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...
Authorities raid Como Compounding Pharmacy in Melbourne and Seize Semaglutide
The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in...
First Biosimilar Launch: JAMP Pharma Launches Alvotech-Developed Jamteki™ (ustekinumab) in Canada
On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in...
UK health regulator issues safety update on Dupixent (dupilumab) side effects
The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects. ...