Blog Archives | Page 38 of 101

Recent BioBlast® Updates

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

Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T

Jan 22, 2025

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), a 23% increase compared to 2023. According to the Korea Herald, this makes Samsung...

New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma

Jan 22, 2025

On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for...

UK’s NICE Recommends AstraZeneca’s Imfinzi® for SCLC

Jan 22, 2025

On 22 January 2025, PMLive reported that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Imfinzi® (durvalumab) in combination with chemotherapy