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.
Mar 11, 2024
Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab). Celltrion’s application seeks approval for all Xolair® indications, as...
Mar 11, 2024
On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases...
Mar 11, 2024
On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. The product is currently approved in...
Mar 11, 2024
On 11 March 2024, MSD announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M with the aim of augmenting and diversifying their oncology pipeline. Harpoon’s lead candidate is MK-6070 and its safety, tolerability and pharmacokinetics...
Mar 11, 2024
On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based...
Mar 11, 2024
On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024. The approval was based on Phase 3 randomized trials in patients aged 8-17. The results,...
Mar 10, 2024
On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study. This is the first-of-its-kind study of lebrikizumab specifically designed to treat people with moderate-to-severe atopic dermatitis. This is also commonly known as eczema. The...
Mar 9, 2024
On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States. For its Humira® biosimilar...
Mar 8, 2024
Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). The...
Mar 8, 2024
Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet...
Mar 6, 2024
On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medicines Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with...
Mar 6, 2024
On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma. Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.