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...
Study Finds that LG Chem’s Biosimilar LBEC0101 is Comparable to Pfizer & Amgen’s Enbrel (Etanercept) for Treatment of Patients With Rheumatoid Arthritis
On 5 March 2024, a study published in Modern Rheumatology found that LG Chem's LBEC0101, the biosimilar of etanercept,...
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...
Novo Nordisk Ozempic® (Semaglutide 1.0) Study Demonstrates Reduction in Kidney Disease Events
Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes. In this study,...
Indian Launch of Roche’s $2.7 Billion Blockbuster Vabysmo® (faricimab)
On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of...
Phase II Clinical Trials Show Positive Results for FKB238 (bevacizumab biosimilar), Olaparib, and Durvalumab Combination for Treatment of Ovarian Cancer
A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by...
Sandoz Completes Acquisition of Coherus’s CIMERLI® (ranibizumab biosimilar)
On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus...
Amgen Launches Second Stelara® (ustekinumab) Biosimilar in Canada
Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for...
Biocon Settles Aflibercept Dispute with Regeneron & Bayer; Announces Canadian Launch Date
Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept),...
A Second Challenge by Merck Against Four Johns Hopkins Pembrolizumab MOT Patents
On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents...