On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit...
Celltrion Submits BLA for Interchangeable Omalizumab (Xolair®) Biosimilar
Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval...
Approval Alert: Formycon AG / MS Pharma’s Ranibizumab Biosimilar (Ravegza®) Approved in Saudi
On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s...
J&J Submits sBLA to FDA for TREMFYA® (guselkumab)
On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application...
Merck (MSD) Completes Acquisition of Harpoon Therapeutics for ~USD$650M
On 11 March 2024, Merck (MSD) announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M...
Approval Alert: MSD’s Keytruda® (pembrolizumab) Approved in Korea for HER2-negative Gastric Cancer
On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda...
Approval Alert: FDA Approves Regeneron’s Praluent® (alirocumab) Injection for Treating Children with Genetic Form of High Cholesterol
On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children...
Eli Lilly’s ADmirable Lebrikizumab Study Shows Positive Results
On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study. This is the first-of-its-kind...
Samsung Bioepis Presents Interchangeability Updates for its Adalimumab and Ustekinumab Biosimilars at AAD
On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024...
NEW INDICATION ALERT: FDA Approves Novo Nordisk’s Wegovy® (semaglutide) for Cardiovascular Risk Reduction
Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse...
Regeneron’s High Dose Eylea® (aflibercept) With Extended Dosing Intervals May Reduce Treatment Burden
Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s...
NEW INDICATION ALERT: J&J Submits EMA Application for DARZALEX® (daratumumab) SC for Multiple Myeloma
On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European...
Approval Alert: FDA Approves BMS’s Opdivo (nivolumab) in Combination with Cisplatin and Gemcitabine for Metastatic Urothelial Carcinoma
On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults...
Janssen Moves to Dismiss Insurers’ Stelara® Class Action
Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health...
Fresenius Announces First Subcutaneous Tocilizumab Biosimilar Approved in the US
On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®,...
Sandoz Announces First US Denosumab Biosimilars Approved with Interchangeability
On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz's Wyost® and Jubbonti®. The...