Pharmaceutical Business News

FDA approves new treatment for rare hereditary disease

The U.S. Food and Drug Administration recently approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE). HAE is a rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins in the body. This results in recurrent, unpredictable episodes of severe swelling in different areas of the
Pharmaceutical Business News

Set Back for Pancreatic Cancer: CARRIE study did not meet primary or secondary endpoints

Merrimack Pharmaceuticals, Inc., a clinical-stage oncology company focused on biomarker-defined cancers, today announced top-line results from the CARRIE study, a randomized Phase 2 trial evaluating the addition of MM-141 (istiratumab) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1). The study did not meet its primary or secondary efficacy endpoints in patients who received MM-141 in combination with
Cancer Discovery Immunotherapies

FDA Approves the Roll-Over Combination Study with Checkpoint Inhibitor Immunotherapies to Allow Continued Access to BriaVax™ in Patients with Advanced Breast Cancer

The FDA has approved the roll-over combination study of the investigational breast cancer vaccine, BriaVax™ with pembrolizumab {Keytruda; manufactured by Merck & Co., Inc. or ipilimumab {Yervoy; manufactured by Bristol-Myers Squibb Company for patients previously treated with BriaVax™ from the ongoing Phase I/IIa Clinical Trial in Advanced Breast Cancer. BriaVax™ is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune