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Mar 28, 2024
On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg...
Mar 28, 2024
Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated...
Mar 28, 2024
Merck (MSD) announced that the European Commission approved Keytruda® (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer...
Mar 27, 2024
On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar...
Mar 27, 2024
On 27 March 2024, Biocon announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) approved its liraglutide in the UK, which is the first approved biosimilar to Novo Nordisk’s Victoza® (liraglutide). Biocon’s liraglutide, a drug-device combination...
Mar 26, 2024
On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH). FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which...
Mar 25, 2024
The Korea Biomedical Review reports that South Korean company, Sam Chun Dang Pharm Co Ltd (SCD), has entered an exclusive distribution agreement with an unnamed distributor to supply its Eylea® (aflibercept) biosimilar in the UK, Belgium, the Netherlands, Norway,...
Mar 25, 2024
On 25 Mar 2024, Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for (up to) € 1.025B comprised of an initial payment and milestone payments. Cardior Pharmaceuticals specialises in RNA-targeted therapies aimed at preventing, repairing, and reversing...
Mar 24, 2024
On 24 March 2024, the Korea Economic Daily (KED) reported Samsung Bioepis entered pre-clinical stage, with multiple undisclosed gene therapy candidates, for the treatment of rare diseases. According to KED, Samsung Bioepis is committed to advancing drug development...
Mar 22, 2024
On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of two Janssen patents regarding the use of ustekinumab for the treatment of...
Mar 22, 2024
On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults. Once-weekly Awiqli®...
Mar 22, 2024
On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting. CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars: Sandoz’s denosumab...
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