Blog Archives | Page 61 of 101

Recent BioBlast® Updates

Outlook Therapeutics Completes Patient Enrolment for Ophthalmic Bevacizumab Trials

Sep 4, 2024

On 4 September 2024, Outlook Therapeutics announced that it has completed patient enrolment in its NORSE EIGHT clinical trial assessing the effectiveness of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for use in wet AMD. The trial is the final step...

MSD and EyeBio Announce Phase 2b/3 Clinical Trial of Restoret™ (MK-3000) for Diabetic Macular Oedema

Sep 4, 2024

On 4 September 2024, Merck (MSD) and EyeBio announced the initiation of the phase 2b/3 BRUNELLO trial (NCT06571045) evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular oedema (DME). Restoret™ is a tri-specific antibody that acts as an...

EC and UK’s MHRA Approve Celltrion’s Ustekinumab Biosimilar

Sep 4, 2024

In the last 2 weeks, Celltrion has received marketing approvals in the European Union and the United Kingdom for its ustekinumab, SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara®. On 26 August 2024, Celltrion announced that the European Commission has approved its...

MSD’s Keytruda® Plus Pfizer/Astellas’ Padcev® Approved in EU for Urothelial Carcinoma

Sep 3, 2024

On 3 September 2024, MSD announced that Keytruda® (pembrolizumab) plus Pfizer/Astellas antibody drug conjugate Padcev® (enfortumab vedotin-ejfv) was approved by the European Commission (EC) for the first line treatment of unresectable or metastatic urothelial...

Sandoz Set For 2026 Generic Semaglutide Launch in Canada

Sep 3, 2024

On 3 September 2024, Bloomberg reported that Sandoz is planning a 2026 biosimilar semaglutide launch in Canada, reportedly after Novo Nordisk’s patent protection expires. Sandoz launches in the US and Europe are not planned until the early 2030s. This comes after...

Shanghai Henlius’ Biosimilar Pembrolizumab Clinical Trial Approved in China

Sep 2, 2024

On 2 September 2024, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an investigational new drug application (IND) for a clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab). Henlius...

Pfizer’s Biosimilar Adalimumab PBS-Listed in Australia

Sep 1, 2024

On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes. This comes three years after Abrilada was first...

PD-(L)1 Inhibitors on the Agenda for PBAC’s September Intracycle Meeting

Sep 1, 2024

On 1 September 2024, the PBS published its agenda for the September PBAC Intracycle Meeting, which will include an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to...

Approval Alert: UCB’s Bimzelx® (Bimekizumab) Receives Korean Approval for Moderate to Severe Plaque Psoriasis

Aug 30, 2024

On 30 August 2024, Korea Biomedical Review reported that UCB’s Bimzelx® (bimekizumab) has received approval from the Korean Ministry of Food and Drug Safety as a treatment for moderate to severe adult plaque psoriasis. UCB says that Bimzelx® is the only treatment for...

Alexion & Samsung Bioepis Settle Eculizumab US Patent Proceedings

Aug 30, 2024

On 30 August 2024, Alexion and Samsung Bioepis settled their US proceedings commenced in January 2024 regarding patents covering eculizumab. The parties filed voluntary dismissals in proceedings in the US District Court for the District of Delaware and the Court of...

Novo Nordisk’s Semaglutide Improves Mortality

Aug 30, 2024

On 30 August 2024, an article published in the American Journal of Cardiology reported the results of an analysis of data from the SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial in relation to the effects of...

Mabpharm’s Secukinumab Biosimilar Comparable to Novartis’ Cosentyx®

Aug 29, 2024

On 29 August 2024, Drug Design, Development and Therapy published the results of a Mabpharm-sponsored phase 1 study regarding CMAB015, biosimilar to Novartis’ Cosentyx® (secukinumab). The study demonstrated that Mabpharm’s CMAB015 showed equivalent pharmacokinetics...