FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

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FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

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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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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The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost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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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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Regulatory Professionals to attend TOPRA 2018 Symposium in Sweden

Regulatory Professionals employees Sarah Goddard, Divisional Director and Kirsty Calow, Divisional Manager will be exhibiting at the 2018 TOPRA Symposium, which is taking place in Sweden October 1-3rd. The Symposium features the following: Information on the latest regulatory developments Insight provided directly from Regulatory experts Opportunity for delegates to expand on their existing knowledge of

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