Granted Sept. 6 to the inventors of the vaccine at the University of California, San Francisco and at the University of Washington. Patent covers the hepatitis B surface antigen produced from genetically engineered yeast and the Recombivax HB vaccine. In December 1987, Biogen received a patent covering the manufacture of "all hepatitis B surface and core antigens produced by genetic engineering." Biogen's technology is licensed to SmithKline ("The Pink Sheet" April 11, T&G-4). Merck maintains that any recombinant vaccine for hepatitis B produced through genetically engineered yeast falls under the claims of its patent.
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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 Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
