia B on Friday, the second such therapy for the rare bleeding disorder that typically requires regular infusions of a blood-clotting protein.
April 26 (Reuters) - AbbVie (ABBV.N), opens new tab expects a drop in sales volumes of its blockbuster arthritis drug Humira to deepen after recent changes by U.S. pharmacy benefit managers and as patients shift to other drugs.
Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional surface.
In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and rare genetic disorder that affects a wide range of bodily systems, leading to severe cardiac, neurological, and psychiatric symptoms as well as physical differences such as webbed fingers and toes. The treatment restored typical cellular function in 3D structures created from cells of people with Timothy syndrome, known as organoids, which can mimic the function of cells in the body. These results could serve as the foundation for new treatment approaches for the disorder. The study, supported by the National Institutes of Health (NIH), appears in the journal Nature.