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J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

by Bioblast Editor | Jan 9, 2025

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. J&J submitted a Biologics Licence Application (BLA) to the FDA seeking approval for this indication in August 2024.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Biocon’s Biosimilar Ustekinumab Approved in Japan

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Novo Nordisk Submits Citizen Petition Seeking to Block Compounded Victoza®

by Bioblast Editor | 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

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Amgen’s Ustekinumab Biosimilar First to Launch in US

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Sandoz’s High Concentration Adalimumab Biosimilar PBS-Listed

by Bioblast Editor | 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®.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

BMS’ Subcutaneous Nivolumab FDA-Approved

by Bioblast Editor | 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.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

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

by Bioblast Editor | 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

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Hikma’s Generic Version of Novo Nordisk’s Diabetes Drug Victoza® Approved and Launched in US

by Bioblast Editor | Dec 26, 2024

On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage form.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Bio-Thera & Tabuk Pharmaceuticals Seal Saudi Arabian Licensing Deal for Ustekinumab Biosimilar

by Bioblast Editor | Dec 24, 2024

On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®.

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Biocon Receives EU Approval for Generic Liraglutide

by Bioblast Editor | Dec 24, 2024

On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union. The approval is for the generic versions of Novo Nordisk’s Victoza®, to treat type-2 diabetes, and Saxenda®, used in the treatment of weight management.

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