Regulatory Index News w/c 11 February 2019

Here is a selection of this week's news from around the world


SAW receives £1.5M funding for point-of-care diagnostics technology

SAW Diagnostics has announced that Innovate UK has awarded the company a £1.5 million grant in support of its low-cost sample preparation system, for use in infectious disease detection and other applications.

To read more follow this PharmaTimes link 


Teva predicts bleak year ahead as generic, Copaxone sales drop

Falling generic drug sales in North America and abroad have stung the Israeli drugmaker, as has the effects of copycat competition to its top-selling multiple sclerosis drug Copaxone. CEO Kåre Schultz, who was appointed in late 2017 to fix Teva's woes, has led a sweeping cost-cutting effort that's trimmed more than 10,000 jobs and reduced the company's expenses by more than $2 billion in 2018.

To read more follow this BioPharmaDive link


Novartis secures regulatory 'fast pass' in US OK for tropical disease drug

Swiss pharma Novartis has won the first Food and Drug Administration approval for a treatment for fascioliasis, an infectious disease caused by parasitic flatworms that's also known as liver fluke infestation.

To read more follow this BioPharmaDive link


First patient dosed in ADCT-402 Phase I trial for lymphoma

ADC Therapeutics has announced that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour activity of ADCT-402 (loncastuximab tesirine), in combination with AstraZeneca's Imfinzi (durvalumab), in patients with advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

To read more follow this PharmaTimes link


Althea to launch cannabis based products in the UK

Althea, the Australian medicinal cannabis company, has launched in the UK, following changes allowing specialist doctors to prescribe cannabis-based products for medicinal use (CBPM) to certain patients.

To read more follow this PharmaTimes link 


J&J's esketamine wins backing of key advisory panel

An advisory panel of experts on Tuesday recommended the Food and Drug Administration approve Johnson & Johnson's experimental depression drug esketamine, lending support for the agency to clear the treatment despite a mixed record in clinical testing. 

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

14th February 2019

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