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Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.

Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487.  The petitioners argue that the ‘487 patent is invalid on novelty grounds.  Earlier this month Sanofi and Regeneron filed a complaint in the District Court of...

EMA approves Amgen’s biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.

Sanofi-Aventis, Genzyme Corporation and Regeneron filed a complaint in the District Court of Massachusetts seeking a declaration judgement that its development, manufacturing, sale, promotion and related activities for Dupixent® (dupilumab) do/will not directly or indirectl...

Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).

UK High Court hands down decision in Samsung v Abbvie.

PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents IPR2016-01771 (Patent 7,622,115) and IPR2016-01837 (Patent 7,807,799) from requests filed 9 September 2016.

Judge Sleet dismissed Genentech’s suit filed 15 Feb 17 (see below) under Fed Cir’s finding in Amgen v Sandoz.

Mundi’s biosimilar rituximab (Truxima®, developed by Celltrion) approved by EMA, and intended for launch in the UK, Germany, Italy, Netherlands, Belgium, Ireland and Luxembourg.