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Latest From Legal Issues
Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.
A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.
Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.
During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.
Tribunal finds Lilly did not prove that Canada's promise utility doctrine discriminates against pharmaceutical patents; 25 pharma patents have been invalidated in past decade.
Minnesota Attorney General demands Novo Nordisk and Sanofi provide information on their insulin pricing; they are also among several companies facing probes over their contracts with pharmacy benefit managers.
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