
Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with...
By Seth Cockrum Comments are off
Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with...
Tagged with: Aimovig™, Alder Biopharmaceuticals, Amgen, Eli Lilly, eptinezumab, erenumab, FDA, fremanezumab, galcanezumab, News, Novartis, Teva
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By Seth Cockrum Comments are off
Last week, Novartis and Amgen announced the FDA approved Aimovig™ (erenumab) for the preventive treatment of migraine in adults. The...
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By Spencer Johnson Comments are off
As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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By Seth Cockrum Comments are off
Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by...
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By Seth Cockrum Comments are off
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...
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By Aydin Harston Comments are off
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB
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By D. Lawson Allen Comments are off
On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central...
Tagged with: Amgen, Avastin®, bevacizumab, bevacizumab-awwb, BPCIA, Genentech, Mvasi
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By Nicole DeAbrantes Comments are off
On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s...
Tagged with: Amgen, Amicus Brief, Bavarian Nordic, Bristol-Myers Squibb, District Court, En banc, Enzo Biochem, Federal Circuit, Inc., Praluent®, Regeneron, Sanofi
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By Caitlin M. Wilmot Comments are off
On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
Tagged with: Amgen, Amgen v. Sandoz, BPCIA, FDA, Federal Circuit, filgrastim, Neupogen®, Sandoz
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