Five of Burroughs Wellcome's six patents for AZT (Retrovir, zidovudine) are valid, the D.C. federal appeals court ruled Nov. 22. The three-judge panel reviewed a July 1993 New Bern, N.C. federal court ruling that Wellcome was the sole inventor of AZT. The defendants in the New Bern case, Barr and Novopharm, claimed that the National Institutes of Health should also have been named as an inventor. "On the facts before us, it is apparent that the district court correctly ruled against Barr and Novopharm as to five of the patents" (numbers 4,724,232, 4,828,838, 4,833,130, 4,837,208 and 4,818,538), the appeals court said.
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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 FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.
A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.
