Pharma Business - May 4, 2022
FDA accepts Orion’s sNDA and grants Priority Review
Orion’s collaboration partner Bayer has announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The application is being conducted under the FDA Oncology […]
COVID-19 - January 7, 2021
CureVac and Bayer join forces on COVID-19 vaccine candidate
Bayer has signed a collaboration and services agreement with CureVac, a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA). Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. To this end, Bayer will contribute […]
Drug Development Pharma - August 1, 2019
FDA approves Orion’s and Bayer’s darolutamide
The approval of darolutamide is based on the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Darolutamide Darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa. The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate […]
Uncategorized - May 14, 2019
Bayer’s new office at Karolinska Institutet is inaugurated
The inauguration was celebrated with a half-day event in Aula Medica focusing on science and collaboration. “Both Bayer and Karolinska Institutet welcomes collaboration between academia, healthcare and society – it is necessary to collaborate to meet global challenges – we are all in this together,” said Miriam Holstein, CEO of Bayer Nordics when she started […]
Collaboration - March 20, 2019
Pilloxa in strategic partnership with Bayer
Swedish Pilloxa is initiating a collaboration with the Scandinavian branch of Bayer and get the opportunity to introduce more people to their smart pillbox through Bayer’s network, both in Scandinavia and globally. “We see great potential in this innovation. For someone not too familiar in the subject it might seem like a trivial task to take […]
Pharma Business - March 8, 2019
Orion submitts Darolutamide for European marketing authorization
Orion Corporation and Bayer have announced that a marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Regulatory submission is based on positive data from Phase III study . ARAMIS trial The submission to the EMA is based on […]
