19 July 2024 | EU | Gedeon Richter’s EU Denosumab Biosimilars AcceptedOn 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing autho...
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By Naomi Pearce, Chantal Savage, Nathan Kan | Jul 22, 2024
19 July 2024 | EU | Gedeon Richter’s EU Denosumab Biosimilars AcceptedOn 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing autho...
By Bioblast Editor | Jul 19, 2024
On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for all indications of Regeneron’s Xgeva® and Prolia®. Gedeon Richter’s denosumab biosimilars are the fi...
By Chris Vindurampulle, Helen Macpherson | Jul 18, 2024
Apple Inc. [2024] APO 25 (25 June 2024)
Amazentis SA [2024] APO 27 (28 June 2024)
Date of decision: 25 and 28 June 2024, respectively
Body: APO<...
By Bioblast Editor | Jul 18, 2024
On 18 July 2024, Boehringer Ingelheim (BI) and GoodRx announced that Boehringer’s high and low concentration citrate-free Adalimumab-adbm products are being supplied in the US at a 92% discount from Humira® list price through GoodRx.
This follows the news in Ap...
By Bioblast Editor | Jul 18, 2024
On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).
This follows t...
By Bioblast Editor | Jul 18, 2024
In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports that its Vabysmo® (faricimab) was well-tolerated in DME patients receiving treatment for up to 4 years. The “RHONE-X” study met all primary endpoints, wit...
By Bioblast Editor | Jul 18, 2024
AVEO Oncology has revealed that its Phase 3 clinical trial (TiNivo-2) results demonstrate the addition of Opdivo® (nivolumab) to low dose Fotivda® (tivozanib) after prior immune checkpoint inhibitor (ICI) treatment is not superior to standard dose tivozanib alone, with the ...
By Bioblast Editor | Jul 17, 2024
On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept). The BA9101 application is for all Eylea® indications, nam...
By Bioblast Editor | Jul 17, 2024
On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic...
By Bioblast Editor | Jul 17, 2024
On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV product), a biosimilar to Janssen’s Remicade® (infliximab), has recorded European market share of over 20% for the first time since its 2020 EU launch. Th...
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