Biotech Business - August 4, 2022
Biovica receives FDA approval
The FDA has granted 510(k) clearance for the product DiviTumTKa as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients. “We are excited to have received the formal approval from FDA for our DiviTumTKa assay, which is the first FDA cleared biomarker in this field. This […]
Biotech Business - July 13, 2022
BioInvent raises 300 million SEK
The Board of Directors of BioInvent International has resolved to issue 6,496,788 new shares in a directed share issue to international and Swedish institutional investors based on the authorization granted by the Annual General Meeting on April 28, 2022. “The performed directed share issue provides us with an even stronger base of institutional investors and […]
Agreement - July 1, 2022
Scandinavian Biopharma enters marketing and distribution agreement
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 […]
Biotech Business - June 27, 2022
Oncopeptides announces positive CHMP opinion
The company announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), has unanimously adopted a positive opinion recommending a full marketing authorization approval (MAA) of Pepaxti in EU. The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by […]
Prio - June 23, 2022
Immunicum announces corporate rebranding and name change
Immunicum announces corporate rebranding and name change to Mendus AB. The rebranding reflects an advancing pipeline in next generation cancer immunotherapies, upcoming manufacturing expansion, and long-term corporate aspirations, states the company. “The name Mendus captures our continued commitment to develop therapies that delay or reduce cases of cancer recurrence, while preserving the quality of life […]
Biotech Business - June 20, 2022
Elypta raises 21 million USD
Elypta has announced the raise of 21 million USD in a series A financing round led by Bonnier Ventures. “The series A is a pivotal moment for Elypta as it fully funds the development of our two leading indications,” says Karl Bergman, CEO at Elypta. “We believe it has great potential to improve cancer outcomes” […]
