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Jul 30, 2024
On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly...
Jul 30, 2024
Five days after Bio-Thera announced the start of its integrated Phase I/III trials for BAT3306 (pembrolizumab), on 30 July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®. The...
Jul 29, 2024
A United States federal grand jury has indicted a person from India for allegedly selling counterfeit cancer drugs and shipping them to Houston. The counterfeits are reported to include fake versions of MSD’s Keytruda®, Pfizer’s Adcetris® and Bristol Myers Squibb’s...
Jul 29, 2024
On 29 July 2024, Roche Canada announced that Health Canada has approved Vabysmo® (faricimab) injection for macular edema secondary to retinal vein occlusion (RVO). This is the third indication for Vabysmo® in Canada, following approvals for AMD and DME. Vabysmo® has...
Jul 29, 2024
On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan (marketed by Daiichi Sankyo/AstraZeneca as Enhertu®) for treatment of HER2-low breast cancer patients after...
Jul 26, 2024
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...
Jul 26, 2024
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...
Jul 26, 2024
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...
Jul 26, 2024
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...
Jul 26, 2024
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...
Jul 26, 2024
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...
Jul 25, 2024
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,...
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