As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s…
As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s…
As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory…
On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief….
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s…
On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA…
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…