Foster City, Calif.-based biotech firm will receive $20 mil. in quarterly payments through 1997 from joint venture partner JT Immunotech to fund research of human monoclonal antibody products. The newly formed Xenotech Division will be funded with a total of approximately $40 mil. over the next four years to conduct preclinical research; Cell Genesys has North American rights to any products and Japan Tobacco has exclusive rights in Japan, Taiwan and Korea. The joint venture previously has provided Cell Genesys with $16 mil. since mid-1991, with another $8 mil. due in the next 18 months, for development of new strains of human monoclonal antibody-producing mice
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
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