The company could get a fine of several millions for crimes against Russia’s competition law, reports Life Science Sweden.
Russian competition authorities have found that Novo Nordisk could have breached the country’s competition law. The reason is reported to be a number of clauses in the company’s contract that limits competition. The purpose with the clauses is to meet international rules against corruption.
AstraZeneca has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). “The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a 1st-line standard of care…
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)…
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…
Mundipharma and Orexo have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv (buprenorphine and naloxone) sublingual tablet to the European Medicines Agency (EMA), seeking approval for the treatment of opioid dependence. If approval is received, the buprenorphine and naloxone sublingual tablet would be…
