On 6 December 2024, New Zealand’s Pharmac announced that it would, in partnership with AstraZeneca, be providing...
Pharmac Announces Funding of Four Additional Cancer and Respiratory Medicines
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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...
Approval Alert: BeiGene’s Tevimbra® (Tislelizumab) Approved in New Zealand
On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s...
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...