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European Committee for Proprietary Medicinal Products recommends the approval of Centoxin (Nebacumab) , a drug originally developed by Henry Kaplan and Nelson Tang at Stanford University and prepared for market by Centocor. Based on this recommendation the drug was subsequently approved for market in The Netherlands, Britain, Germany and France between March and December 1991.1991-03-01T00:00:00+0000| Mar 1991 | | Monoclonal antibody drug approved in Europe for the treatment of septic shockKaplan, Tang | Stanford University Medical School, Centocor | Monoclonal antibodies |
Heidelberger was one of the founders of immunochemistry, a branch of biochemistry that investigates the mammalian immune system at the molecular level. He first made his mark in 1923 when he found, with Oswald Avery, that the immune system could target bacterial sugars. The two scientists made the discovery while investigating a capsular substance that envelops pneumococcus and other species of bacteria. Their work helped determine that antibodies were proteins. It also paved the way to improving the production of more effective serum therapies for the prevention of bacterial infectious like pneumonia and meningitis.1991-06-25T00:00:00+0000| 25 Jun 1991 | | Michael Heidelberger died in New York City, USAHeidelberger | Rockefeller Institute, Columbia University | Antibodies, Immunology |
Developed to treat Gram-negative sepsis, Centoxin originated from research conducted by Henry Kaplan and Nelson Teng based at Stanford University. It was licensed to Centocor, a small biotechnology company in Philadelphia. Following the FDA's request for more information, Centocor watched US$1.5 billion of its market capitalisation disappear. The news also had a devastating impact on other companies developing monoclonal antibody drugs. 1992-02-20T00:00:00+0000| Feb 1992 | | Monoclonal antibodies market crashed following FDA's call for more information for Centocor's drug, CentoxinSchoemaker, Koprowski, Milstein | Centocor, Wistar | Monoclonal antibodies |
Interim trial data from trials show unexpectedly high mortality from Centoxin, leading to withdrawal of the drug from the European market. Reinforces general pessimism about the future for monoclonal antibody drugs. 1993-02-01T00:00:00+0000| Feb 1993 | | Centoxin withdrawn from European market | Centocor | Monoclonal antibodies |
Three groups of scientists separately report the successful generation of different strains of transgenic mice for the generation of human monoclonal antibodies. Two of the teams are based in biotechnology companies: GenPharm (led by Nils Lonsberg), Cell Gensys (led by Larry Green) , and the other involved a collaboration (led by Marian Bruggemann and Michael Neuberger) between scientists at the Laboratory of Molecular Biology, Braham Institute and the University of Cologne.1994-01-01T00:00:00+0000| 1994 | | First transgenic mice strains reported for producing human monoclonal antibodiesBruggemann, S.Green, Lonsberg, Neuberger | Cell Genesys, GenPharm, Laboratory of Molecular Biology | Monoclonal antibodies, Transgenic animals, Cloning |
Jerne shared the 1984 Nobel Prize for Medicine for 'theories concerning the specificity in development and control of the immune system'. He developed three important theories for immunology. Firstly, that antibodies are formed during fetal development and are present in the body from birth. Secondly, that white blood cells, lymphocytes, teach themselves to recognise the body's own substances in the thymus gland. Thirdly, he proposed the network theory which depicts the immune system as a complex self-regulating network that can turn itself on and off when needed. Jerne's work paved the way to development of monoclonal antibodies. He was the founder and director of the Basel Institute of Immunology.1994-10-07T00:00:00+0000| 7 Oct 1994 | | Niels Kaj Jerne diedJerne | Basel Institute for Immunology | Immunology, Monoclonal antibodies |
Abciximab (ReoPro) approved by the FDA and European regulatory authorities to prevent blot clots during coronary artery procedures like angioplasty. The monoclonal antibody was originally developed by Barry Coller at State University of New York and commercially developed by Centocor. The drug showed for the first time that monoclonal antibodies could be used for the treatment of acute disease conditions. 1994-12-22T00:00:00+0000| 22 Dec 1994 | | First chimeric monoclonal antibody therapeutic approved for marketColler, Schoemaker | Centocor, State University of New York | Monoclonal antibodies, Recombinant DNA |
German regulatory authorities approve Panorex as an adjuvant therapy, that is a drug given in addition to primary or main treatment, for postoperative colorectal cancer. The drug originated from resesearch undertaken by Hilary Koprowski and his colleagues at the Wistar Institute. 1995-01-01T00:00:00+0000| 1995 | | First monoclonal antibody drug for cancer approved in EuropeKoprowski | | Monoclonal antibodies |
German regulatory authorities approve edrecolomab (Panorex) as an adjuvant treatment for post-operative colorectal cancer. The monoclonal antibody, originally known as 17-1A, was developed at the Wistar Institute and commercially developed for market by Centocor. 1995-01-01T00:00:00+0000| 1995 | | First monoclonal antibody therapeutic for cancer approved for marketKoprowski | Wistar Institute, Centocor | Monoclonal antibodies |
Together with Cesar Milstein, Kohler developed the first unlimited supply of long-lasting monoclonal antibodies. Their technique now underpins the development and application of many diagnostics and therapeutics. Kohler and Milstein devised the method as part of their search for a tool to investigate how the immune system can make so many different kinds antibodies, each able to bind to a highly specific receptor on foreign substances that invade the body. 1995-03-01T00:00:00+0000| 1 Mar 1995 | | Georges Kohler diedKohler | Laboratory of Molecular Biology | Monoclonal antibodies |
Ritxuan (rituiximab) is approved for the treatment of non-Hodgkin Lymphoma. The drug arose out of Ronald Levy's research for three decades to find a way of harnessing the power of the body's own immune system to fight cancer.
1997-01-01T00:00:00+0000| 1997 | | FDA approved the first monoclonal antibody cancer drug for the American marketLevy, Rastetter | Stanford University Medical School, Idec Pharmaceuticals | Cancer immunotherapy, Monoclonal antibodies |
Koshland was an American immunologist who was a major pioneer in the field of antibodies. Her work was instrumental in showing antibodies to be discrete entities and knowledge about the origins of antibody specificity. In the 1960s, she demonstrated that the efficiency and effectiveness with which antibodies can combat foreign invaders is determined by their different amino acid compositions. By the 1990s she had unravelled the process that accompanies and directs B cell activation and maturation. A major role-model for other women scientists, Koshland was nearly not awarded her PhD because her professor thought it would be a waste because she was pregnant. 1997-10-28T00:00:00+0000| 28 Oct 1997 | | Marian E Koshland diedKoshland | Brookhaven National Laboratory | Immunology, Antibodies |
Daclizumab was approved by the FDA for the prevention of acute rejection of kidney transplants. The monoclonal antibody was developed by Protein Design Labs using a humanising method devised by Cary Queen and marketed together with F. Hoffmann-La Roche. 1997-12-01T00:00:00+0000| Dec 1997 | | First humanised monoclonal antibody approved for marketQueen | Protein Design Labs, Roche | Monoclonal antibodies, Recombinant DNA |
The drug is a monoclonal antibody that targets cancer cells that overproduce the HER2/neu oncoprotein1998-01-01T00:00:00+0000| 1998 | | FDA approved Trastuzumab (Herceptin) for the treatment of metastatic breast cancer
| | Monoclonal antibodies, Oncology |
The company was set up by Perry Fell and Clay Siegall. The two scientists founded Seattle Genetics after their former employer, Bristol-Myers Squibb cuts its antibody cancer research programme.1998-01-01T00:00:00+0000| Jan 1998 | | Seattle Genetics founded
Fell, Siegall | Seattle Genetics | Monoclonal antibodies, Oncology |
1998-01-01T00:00:00+0000| 1998 | | Seattle Genetics licensed patents from Bristol-Myers Squibb | Seattle Genetics | Monoclonal antibodies, Oncology |
Remicade (infliximab) is approved for the treatment of Crohn's disease. Soon after Remicade wins approval for other autoimmune and inflammatory conditions including rheumatoid arthritis and ulcerative colitis. The drug, a monoclonal antibody against TNF alpha, a powerful promoter of inflammation, was developed in 1989 by Jan Vilcek and Jumning Le and developed in collaboration with Centocor, Marc Feldmann and Maini1998-08-01T00:00:00+0000| Aug 1998 | | FDA and European regulatory authorities approved the first monoclonal antibody drug for an autoimmune diseaseVilcek, Le, Feldmann, Maini, Schoemaker | New York University, Centocor, Kennedy Institute of Rheumatology | Monoclonal antibodies |
Genentech agreed to help Seattle Genetics develop SGN-40, one of its drugs for CD40 positive cancers. Under the deal Genentech made an upfront payment of $60 million to Seattle Genetics and agreed to make milestone payments in excess of $800 million and double-digit royalties on any sales.1999-01-01T00:00:00+0000| 1999 | | Seattle Genetics and Genentech partnership signed | Seattle Genetics, Genentech | Monoclonal antibodies, Oncology |
Launched by the biotechnology company Medarex in collaboration with Jim Allison. 2000-01-01T00:00:00+0000| 2000 | | First clinical trials launched to test first immune checkpoint inhibitor drug containing a monoclonal antibody against CTLA-4 (ipilimumab, Yervoy®)Allison | Medarex, University of California Berkley | Immune checkpoint inhibitors, Immunology, Cancer immunotherapy, Oncology, Monoclonal antibodies |
Michael Smith shared the 1993 Nobel Prize for Chemistry for a technique that enables researchers to introduce specific mutations into genes and, thus, to the proteins that they encode. He developed the method, known as site-directed mutagenesis, in the 1970s, in collaboration with Fred Sanger and Clyde A Hutchinson III. The advantage of the technique was that it allowed comparisons to be made of different protein molecules and provide a means to deliberately alter a specific gene thereby making it possible to modify the characteristics of an organism. His work opened up a new chapter for studying and treating genetic diseases. Site-directed mutagenesis is a pivotal tool today in genetic and protein research and engineering and at the forefront of the development of monoclonal antibody drugs.
2000-10-04T00:00:00+0000| 4 Oct 2000 | | Michael Smith diedMichael Smith | University of British Columbia | Gene editing, Genetics, Monoclonal antibodies |
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