Novo Nordisk could get major fine

The U.S. Food and Drug Administration has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, […]

Modus Therapeutics has announced that sevuparin for the treatment of SCD was granted rare pediatric disease designation by the US Food & Drug Administration (FDA). “We are very pleased with the FDA’s decision to grant a rare pediatric disease designation to sevuparin for SCD. The potential for Modus Therapeutics to be granted a Rare Disease Priority […]

AstraZeneca and Merck & Co (MSD) have announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic […]

The European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. Lokelma is a highly-selective, oral potassium-removing agent. The approval is supported by data from three double-blind, placebo-controlled […]

AstraZeneca announces that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D. The […]

The company has received a positive outcome from the NAD (National Advertising Division) regarding a challenge filed on Fungi-Nail, the largest US competitor to the Kerasal Nail product. NAD recommends the advertiser to discontinue current product packaging and commercials. Moberg Pharma expects the outcome to further strengthen Kerasal Nails position and growth prospects in the […]

The European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have […]