Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Dean Rudge
Growing its portfolio of established brands and expanding its product range through the acquisition of non-regulated brands are at the top of Adcock Ingram’s wish-list in 2019, as the company grapples with what it feels is a “low” increase in South Africa’s single exit price and tough trading conditions in certain channels. Nevertheless, it saw a “sound” financial performance in the six months to 31 December 2018.
Canadian Authorities Say Janssen Did Not Choke Competition For Infliximab – But Will Keep Spotlight On Originator Abuse Of Power
In contrast to a US court, the competition authority in Canada has not found evidence that Janssen abused its power in the infliximab market and unlawfully stymied competition from Pfizer’s and Merck’s biosimilars. However, given the relative immaturity of the Canadian biosimilars market, the Competition Bureau said it would continue to watch closely as the market develops.
Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the US Federal Trade Commission that dismisses Teva and its affiliates from three outstanding antitrust cases.
In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.
Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after receiving a target goal date of 7 October 2019 from the FDA.