Recent BioBlast® Updates

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).

EMA Adopts Positive Opinion for Novo Nordisk’s Ozempic®

Dec 12, 2024

On 12 December 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the…

Cipla Loses Challenge to Extended Term of Novo Nordisk’s AU Liraglutide Formulation Patent

Dec 12, 2024

On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862).

CHMP Positive Opinions for CSL, Galderma & AstraZeneca; Expanded Indications for Amgen, GSK & Eli Lilly

Dec 12, 2024

At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab) for prevention of recurrent attacks of hereditary angioedema (HAE).

FDA Accepts Hikma/Richter’s Biosimilar Denosumab Application

Dec 12, 2024

On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.

Celltrion’s Aflibercept, Denosumab and Tocilizumab Biosimilars Among Six to Receive Positive CHMP Opinions

Dec 12, 2024

At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.

AstraZeneca and MSD Report Positive Phase 3 Results for Olaparib in Early Breast Cancer

Dec 11, 2024

On 11 December 2024, AstraZeneca and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) announced positive results for Lynparza® (olaparib) in the treatment of breast cancer, as

China Accepts for Review GSK’s Blenrep® Combination Treatment; GSK Announce Further Positive Data

Dec 9, 2024

On 9 December 2024, GSK announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a treatment for relapsed or refractory multiple myeloma (RRMM).

MS Pharma & Formycon Partner to Commercialise Biosimilar Ustekinumab in MENA

Dec 9, 2024

On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), in the Middle East and North Africa (MENA).

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Recent BioBlast® Updates

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

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

Sanofi Secures Continued PBS Listing of Dupixent®

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

EMA Adopts Positive Opinion for Novo Nordisk’s Ozempic®

Cipla Loses Challenge to Extended Term of Novo Nordisk’s AU Liraglutide Formulation Patent

CHMP Positive Opinions for CSL, Galderma & AstraZeneca; Expanded Indications for Amgen, GSK & Eli Lilly

FDA Accepts Hikma/Richter’s Biosimilar Denosumab Application

Celltrion’s Aflibercept, Denosumab and Tocilizumab Biosimilars Among Six to Receive Positive CHMP Opinions

AstraZeneca and MSD Report Positive Phase 3 Results for Olaparib in Early Breast Cancer

China Accepts for Review GSK’s Blenrep® Combination Treatment; GSK Announce Further Positive Data

MS Pharma & Formycon Partner to Commercialise Biosimilar Ustekinumab in MENA

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