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Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exc...

The US District Court of Delaware has set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024.  BMS filed a complaint against AstraZeneca in March 2022, alleging that AstraZeneca’s Imfinzi® (durvalumab) infrin...

Merck announced that it has received a positive opinion from the CHMP for its  anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection.  CHMP addition...

The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®.  The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used...

Biocon Biologics and Viatris announce the launch of Abevmy® (biosimilar bevacizumab) in Canada.  Abevmy® was jointly developed by Biocon Biologics and Viatris, and is indicated for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung c...

Korea Biomedical Review reported that Celltrion has submitted a global Ph III clinical trial plan for CT-P47 (biosimilar tocilizumab) to Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.  The global Ph III trial commenced in May ...

Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD.  Ongavia® will be Teva’s first biosimilar commercialised in Europe, and t...

Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea.  Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech.  The Kor...