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
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 Merck (MSD) Report Positive Phase 3 Results for Olaparib in Early Breast Cancer
On 11 December 2024, AstraZeneca and Merck (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
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
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).
MSD’s Keytruda® Ph 3 Trial in Ovarian Cancer Meets Primary Endpoint
On 9 December 2024, MSD (known as Merck in the US and Canada) announced that its Phase 3 KEYLYNK-0001 trial for Keytruda® (pembrolizumab) plus chemotherapy, followed by maintenance with AstraZeneca’s Lynparza® (olaparib)…
Approval Alert: Celltrion’s Omalizumab Biosimilar First Approved in Canada
On 9 December 2024, Celltrion announced that Omlyclo® (CT-P39), biosimilar to Genentech/Novartis’ Xolair® (omalizumab) was approved by Health Canada. The approval is for all…
FDA Accepts Review for New COPD Indication of GSK’s Nucala®
On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for…
J&J Announces Promising Data for Darzalex Faspro® (Daratumumab and Hyaluronidase-fihj) and Tecvayli® (Teclistamab-cqyv)
On 8 December 2024, Johnson & Johnson (J&J) announced data showing that Darzalex Faspro® (daratumumab and hyaluronidase-fihj) )-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival
J&J Announces Positive Phase 3 Data for Darzalex Faspro®
On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing...
Novo Holdings’ Acquisition of Catalent Approved by European Commission
On 6 December 2024, Novo Holdings A/S, Novo Nordisk’s holding company, announced that the European Commission approved...
Pharmac Announces Funding of Four Additional Cancer and Respiratory Medicines
On 6 December 2024, New Zealand’s Pharmac announced that it would, in partnership with AstraZeneca, be providing...
Compounding Pharmacies Push Back on Novo Nordisk’s FDA Petition
In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable...
AstraZeneca’s sBLA for Imfinzi® Granted Priority Review
On 6 December 2024, AstraZeneca announced that its sBLA for Imfinzi® (durvalumab) has been granted Priority Review by...
CDSCO Panel Approves Zydus’ Safety Study of Pertuzumab Biosimilar
At a meeting on 5 December 2024, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) approved Zydus’ Sigrima®, biosimilar to Roche’s
Jazz Pharmaceuticals’ Ziihera® Recommended by US NCCN for Biliary Tract Cancer
On 5 December 2024, Jazz Pharmaceuticals’ announced that Ziihera® (zanidatamab-hrii) 50 mg/mL for injection for...