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On 25 July 2024, Kashiv BioSciences announced completion of patient enrolment in a Phase III trial of ADL018, its biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).  The study aims to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immu...

On 25 July 2024, Sandoz announced the European launch of Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab) for treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis.  Although Pyzchiva® is not the first approved ustekinu...

On 25 July 2024, Bio-Thera announced commencement of an integrated Phase I/III trial for its BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in non-squamous, non-small cell lung cancer (nsNSCLC).  The study will compare the pharmacokinetics, efficacy and safety of B...

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent (dupilumab) grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024. 

Earlier this month, Dupixent® received Eur...

On 25 July 2024, AstraZeneca announced the FDA’s Oncologic Drugs Advisory Committee acknowledged that its Imfinzi® (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC), based on Phase III result...

On 25 July 2024, Galderma announced that results from its Phase III trials on nemolizumab, published in The Lancet, demonstrate statistically and clinically significant improvements in inflammation and itch in moderate to severe atopic dermatitis.  The studies evaluated the...

On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted.  BAT2206 is the first biosimilar to Janssen’s Stelara® (ustekinumab) developed by a Chinese company to be submitted to the FDA or EMA for approval.  

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On 24 July 2024, Merus announced that the first patient has been dosed in its Phase 3 trial evaluating the efficacy and safety of petosemtamab, compared with single agent chemotherapy or cetuximab in previously treated patients with recurrent/metastatic head and neck squamo...

On 23 July 2024, the Patent Trial and Appeal Board (PTAB) issued judgment against Regeneron in relation to the inter partes review (IPR2023-00884) commenced by Samsung Bioepis, Celltrion (IPR2024-00260) and Biocon (IPR2024-00298) challenging the validity of all claims of Re...

On 23 July 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for semaglutide (Wegovy®) to reduce the risk of serious heart problems or strokes in overweight and obese adults.  Already approved for obesity and weight management, s...