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Apotex Inc.

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Latest From Apotex Inc.

Canadian Originators Are Free To Try Again

Having unsuccessfully asserted a patent under the previous legal framework in Canada does not preclude an originator from trying again following legislative amendments enacted in 2017, the country’s Federal Court of Appeal has ruled in a decision on Pfizer’s Nivestym filgrastim biosimilar.

Canada Intellectual Property

Some Pointers From The US FDA On How To Conduct Better Out-Of-Spec Investigations

Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.

 

Manufacturing Quality

Australian Price Cuts Keep On Coming

Lamivudine combinations with zidovudine, as well as ezetimibe, bosentan and infliximab were among the drugs in the crosshairs for Australian reimbursement price cuts from 1 October.

 

Australia Reimbursement

Apotex Suffers Adverse Tarceva Reversal

Apotex has seen last years decision that a patent protecting the Tarceva erlotinib oncology brand until 2021 was obvious overturned by a US Court of Appeals.

Intellectual Property Cancer
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