Blog Archives | Page 60 of 101

Recent BioBlast® Updates

New Indication Alert: J&J’s Tremfya® (Guselkumab) FDA-Approved for UC

Sep 11, 2024

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC)....

Bio-Thera and Biogen Tocilizumab Phase 3 Switching Study

Sep 11, 2024

On 11 September 2024, Bio-Thera Solutions and Biogen published results from their phase 3 switching study for Tofidence™ (BAT1806/BIIB800), biosimilar to Roche’s Actemra®/RoActemra® (tocilizumab). The study showed that comparable clinical efficacy, safety,...

Approval Alert: Celltrion’s Biosimilar Ustekinumab Approved in AU

Sep 11, 2024

The Australian Therapeutic Goods Administration (TGA) has approved Celltrion’s SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab). SteQeyma is approved for a 130 mg/26 mL concentrate for solution for infusion vial to treat moderate to severe plaque...

Iconovo Commences Development of Intranasal Semaglutide

Sep 10, 2024

On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity. The product will reportedly use an improved form of Iconovo’s existing intranasal inhaler “ICOone Nasal®”....

Eli Lilly Reports Positive Phase 3 Results for Weekly Insulin Injections

Sep 10, 2024

On 10 September 2024, Eli Lilly announced that it met the primary endpoints for A1C (blood glucose measurement) reduction in the QWINT-2 (type 2 diabetes) and QWINT-5 (type 1 diabetes) trials for once weekly insulin efsitora alfa. The results were simultaneously...

Bayer’s High Dose Eylea™ (Aflibercept) PFS Approved in Europe

Sep 9, 2024

On 9 September 2024, Bayer announced that the European Medicines Agency (EMA) has approved its Eylea™ (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick™”, for nAMD and diabetic macular oedema (DME). Bayer reports that Germany will be one of the first launch...

BMS’ Opdivo® Funded for Kidney Cancer in NZ from 1 November 2024

Sep 9, 2024

New Zealand’s government drug funding agency Pharmac has announced that BMS’ Opdivo® (nivolumab) will be fully funded for eligible kidney patients from 1 November 2024. As previously reported, New Zealand has recently increased funding for cancer drugs, including...

UPC Denies Novartis/Genentech Preliminary Injunction Against Celltrion in Omalizumab Patent Dispute

Sep 6, 2024

On 6 September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of EP3805248 relating to an omalizumab formulation. The UPC proceedings (case Numbers:...

Novo Nordisk Presents 21 Abstracts at EU Diabetes Meeting, Including Results of IcoSema and Semaglutide Trials

Sep 6, 2024

On 6 September 2024, Novo Nordisk announced its presentation of 21 abstracts and other data at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) held from 9 to 13 September 2024. The data to be presented include results from the...

Celltrion Plans: 11 New Biosimilars Approved by 2025, Portfolio of 22 by 2030

Sep 6, 2024

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”. Celltrion has 8...

Evernorth to Supply Ustekinumab Biosimilar to Accredo Patients in US with No Out-of-Pocket Costs

Sep 5, 2024

On 5 September 2024, Cigna Group member, Evernorth, announced that it will offer biosimilar ustekinumab to US patients through its specialty pharmacy, Accredo, with no patient out-of-pocket costs. The biosimilar offering, available beginning in early 2025, will be...

Novo Nordisk Sues Sun Pharmaceutical and Mylan in US Over Generic Wegovy® (Semaglutide)

Sep 5, 2024

On 5 September 2024, Novo Nordisk filed separate lawsuits in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan asserting infringement of US patent number 12,029,779 (granted 9 July 2024), which claims a method of reducing...