Regulatory
Biovica Capital Markets Day invitation June 9
Biovica, active in cancer diagnostics, will host a virtual Capital Markets Day on Wednesday 9 June from 14.00 to 16.30.
Biovica’s DiviTumTKa shows strong capabilities in malignant melanoma
May 20, 2021 – Biovica, active in cancer diagnostics, today announces that DiviTumTKa shows prognostic and predictive capabilities in metastatic cutaneous melanoma patients undergoing immunotherapy. These results from a new study at Karolinska University Hospital will be presented at the upcoming ASCO annual meeting, June 4-8, 2021.
Biovica strengthens the management team
Biovica, active in cancer diagnostics, today announced that the company has strengthened the management team with Helle Fisker as new commercial manager and Joakim Arwidson as new quality and regulatory manager.
Q3 Interim report November-January 2020/2021
FDA resumes review of DiviTum®TKa submission
Biovica’s DiviTumTKa prognostic for long-term outcome
Biovica, active in cancer diagnostics, today announced that the results from the breast cancer study PROMIX at Karolinska University Hospital is published in the scientific journal ESMO Open. The study showed that testing for TKa levels during early treatment is prognostic for the long-term outcome of preoperative chemotherapy.
Nomination Committee for Biovica for the 2021 Annual General Meeting
The Nomination Committee prior to the 2021 Annual General Meeting will consist of three members, who shall represent the two shareholders with the most number of shares who accept the assignment to be part of the Nomination Committee as of December 31, 2020, and the Chairman of the Board. The Nomination Committee then appoints a chairman among its members.
FDA resumes review of DiviTum®TKa submission
Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa.
FDA resource reallocation continues to impact DiviTum®TKa timeline
Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.
Biovica Q2 Interim Report August-October 2020/2021
Convincing study results and application submitted to the FDA – commercialization just around the corner
Biovica’s FDA submission will proceed to substantive review
Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends.