On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s...
Approval Alert: BeiGene’s Tevimbra® (Tislelizumab) Approved in New Zealand
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Approval Alert: Eisai Receives Mexican Approval of Lecanemab® for Early Alzheimer’s Disease
On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of...
FDA Approves Merus’ Bizengri® (Zenocutuzumab-zbco) as First Therapy for NRG1 Fusion Cancers
On 4 December 2024, Merus announced that the FDA has approved Bizengri® (zenocutuzumab-zbco) for adults with...
MSD’s Sac-TMT Granted ‘Breakthrough Therapy’ Designation in US
On 3 December 2024, Merck, known as MSD outside the US and Canada, announced that sacituzumab tirumotecan (sac-TMT)...
Shanghai Henlius’ NDA for Pertuzumab Biosimilar Accepted in China
On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta®...
FDA Accepts sBLA for Genentech/Roche’s Columvi® Combination Therapy
On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence...
FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ CRB-701
On 3 December 2024, Corbus Pharmaceuticals announced that the US FDA has granted Fast Track designation to CRB-701...
Approval Alert: Biocon’s Yesintek® Becomes Sixth Ustekinumab Biosimilar Approved in US
On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar...
J&J Submits sBLAs for Tremfya® for PsO and jPsA
On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications...
Update on Challenges to Regeneron’s US Aflibercept Formulation Patent
On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition closely followed a petition filed by Samsung Bioepis in relation to the same patent on 20 November 2024. Both petitions challenge the 865 patent for obviousness. Formycon has requested joinder of its petition with that of Samsung Bioepis.
Approval Alert: Intas Pharmaceutical Receives Approval to Manufacture and Market Biosimilar Pertuzumab in India
India’s Medical Dialogues reports that Intas Pharmaceuticals has received approval from the Subject Expert Committee...
China Adds Enhertu® to Health Insurance Plan
On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be...
Pfizer’s Infliximab, Sandoz’s Natalizumab & Samsung Bioepis’ Ustekinumab on Australia’s PBAC March 2025 Agenda
On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025...
Eisai Korean Launch of Leqembi for Alzheimer’s Disease
On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment...
Celltrion Phase 3 Clinical Trials for Daratumumab, Biosimilar To Janssen’s Darzalex®
On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to...
New Indication Alert: European Commission Approves BeiGene’s Tevimbra® (Tislelizumab) for ESCC and G/GEJ
On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination...