The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry. Goodwin is a…
On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates awarding as many as five proposals up to $1 million in funding. This FOA arises…
Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes review on U.S. Patent Nos. 7,521,052 (“the ’052 patent”) and 10,744,201 (“the ’201 patent”) on June 28, 2021. …
On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy. The sNDA is based on…
On Friday, October 22, 2021, Judge Raymond A. Jackson of the Eastern District of Virginia (E.D. Va.) transferred Alvotech USA and Alvotech hf.’s (jointly, “Alvotech”) declaratory judgment suit against AbbVie Inc. and AbbVie Biotechnology Ltd. (jointly, “AbbVie”) to the Northern District of Illinois (N.D. Ill.) and dismissed AbbVie’s pending motion…
On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration. FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases. If approved, Coherus…
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and Avastin. Although Jordanov and Lin initially pled not guilty, the former JHL employees later admitted to hiring…
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding Remicade (infliximab). Remicade is an immunosuppressant that is used to treat Crohn’s disease,…
In the long-awaited decision in United States v. Arthrex, Inc., the U.S. Supreme Court confirmed that the Patent Trial and Appeal Board is unconstitutionally structured, but held that the correct remedy is more limited than the one the U.S. Court of Appeals for the Federal Circuit had granted. Instead of…
As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company. This month, Merck completed the spinoff, creating Organon. Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets. Organon…