On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing...
![Gedeon Richter’s EU Denosumab Biosimilars Accepted](https://www.pearceip.law/wp-content/uploads/2022/02/Placeholder.jpg.webp)
On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing...
On 18 July 2024, Boehringer Ingelheim (BI) and GoodRx announced that Boehringer's high and low concentration...
On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant...
In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports...
AVEO Oncology has revealed that its Phase 3 clinical trial (TiNivo-2) results demonstrate the addition of Opdivo®...
On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products...
On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for...
On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV...
On 17 July 2024, ASLAN Pharmaceuticals announced that it has filed for voluntary liquidation of its Singaporean sole...
On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and...
On 16 July 2024, Sandoz announced the Canadian launch of Wyost® (denosumab), biosimilar to Amgen’s Xgeva®. Wyost® is...
On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare...
On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong...
On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been...
On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report. The report, which has been published...
On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for...