Pharma Business - February 7, 2023
AstraZeneca’s Forxiga approved in the EU
Forxiga has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF). “This broader indication for Forxiga for the treatment of symptomatic […]
Biotech Business - February 7, 2023
TILT Biotherapeutics closes 22 million EUR financing round
The financing was led by Finland’s Lifeline Ventures, an early-stage venture capital firm founded by serial entrepreneurs. This follows on from the first close of 10 million EUR in June 2022. This final close of 12 million EUR includes 5.9 million EUR equity from the European Innovation Council (EIC) Fund as well as a 2.1 […]
Pharma Business - February 1, 2023
Orion announces positive CHMP opinion
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is already approved under the […]
Pharma Business - February 1, 2023
Lundbeck announces FDA acceptance and priority review
Lundbeck and Otsuka Pharmaceutical have announced that the FDA has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. The FDA has assigned the application priority review and a Prescription Drug User Fee Act […]
Biotech Business - January 30, 2023
AdjuTec Pharma attracts public funding to optimize manufacturing
Just before Christmas, the Norwegian company announced that it has received support from Oslo County of 1.950 million NOK. The funding will support optimization of the synthesis of our two lead compounds, APC148 and APC247. The program will define the optimal characteristics of the substances that will be used for microbiology testing as well as […]
Biotech Business - January 20, 2023
Evaxion receives FDA fast-track designation
The U.S. Food and Drug Administration has granted the designation for the company’s personalized cancer therapy, EVX-01, in combination with KEYTRUDA. In December 2022, Evaxion received FDA approval to proceed with its Phase 2b clinical trial, where EVX-01 is given in combination with KEYTRUDA to patients with metastatic melanoma. On January 17, 2023, Evaxion furthermore […]
