Drug Development Pharma - August 28, 2019
FDA grants Fast Track designation for AstraZeneca’s Farxiga
The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines […]
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 […]
Agreement - June 4, 2019
Xbrane enters term-sheet with STADA
The company has entered a non-binding term-sheet with STADA Arzneimittel for cooperation regarding sales and marketing of Spherotide for Europe, and furthermore, the company updates on its plans to take the product into a phase III study in endometriosis patients. Non-binding term-sheet with STADA The company´s non-binding term-sheet with STADA consists of an agreement to […]
Drug Development Pharma - April 23, 2019
Vicore Pharma announces second indication for VP01
The company has selected diffuse systemic sclerosis (dSSc) as the second indication for its lead program VP01 (C21), which complements the primary indication, idiopathic pulmonary fibrosis (IPF). Diffuse systemic sclerosis is a disease with a strong involvement of angiotensin II and an upregulation of the angiotensin II type 2 receptor (AT2R – the C21 target), […]
Drug Development Pharma - February 11, 2019
Follicum selects new drug candidate
The biotech company reports that a novel peptide drug candidate for the treatment of diabetes and protection of beta cells has been selected. The drug candidate has shown effects in both in vitro and in vivo-models, including diabetes-related complications. The drug will now be tested in a preclinical program prior to upcoming clinical trials. The choice of drug […]
Drug Development Pharma - June 12, 2018
Nordic Nanovector has been granted Fast Track designation
The US Food & Drug Administration has granted Fast Track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies. “This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the […]
