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What Brexit means for drug regulation

The pharmaceutical sector is one of the most tightly regulated industries, and most of the rules that govern the daily lives of UK drug companies are enshrined in EU law. With the shape of the UK’s exit from the EU still unknown it is hard to predict what the future holds for medicine regulation.

Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for its drug to treat intestinal worm infestations. 

The company said the 500mg chewable mebendazole tablet will provide a treatment and prevention alternative for soil-transmitted helminthiasis (STH). 

Scottish regulators back BMS’ Opdivo for lung cancer

Bristol-Myers Squibb (NYSE: BMY) said the Scottish Medicines Consortium (SMC) has recommended cancer immunotherapy Opdivo (nivolumab) to treat advanced squamous non-small cell lung cancer (NSCLC). 

The drug is currently being assessed by National Institute for Health and Care Excellence (Nice). Opdivo also remains unavailable in Wales and Northern Ireland. 

Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis

The National Institute for Health and Care Excellence (Nice) has recommended UCB Pharma’s Cimzia (certolizumab pegol) on its own or in combination with methotrexate, to treat rheumatoid arthritis when other drugs haven’t worked or aren’t suitable.

The regulator already recommends Cimzia for treating severe rheumatoid arthritis which has not responded to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs).

AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor

Anglo-Swedish drug firm AstraZeneca (LSE: AZN) has filed a temporary restraining order to prevent the US Food and Drug Administration from approving generic versions of its biggest selling cholesterol drug Crestor (rosuvastatin) set for patent expiry.

The company said the regulator should hold off any approvals until a decision is made on its claim that the statin is protected by seven more years of exclusivity due to a paediatric indication.

US FDA approves Roche Cobas HPV Test

The US Food and Drug Administration (FDA) has approved cancer drugmaker Roche’s (VTX: ROG) cobas HPV Test.

The first test for Human Papilloma Virus or HPV that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.

The test is manufactured by Roche while SurePath Preservative Fluid is manufactured by US-based Becton Dickinson and Company.

The FDA approved HPV tests to be used with specific collection fluid, which store and preserve cervical cell samples for testing in the laboratory.

Nice rejects BMS’ immunotherapy Opdivo for previously treated kidney cancer on pricing

UK regulators have rejected Bristol-Myers Squibb’s (NYSE: BMY) immunotherapy Opdivo for previously treated kidney cancer on pricing and substantial uncertainty about the extent of the survival benefit of nivolumab when measured over the long term. 

US doctors received $6.5 billion from drug, device firms in 2015

Doctors and hospitals received nearly $6.5 billion in research and speaking fees as well as other goods or services from the pharma companies, biotech firms and medical-device makers in 2015, according to the Centers for Medicare & Medicaid Services (CMS) Open Payments report.

Overall the companies received about $3.9 billion in payments for research and $2.6 billion for other purposes.

UK healthcare professionals received £340.3 million in benefits from pharma industry in 2015 discloses ABPI

“We don’t want our neighbours to know what we earn,” said Mike Thompson, the chief executive of industry body Association of the British Pharmaceutical Industry (ABPI) at a media briefing in London, as he launched a new initiative that will put the details of payments received by healthcare professionals in the public domain.

The industry body has launched Disclosure UK – a database that is set to list the details of payments made to doctors, nurses and pharmacists, as well as other health professionals and healthcare organisations in the UK.

Shire says trial drug for ADHD shows positive results

UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results. 

Philip Vickers head of research and development, said: “Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder. We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.” 

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