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On 26 July 2024, Korean Ministry of Food and Drug Safety announced the approval of a prefilled syringe formulation of Amgen’s Xgeva® (denosumab).  International guidelines recommend Xgeva® for patients with bone metastases from various cancers, and its introduction as a pre...

On 26 July 2024, the US FDA issued an alert to healthcare providers in relation to dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®.  The FDA has received reports of adverse events, including hospit...

Novo Nordisk A/S announced on 26 July 2024 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a “positive opinion” for an update to the label of Wegovy® (semaglutide 2.4 mg) to reflect a risk reduction of major adverse c...

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.   

Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina ...

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Coherus/TMC Pharma’s Loqtorzi® (toripalimab) for nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.  The CHMP also r...

On 26 July 2024, AbbVie announced European Commission approval of Skyrizi® (risankizumab) for moderate to severe ulcerative colitis (UC).  Skyrizi® was already approved in the EU for plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease.   

The...

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...