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Nov 28, 2024
On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD). The product was approved by Korea’s...
Nov 28, 2024
On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to Janssen’s Darzalex® (daratumumab), following submission of its global phase 3 clinical trial plan (IND) to the European Medicines Agency (EMA). ...
Nov 27, 2024
On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ)...
Nov 27, 2024
On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide) for the reduction of risk of non-fatal myocardial infarction in adults with established cardiovascular disease. Wegovy® was approved in Canada for the treatment of...
Nov 26, 2024
On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®) was accepted by the People’s Republic of China's National Medical Products Administration...
Nov 26, 2024
On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech's and Novartis' Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab biosimilar approved in Australia. Omylclo® was approved in Australia for two presentations: 75 mg/0.5...
Nov 26, 2024
On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India's Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India. The CDSCO granted approval for the use of Lynparza® in combination with...
Nov 25, 2024
On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) for the treatment of patients with...
Nov 22, 2024
On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for chronic idiopathic thrombocytopenic purpura (ITP) in children (IV...
Nov 22, 2024
On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative...
Nov 22, 2024
On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively. Stoboclo™ and Osenvelt™ are the first...
Nov 21, 2024
On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of...
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