Regulatory Index News: 04/12/2017

Welcome to your Regulatory News digest this Monday. Take a few minutes to update yourself with what is going on in the Pharmaceutical industry today.

“Low-value treatments” no longer provided by NHS England

Savings are on the mind of NHS England, with recommendations that “low-value treatments” such as dietary supplements, herbal remedies and homeopathy will no longer be available on the NHS. Guidance will be issued to GP’s and clinical commission groups (CCGs) to remove some of these treatments which are considered ineffective, unsafe or of low clinical value and restrict the use of some others. This could save the NHS up to £141 million a year. Other NHS cost-cutting restrictions also seem imminent with a separate consultation to reduce prescriptions of some OTC products such as paracetamol, sun creams, laxatives and eye drops next year which could also save the NHS £190 million a year and free-up GP time. If you would like to read more on this from a PharmaTimes article, please click here.

Sanofi proposal to limit on use of own dengue vaccine

Sanofi plan to ask medicine regulators around the globe to limit the use of their Dengue vaccine, Dengvaxia, to people who have previously been infected with the mosquito-borne virus after long-term clinical data suggested differences in treatment efficacy depending on past infection history. A six-year clinical study found that those patients which had never been infected by dengue and were vaccinated could experience a severe case of the disease upon a subsequent infection. Whilst those which had previously been infected with the virus and then vaccinated, showed a persistent protective benefit. This is expected to make a net income dent of €100 million after tax for their fourth quarter and is a major setback for Sanofi’s hope for the vaccine. Please click here if you would like to read more from a BioPharmaDIVE article.

FDA approval for the first Herceptin biosimilar

Mylan and Biocon’s Ogivri has received the first ever Herceptin biosimilar US approval from the FDA for use in patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene. The approval is based on the evidence that Ogivri is biosimilar to the innovator Herceptin after extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data. Mylan and Biocon are now awaiting the review by Australian, Canadian, European and other regulatory authorities to expand on the now 19 countries with approval. If this story interests you, please click here to read further from a PharmaTimes article. 



Max Lymbery

Date Published

04th December 2017

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