Blog Archives | Page 36 of 99

Recent BioBlast® Updates

J&J’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease

Jan 8, 2025

On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab. Posdinemab is a phosphorylated tau-directed monoclonal antibody being investigated to treat patients with early Alzheimer’s disease in the Phase 2b “AuTonomy” study.

New Indication Alert: Astellas’ Padcev™ Combination Therapy Approved in China for Urothelial Cancer

Jan 8, 2025

On 8 January 2025, Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has approved its Padcev™ (enfortumab vedotin) in combination with Merck’s (known as MSD outside the US and Canada) Keytruda® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer.

Biocon’s Biosimilar Ustekinumab Approved in Japan

Jan 7, 2025

On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®. Biocon’s biosimilar ustekinumab will be commercialised and marketed in Japan by its exclusive commercial partner, Yoshindo Inc.

New Indication Alert: BeiGene’s Tevimbra® Receives New Indication Approvals in Australia and the US

Jan 6, 2025

On 6 January 2025, the Australian Therapeutic Goods Administration (TGA) approved an indication expansion for BeiGene’s Tevimbra® (tislelizumab) in combination with platinum-based chemotherapy for the first-line treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma.

Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in Australia

Jan 6, 2025

On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

New Indication Alert: GSK’s Nucala® Approved in China for CRSwNP

Jan 3, 2025

On 3 January 2025, GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala® (mepolizumab) as an add-on therapy with intranasal corticosteroids for the

Novo Nordisk Submits Citizen Petition Seeking to Block Compounded Victoza®

Jan 2, 2025

On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® (liraglutide) from a proposed list of drugs eligible for

Amgen’s Ustekinumab Biosimilar First to Launch in US

Jan 1, 2025

AIS Health reports that, on 1 January 2025, Amgen launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s private label subsidiary Nuvaila.

Sandoz’s High Concentration Adalimumab Biosimilar PBS-Listed

Jan 1, 2025

On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®.

New Indication Alert: J&J Receives EU Approval for Amivantamab Combination Treatment for NSCLC

Dec 30, 2024

On 30 December 2024, Johnson & Johnson (J&J) announced that the European Commission has approved a Type II variation extension of indication for its Rybrevant® (amivantamab) as

BMS’ Subcutaneous Nivolumab FDA-Approved

Dec 27, 2024

On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20). The approval covers most (but not all) previously approved adult, solid tumour Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

FDA Approves Global Phase 3 Trial for Celltrion’s Daratumumab Biosimilar

Dec 27, 2024

On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s