We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental…
We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental…
Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative…
Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to…
As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11…
Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose…
As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade…
As we posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen….
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for…
Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and…
On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking…