FDA approves Merck’s new antibacterial drug applications

The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible

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NICE partners with EMIG

NICE and EMIG are working together to increase understanding of the services the Institute offers the life sciences industry. The collaboration also aims to open up a new channel for the industry to give feedback to NICE to inform any review, monitoring or refinement of its processes. The partnership will run as a pilot scheme

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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The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost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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