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Recent BioBlast® Updates

UPC Eculizumab Litigation Update: Preliminary Injunctions Against Samsung Bioepis and Amgen Denied by Court of Appeal

Dec 20, 2024

On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) in the EU. Alexion had originally filed the proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking preliminary injunctions for alleged infringement of EP 3 167 888 (method of treating paroxysmal nocturnal hemoglobinuria).

Fresenius & SamChunDang Exclusive US & LATAM Licence for Aflibercept Biosimilar

Dec 20, 2024

On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise

New Zealand’s Pharmac Seeks Feedback on Funding Proposals for BMS’ Opdivo® & Yervoy®, and Pfizer’s Besponsa®

Dec 19, 2024

On 19 December 2024, New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines for cancer and antibiotic resistant infections from 1 April 2025, which includes:

Originators Dominate PBAC’s May 2025 Agenda

Dec 18, 2024

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.

Gilead’s Trodelvy® (Sacituzumab Govitecan-hziy) Granted FDA Breakthrough Therapy Designation

Dec 17, 2024

On 17 December 2024, Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult

Approval Alert: Eli Lilly’s Kisunla® (Donanemab) Approved in China

Dec 17, 2024

On 17 December 2024, Eli Lilly announced that China’s National Medical Products Administration (NMPA) has approved its donanemab-azbt Kisunla® (350 mg/20 mL every four weeks injection for IV infusion)

J&J Submit sBLA for Simponi® (Golimumab)

Dec 16, 2024

On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for

GSK’s Jemperli® (Dostarlimab) receives US FDA Breakthrough Therapy Designation

Dec 16, 2024

On 16 December 2024, GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli® (dostarlimab) for the treatment of patients with locally advanced mismatch

CRL for J&J’s Subcutaneous Rybrevant® (Amivantamab)

Dec 16, 2024

On 16 December 2024, Johnson & Johnson (J&J) announced that the US FDA issued a Complete Response Letter (CRL) for its US Biologics License Application (BLA) for a fixed subcutaneous…

Approval Alerts: Accord and Celltrion’s Ustekinumab Biosimilars Approved in EU and US, Biocon Receives EU Recommendation

Dec 15, 2024

On 15 December 2024,  Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of

Sanofi Secures Continued PBS Listing of Dupixent®

Dec 14, 2024

The Australian Government has reached an agreement with Sanofi and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to ensure Dupixent® (dupilumab) remains listed on the Pharmaceuticals Benefits Scheme (PBS) for eczema treatment, as it has been since 2021

Roche’s Vabysmo® (Faricimab) PFS Approved in EU

Dec 13, 2024

On 13 December 2024, Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6mg) for treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO).