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Jun 28, 2024
On 28 June 2024, Zydus and Dr Reddy’s announced that they have entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India. Dr Reddy’s receives semi-exclusive rights under the agreement, while Zydus will receive upfront and subsequent milestone...
Jun 28, 2024
Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab). The studies demonstrated that HLX15 has similar pharmacokinetic characteristics, as well as comparable safety and...
Jun 28, 2024
Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion. If approved, faricimab will be...
Jun 28, 2024
On 28 June 2024, Formcyon and Klinge Biopharma GmbH announced that FDA has approved FYB203, biosimilar to Regeneron’s Eylea® (aflibercept) for nAMD, Diabetic Macular Edema, Diabetic Retinopathy and Macular Edema following Retinal Vein Occlusion. Klinge, which holds...
Jun 28, 2024
On 28 June 2024, AbbVie announced its acquisition of Celsius Therapeutics, a privately owned biotech firm developing treatments for patients suffering from inflammatory diseases. This includes CEL383, an anti-TREM1 antibody which has successfully completed a Phase 1...
Jun 27, 2024
On 27 June 2024, Korea Biomedical Review reported that Samsung Bioepis intends to launch its ustekinumab biosimilar Epyztek™ in Korea in July 2024. The product will be supplied at a 40% discount to J&J’s Stelara® (ustekinumab). Celltrion’s Steqeyma (CT-P43),...
Jun 27, 2024
On 27 June 2024, Coherus BioSciences announced that it has agreed to divest its Yusimry™, biosimilar to AbbVie’s Humira (adalimumab), to Hong Kong King-Friend (HKF) for up-front all-cash consideration of USD $40M. On the same day, Meitheal Pharmaceuticals, wholly...
Jun 27, 2024
At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab). The recommendation is for moderately to severely active Crohn’s disease,...
Jun 27, 2024
On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission...
Jun 26, 2024
Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity. The approval comes as the company plans a $4.1 billion expansion of its US...
Jun 26, 2024
On 25 June 2024, Simcere Zaiming announced the approval of Enlituo® (cetuximab beta) in the PRC for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). The drug was developed in...
Jun 26, 2024
On 26 June 2024, AbbVie announced that its Epkinly® (epcoritamab) received FDA approval for the treatment of adults with relapsed or refractory follicular lymphoma. This approval makes Epkinly® the first and only subcutaneous bispecific antibody approved in the US to...
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