Pharmaceuticals, Biotechnology and Life Sciences
CannEpil+ , based on CannEpil, designed by MGC Pharma to treat Refractory Epilepsy, has been approved for import into the UK by the Medicines and Healthcare products Regulatory Agency via its UK distribution and clinical access partner Elite Pharmaco.
Novartis got an acceptance by the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in people who had received prior systemic therapy.
MGC Pharmaceuticals, a specialist in phytocannabinoid-derived medicines, has signed a binding US Market Supply and Distribution Agreement with US-based AMC Holdings, with minimum orders of $24 million for MGC products including CannEpil®, CogniCann® and CimetrA™ over the initial 3 year period.
BB Biotech, a Swiss investment company in the field of biotechnology, said Friday its shares returned 5.8% in CHF and 6.1% in EUR in the second quarter of 2021
Through a new distribution agreement, Lonza will supply a selection of cells to be prequalified for use in CN Bio’s innovative PhysioMimixTM Organ-On-a-Chip (OOC) range of Single- and Multi-Organ Microphysiological Systems (MPS)
The European Medicines Agency (EMA) has validated and accepted Chinese HUTCHMED Limited’s marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has reached almost unanimous vote that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent (DD) adult patients.
ImmuPharma, the specialist drug discovery and development company, has appointed Dr Tim Franklin, Chief Operating Officer, to the Board of Directors.
LEO Pharma UK said that the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) has approved tralokinumab for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
On Tuesday, Novartis disclosed new data showing mean IgG and IgM levels remain unchanged in adults with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab) over 3.5 years.