Genmab and Pfizer have announced that the FDA has approved the supplemental Biologics License Application for TIVDAK for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval. TIVDAK is the first antibody-drug […]
Medivir’s selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD). The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years […]
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of efanesoctocog alfa, for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. Efanesoctocog alfa is a once-weekly and high-sustained factor VIII replacement therapy for patients of all ages and any […]
Moving its lab and U.S. headquarters to Research Triangle Park supports the strategy Immunovia announced in July 2023 to streamline operations and reduce costs. The move to Research Triangle Park follows Immunovia’s model development study and completion of the discovery phase for its next-generation test in November 2023. Following these developments, the company will focus […]
About half of the 26 employees were made redundant prior to the bankruptcy and the other half have had their employment agreements terminated following the bankruptcy. As things stand, most of the members of the leadership team are available for a short period of time to ensure compliance with applicable regulatory requirements and to assist […]
The company has announced the successful closure of an oversubscribed bridge financing round. Funding was provided by existing investors, such as Northern Venture CapSek, and new shareholders. The money will be used to support ongoing regulatory efforts and development of the company’s AI-driven support tool, Dermalyser, a clinically validated decision support tool for the diagnosis […]
Recently, the annual Entrepreneur’s Gala took place at Uppsala Castle to honor companies that showed exceptional performance during the past year and the Entrepreneur of the Year award was awarded to Ulrika Hammarström, CEO and Founder of Scandinavian CRO (SCRO). This prize is awarded by jury to an entrepreneur who has performed above and beyond […]
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