On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be...
China Adds Enhertu® to Health Insurance Plan
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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...
New Indication Alert: Novo Nordisk’s Wegovy® Approved in Canada
On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide) for the reduction of...
Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA
On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for...
Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar
On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech's and Novartis' Xolair® (omalizumab) was approved...
New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India
On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India's Central Drugs...
FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma
On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab...
New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children
On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan®...
J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis
On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking...
Celltrion Denosumab Biosimilars First to be Approved in Korea
On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™...
Replimune Submits BLA for RP1 with Nivolumab for Melanoma
On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for...
JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)
We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara®
Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer
On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera®...