EC endorses BMS’s Opdivo for advanced renal cell carcinoma

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

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Scottish Medicines Consortium approves four medicines for NHS use

Roche’s early stage breast cancer treatment, Pertuzumab, hasbeen accepted by the Scottish Medicines Consortium (SMC) for use on the NHS in Scotland. The drug is used in combination with Trastuzumab and chemotherapy to treat a particular type of early stage breast cancer before surgery, and was accepted after consideration through SMC’s Patient and Clinician Engagement

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NICE approves UCB’s treatment for Psoriasis but disapproved Almirall’s

The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost effective. Certolizumab pegol has been previously approved in Europe in the new indication of plaque psoriasis, thereby adding to a list of uses including rheumatoid arthritis,

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CHMP recommend Shire’s rare disease treatment for use in EU

EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal

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NHS approves combination skin cancer therapy from Novartis

NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to

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Novartis seeks approval for Multiple Sclerosis drug in EU and US

Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on

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