Blog Archives | Page 40 of 102

Recent BioBlast® Updates

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Approved in Australia

Jan 29, 2025

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine

US Appeals Court Refuses to Overturn Injunctions Against Samsung Bioepis’ and Formycon’s Aflibercept Biosimilars

Jan 29, 2025

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from

New Indication Alert: AstraZeneca/Daiichi Sankyo’s Enhertu® FDA Approved for Breast Cancer

Jan 28, 2025

On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable

New Indication Alert: FDA Approves Novo Nordisk’s Ozempic® for Kidney Disease

Jan 28, 2025

On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure

Eisai/Biogen’s Leqembi® FDA Approved for Monthly IV Maintenance Dosing; Under Further Consideration in EU

Jan 28, 2025

On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab)

FDA Approves Eisai/Biogen’s Leqembi® IV Maintenance Dosing for Early Alzheimer’s Disease

Jan 27, 2025

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. The sBLA...

Alvotech/Teva’s BLAs for Biosimilar Golimumab First to be Accepted by FDA

Jan 27, 2025

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of...

Approval Alert: CSL Receives UK Approval for Garadacimab

Jan 24, 2025

On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.

Australia’s TGA Approves CSL’s Garadacimab in World First

Jan 24, 2025

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor...

Amgen and Celltrion Settle US Denosumab Litigation

Jan 24, 2025

Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries

Jan 23, 2025

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany. Steqeyma® was launched in France on 20 January 2025, Italy and Spain in...

FDA Grants Orphan Drug Designation for Zai Lab’s ZL-1310 for SCLC

Jan 22, 2025

On 22 January 2025, Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate, for the