Pharmaceuticals, Biotechnology and Life Sciences
The Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Novartis’s Cosentyx (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.
Novartis and Merck have both surprised experts in the past week by finding new ways to tackle heart disease, although the jury remains out as to whether this scientific success will translate into blockbuster sales.
Novartis ahs won European clerance for Erelzi, as the European Commission approved it for Novartis’s division Sandoz.
Novartis was cleared on Thursday by the US Food and Drug Administration (FDA) for combination of Tafinlar (dabrafenib) with Mekinist (trametinib) for treating metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express the BRAF V600E mutation, which is fourth actionable genomic biomaker in metastatic NSCLC
Novartis’s Phase III Cantos study of ACZ885 (canakinumab), one of the largest in the company’s history, combined with standard of care in people with a prior heart attack and inflammatory atherosclerosis has met the primary endpoint.
The world’s Ophtamology leader Novartis has reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER, with RTH258 3 mg, evaluated in HAWK, also met these endpoints.
European Commission (EC) has approved Sandoz’s Rixathon (biosimilar rituximab) for use in all indications of the reference medicine, MabThera.
Bristol-Myers Squibb and Novartis have entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen in combination with Mekinist (trametinib), as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).
European Commission (EC) has approved the inclusion of Treatment-free Remission (TFR) data in the Novartis’s Tasigna (nilotinib) Summary of Product Characteristics (SmPC).
Novartis has updated findings from the Phase III MONALEESA-2 study that reinforce the efficacy and safety of Kisqali (ribociclib) plus letrozole in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.