Company (Symbol) Product Description Indication Action (Date)
Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) Remicade (FDAapproved) Infliximab; chimeric monoclonal antibody to tumor necrosis factoralpha Prevention of joint damage in patients with rheumatoid arthritis Priority review status granted (1/27); FDA s Arthritis Advisory Committee voted unanimously to recommend approval (7/12)
Millennium Pharmaceuticals Inc. (MLNM) and Ilex Partners LP (joint venture of Millennium and Ilex Oncology Inc.; ILXO) Campath Alemtuzumab; humanized monoclonal antibody Chronic lymphocytic leukemia Received a complete response letter for BLA delineating deficiencies (6/26); ILEX responded to BLA letter (8/21); The Oncologic Advisory Committee voted 14-to-1 to recommend accelerated approval of Campath (12/15)
Palatin Technologies Inc. (AMEX:PTN) and Mallinckrodt Inc. (NYSE:MKG) LeuTech Radiolabeled monoclonal antibody-based system for imaging infection Diagnosis of equivocal appendicitis BLA accepted for review (2/23); FDA scheduled advisory panel meeting for 7/10 (6/5); FDA s Medical Imaging Drugs Advisory Committee voted 8-0 to recommend the product for approval (7/10); FDA requested additional manufacturing and process-validation data for the BLA (9/28)