Reston, VA — PET/MRI can improve diagnostic accuracy for prostate cancer patients and help avoid unnecessary biopsies, according to new research published in the April issue of The Journal of Nuclear Medicine. By applying the PRIMARY scoring system to PET/MRI results, researchers found that more than 80 percent of unnecessary biopsies...
Latest News
NEW YORK & MIAMI – Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for...
NEW YORK, NY — Pfizer Inc.(NYSE: PFE) today announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival...
Pfizer has agreed to acquire Seagen, a global biotech focused on developing cancer treatments, for $43 billion. The announcement comes just a couple of weeks after the Wall Street Journal reported that the two companies were in talks. Both boards have approved the transaction, which is expected to close in...
New York, NY – The novel hemophilia therapeutic marstacimab has been accepted for submission by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for regulatory approval, according to a news release. Pfizer announced in a news release that the Biologics License Application (BLA) for its...
New York, NY – Health Canada on Wednesday approved Pfizer’s gene therapy fidanacogene elaparvovec, now to carry the brand name Beqvez, for the treatment of adults with hemophilia B. Beqvez is an adeno-associated virus-based gene therapy that delivers a functioning and high-activity copy of the human coagulation FIX gene, which...
DAEJEON, South Korea — PharmAbcine Inc., a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced today the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors. PMC-309 is an IgG1 monoclonal antibody with specific binding to VISTA in...
DAEJEON, South Korea — PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, announces the publication of preclinical research in Science Advances, highlighting the potential of its Tie2-activating antibody program, PMC-403, in treating Idiopathic Systemic Capillary Leak Syndrome (ISCLS). The results underscore the...
BURLINGTON, Mass.- PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for...
BURLINGTON, Mass. – PharmaEssentia USA Corporation, a subsidiary of Taiwan-based PharmaEssentia Corp. (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration...