Recent BioBlast® Updates

New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU

Oct 23, 2024

On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with...

Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

Oct 23, 2024

On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult...

Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High

Oct 23, 2024

Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed KRW 3T for the first time and raising its annual revenue growth guidance to +15-20%. Samsung’s consolidated revenue reached KRW 1.2T for the quarter,...

Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B

Oct 22, 2024

On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical company. The contract extends until December 2037, with production to occur at Samsung Biologics’...

Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

Oct 22, 2024

On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal. That appeal concerns a September 2024 decision of the US...

Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List

Oct 22, 2024

On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list. The request aims to prevent compounding pharmacies from producing...

Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved

Oct 22, 2024

On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen's Stelara®. The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and...

Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

Oct 21, 2024

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol). On 21 October 2024, Xbrane announced it reached...

Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial

Oct 21, 2024

On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established...

Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia

Oct 21, 2024

On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection pre-filled syringe, 45 mg/0.5 mL solution for injection pre-filled syringe and 5 mg/1 mL...

Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)

Oct 18, 2024

On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME). The results were presented at the American Academy of...

PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU

Oct 18, 2024

On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its September 2024 intracycle meeting. This included consideration of proposals for broad Pharmaceutical Benefits Scheme (PBS) listings for PD-(L)1 inhibitors,...

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Recent BioBlast® Updates

New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU

Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High

Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B

Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List

Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved

Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial

Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia

Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)

PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU

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