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Nordic Nanovector has provided an update on PARADIGME, its Phase 2b trial of Betalutin in 3rd-line relapsed and anti-CD20 refractory follicular lymphoma. Following a comprehensive review and independent data evaluation of PARADIGME and a subsequent request for regulatory agency interaction, the Board of Directors has taken the difficult decision to discontinue the study, states the […]

Anders Findsen likes to be part of the different R&D aspects of an up-and-coming dynamic biotech company. As Research Scientist at NMD Pharma he gets to follow a compound from the beginning to hopefully going into the clinic in the end. NMD Pharma is a small private biotech company with approximately 30 employees, located in […]

CardiNor has signed an exclusive agreement with IBL-America for sales of the CardiNor Secretoneurin ELISA test in the US. By initially targeting research institutes, clinical research organisations and pharmaceutical companies, CardiNor aims to spread awareness of this biomarker and pave the way for future commercialisation upon US regulatory clearance, it states. “We are delighted to […]

Pila Pharma has announced that the preclinical toxicological three-month studies of the active substance XEN-D0501 has begun. Pila Pharma is, as previously announced, preparing a clinical phase 2b study of the drug candidate XEN-D0501 for type 2 diabetes. Previously, XEN-D0501 has been evaluated in both toxicological safety studies and in phase 1 and 2a clinical […]

The wait was over! After two long years during which numerous trade fairs could only take place virtually – or even had to be canceled – due to COVID-19, Shimadzu’s trade fair calendar is now completely full again. A big highlight on that calendar was analytica 2022 in Munich, one of the largest leading trade […]

Genmab has announced its intent to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022. The BLA submission is supported by results from the large […]

Ultimovacs has announced the completed recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs’ Phase II clinical trial of its universal cancer vaccine UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer […]

Patent, pricing, production, and partnerships – these are the four Ps that companies must keep front and center for a successful market entry. Orexo’s CEO Nikolaj Sørensen answers some questions about how his company addressed these aspects when Orexo entered the US market. Although Orexo has successfully entered into the US market, you have been […]

Bio-Me has employed Dr. Anne-Grethe Reichelt as International Sales and BD Manager. This step is part of the company’s plan to widen commercial adoption of their existing product portfolio as well as launching new products under development, it states. Anne-Grethe will report to Chief Business Officer Runar Vige. “This is a milestone hire for Bio-Me: […]

Scandinavian Biopharma has expanded the partnership with Emergent Travel Health Inc. to also include the marketing and distribution of Emergent’s oral typhoid vaccine (Ty21a) in Germany. Emergents oral typhoid vaccine will complement and strengthen Scandinavian Biopharma’s commercial portfolio by leveraging its existing marketing and distribution network in Germany, it states. Due to the travel restrictions […]