On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across...
Two New Gynaecological Cancer Indications for MSD’s Keytruda® in Europe
On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European...
Biocon Switching Study for Aflibercept Confirms Safety & Efficacy
On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s...
New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU
On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication...
Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed
On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines...
Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High
Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed...
Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B
On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24...
Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk
On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled...
Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List
On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to...
Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved
On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™...
Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars
In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and...
Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial
On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which...
Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia
On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to...
Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)
On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from...
PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU
On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its...
Approval Alert: FDA Approves Astellas Pharma’s Zolbetuximab
On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) in combination with...