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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
