No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Dec 27, 2023
Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents. The Court published a short form judgment and concluded that: Mylan...
Dec 27, 2023
Formycon announced that the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept). On 29 November 2023, Regeneron sued Formycon in the US for infringement of 39 of its Eylea®...
Dec 27, 2023
The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada. The application includes all Xolair® indications, including allergic asthma, chronic...
Dec 26, 2023
Coherus Biosciences announced it received FDA approval for Udenyca OnBody® the on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection...
Dec 26, 2023
Celltrion announced in a corporate filing that its phase III clinical trial demonstrated that CT-P17, biosimilar to AbbVie’s Humira® (adalimumab), is interchangeable with Humira® in patients with plaque psoriasis. Celltrion plans to apply to the FDA for...
Dec 22, 2023
Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026. Clinical trials are in the final stages. Leqembi® was co-developed by Eisai and Biogen....
Dec 22, 2023
Biocon Biologics announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan. Biocon Biologics acquired the...
Dec 22, 2023
Daiichi Sankyo and MSD announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC)...
Dec 21, 2023
Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small...
Dec 20, 2023
The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent. The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings...
Dec 20, 2023
The Business Standard reported that AstraZeneca Pharma India said it will launch Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer in India in January 2024.
Dec 20, 2023
mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.