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. ...
Biocon and J&J Ustekinumab Settlement, and Biocon’s US Launch Planned for Feb 2025
On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch...
Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure
On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation...
Celltrion files Korean Application for CT-P47, Tocilizumab Biosimilar
On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s...
Celltrion’s Zymfentra® (SC infliximab) launched in US
On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with...
Akeso Announces Phase 2 Clinical Study Results for Cadonilimab
On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard...
FDA Grants Priority Review of AbbVie’s sBLA for EPKINLY® (epcoritamab SC)
On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its...