The European Commission has approved Bristol-Myers Squibb’s Opdivo in combination with low-dose Yervoy for first-line treatment for patients with intermediate and poor risk advanced renal cell carcinoma (RCC). BMS has stated that the approval marks the first of an immuno-oncology combination therapy for patients with this type of cancer in the European Union. Clearance is
BMS’s Opdivo is on track to add resected high-risk advanced melanoma to its current list of indications, after receiving a priority review from the US FDA. The regulatory agency has already granted Opdivo breakthrough therapy designation for this setting, marking its seventh such designation. Murdo Gordon, Chief Commercial Officer at BMS, said: “Priority review of
NICE publishes draft guidelines recommending that Bristol Myers-Squibb provide more data on Opdivo’s effectiveness for treating classical Hodgkin lymphoma. The committee said its current position is to not recommend the immunotherapy as an option for patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.
European Commission expanded approved indications for Bristol-Myers Squibb’s biologic Orencia, thereby allowing its use in patients with highly active and progressive rheumatoid arthritis that have not previously been treated with methotrexate. In the past the European regulator approved Orencia in combination with methotrexate in 2010 for adults who have moderate to severe active RA that
Opdivo, Bristol-Myers Squibb’s immunotherapy, can now be used to treat more patients with lung cancer and those with kidney cancer after EU regulators expanded the drug’s approved indications.
Scotland’s regulatory advisory committee, the Scottish Medicines Consortium (SMC) have granted approval to Bristol-Myers Squibb’s Daklinza and Yervoy for use on the NHS in Scotland. Specifically, Daklinza (daclatasvir) received regulatory approval for use with other drugs for the treatment of chronic hepatitis C virus infection in adults. The approval grants access to Daklinza as a
England and Wales’ cost regulator, NICE, have published draft guidance recommending that Bristol-Myers Squibb’s Yervoy (ipilimumab) should only be used by the National Health Service (NHS) for patients in clinical trials, as current evidence is lacking. The regulatory body has already approved the skin cancer drug as a second-line treatment for advanced malignant melanoma, but
Patients with diabetes in Scotland have gained routine access to AstraZeneca/ Bristol-Myers Squibb’s Forxiga on the UK National Health Service (NHS) after it was considered cost-effective by the Scottish Medicines Consortium (SMC). The SMC have dispensed guidance to healthcare professionals approving the use of the first-in-class drug Forxiga (dapagliflozin) in adults with type 2 diabetes
Bristol-Myers Squibb (B-MS) yesterday announced that they have completed their $5 billion purchase of Amylin and its diabetes franchise, meaning they can now progress onto a planned marketing alliance with drug giant AstraZeneca. The New York-based drug maker, who agreed to buy Amylin on the 1st July, confirmed that they have now successfully finalised their
A new indication for Bristol-Myers Squibb (BMS) and Eli Lilly’s Erbitux, which is sold outside the USA by Merck KGaA, has been approved by US regulators. Meanwhile, the US Food and Drug Administration (FDA) have also cleared the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit which was developed by the Netherlands-based firm,