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Recent BioBlast® Updates

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).

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Recent BioBlast® Updates

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

MSD’s Keytruda® Ph 3 Trial in Ovarian Cancer Meets Primary Endpoint

Approval Alert: Celltrion’s Omalizumab Biosimilar First Approved in Canada

FDA Accepts Review for New COPD Indication of GSK’s Nucala®

J&J Announces Promising Data for Darzalex Faspro® (Daratumumab and Hyaluronidase-fihj) and Tecvayli® (Teclistamab-cqyv)

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