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Sep 23, 2024
On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September...
Sep 23, 2024
On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the...
Sep 23, 2024
On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis. UCB reports that...
Sep 20, 2024
On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not...
Sep 20, 2024
On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable...
Sep 19, 2024
On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or...
Sep 19, 2024
At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication...
Sep 19, 2024
At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept). Both Sandoz’s Afqlir™ and...
Sep 19, 2024
On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg) to reflect reduced...
Sep 18, 2024
On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA). The approval was based on positive results from a Phase 3 trial (MANDARA) comparing the efficacy and...
Sep 18, 2024
On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy, for first-line treatment of adults with unresectable advanced or...
Sep 18, 2024
On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. Hercessi™ was...
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