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Novartis' Heart Drug Gets Accelerated Review in Britain for High-Risk Patients – Nasdaq

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Britain’s National Health Service (NHS) announced an agreement with pharmaceutical giant Novartis (NYSE: NVS) to help accelerate the review process for its heart drug inclisiran. The agreement would see inclisiran provided to patients who are at high risk of cardiovascular incidents (heart attacks and strokes) once a separate U.K.-based clinical trial yields its results.

The drug has already been submitted for approval from U.S. regulators back in 2019 and is currently pending approval. Inclisiran goes after a specific protein called PCSK9, which plays a role in producing LDL cholesterol (also known as the “bad” cholesterol) and is intended to be used alongside conventional cholesterol-lowering medications such as statins.

Image source: Getty Images.

Heart disease is the leading cause of death in the U.K., causing twice as many deaths in comparison to the second biggest killer, lung cancer. However, the overall number of deaths in the U.K. has fallen by almost 50% over the past decade, although national healthcare agencies are far from satisfied with leaving it at that.

What this means for Novartis

Novartis is expecting that future sales for its drug will shoot up significantly thanks to this deal. The company ended up buying the rights for inclisiran for $9.7 billion back in 2019 and expects the drug to be a major blockbuster in the years to come.

If inclisiran ends up winning approval from U.K. health regulators, the deal also stipulates that the NHS will subsidize the price of the drug and offer it as an add-on therapy for patients that don’t respond well to statins. While an official price wasn’t agreed upon, inclisiran is intended to be competitively priced alongside competitor drugs such as Sanofi’s Praluent and Amgen’s Repatha. 

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Remarkable New T-Cell Discovery Can Kill Several Cancer Types in The Lab – ScienceAlert

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The discovery of a new kind of immune cell receptor could pave the way for a new type of T-cell cancer therapy that can attack a diverse range of cancers in human patients without requiring tailored treatment.

The researchers behind the discovery emphasise that testing is still at an early stage, having been conducted only in mice and in human cells in the lab, not yet in living patients. But the preliminary results are promising, and suggest we could be on the verge of a significant advancement in T-cell therapies.

To understand why, let’s backtrack a little on what T-cells are, and what T-cell therapies do, because they’re still very much an emerging field of treatment in oncology.

T-cells are a type of white blood cell involved in the function of our immune system. When T-cells are activated by coming into contact with defective or foreign cells in the body, they attack them, helping us fight off infection and disease.

In T-cell therapy – the most common form of which is called CAR-T (for Chimeric Antigen Receptor T-cells), scientists hijack and augment this natural function of T-cells to steer them towards tumour cells in particular.

In CAR-T treatments, doctors extract T-cells from patients’ blood, genetically engineering them in the lab to make them specifically identify and target cancer cells. The edited T-cells are then multiplied in the lab before being administered to patients.

Some of the limitations of the CAR-T technique are that the edited T-cells are only able to recognise a few kinds of cancer, and the entire therapy needs to be personalised for different people because of a T-cell receptor (TCR) called human leukocyte antigen (HLA).

HLA is what enables T-cells to detect cancer cells, but it varies between individuals. And that’s where this new discovery comes in.

In the new study, led by scientists at Cardiff University in the UK, researchers used CRISPR–Cas9 screening to discover a new kind of TCR in T-cells: a receptor molecule called MR1.

MR1 functions similarly to HLA in terms of scanning and recognising cancer cells, but one big difference is that, unlike HLA, it doesn’t vary in the human population – which means it could potentially form the basis of a T-cell therapy that works for a much broader range of people (in theory, at least).

We’re not there yet; but preliminary experiments in the lab involving MR1 are indeed promising, although we need to be aware that the results need to be replicated safely in clinical trials before we can confirm this is a treatment suitable for humans.

In lab tests using human cells, the MR1-equipped T-cells “killed the multiple cancer cell lines tested (lung, melanoma, leukaemia, colon, breast, prostate, bone and ovarian) that did not share a common HLA,” the authors write in their paper.

Tests upon mice with leukaemia – in which the animals were injected with the MR1 cells – revealed evidence of cancer regression, and led to the mice living longer than controls.

Right now, we don’t yet know how many types of cancers a technique based on this receptor might treat. That said, the early results certainly suggest a diverse range could be susceptible, according to the study.

If these sorts of effects can be replicated in humans – something the scientists hope to begin testing as early as this year – we could be looking at a bright new future for T-cell treatments, experts say.

“This research represents a new way of targeting cancer cells that is really quite exciting, although much more research is needed to understand precisely how it works,” says research and policy director Alasdair Rankin from blood cancer charity Bloodwise, who was not involved in the research.

To that end, the next step for the team – in addition to organising future clinical trials – will be learning more about the mechanisms that enable MR1 to identify cancer cells at a molecular level.

There’s a lot more to learn here before we can truly proclaim this is some kind of universal cancer treatment, but there certainly look to be some exciting discoveries on the horizon.

“Cancer-targeting via MR1-restricted T-cells is an exciting new frontier,” says senior researcher and cancer immunotherapy specialist Andrew Sewell.

“It raises the prospect of .. a single type of T-cell that could be capable of destroying many different types of cancers across the population. Previously nobody believed this could be possible.”

The findings are reported in Nature Immunology.

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Health officials declare syphilis outbreak in Nova Scotia – The Globe and Mail

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Nova Scotia is declaring a provincial outbreak of syphilis after seeing a jump in the number of cases last year.

Public health officials said today there were 82 cases recorded in 2019, compared with 50 in 2018 and 38 in 2017.

Twenty per cent of the cases last year were women, up from 10 per cent the year before.

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The bacterial illness is a sexually transmitted infection and can be contracted through unprotected anal, oral or vaginal sex.

Dr. Gaynor Watson-Creed, the deputy medical officer, says safer sex practices and getting tested for syphilis can help control the numbers of infections.

The illness is treatable with antibiotics, but later stages of syphilis can cause serious impacts to the brain, heart and other organs, and can even lead to death.

The last syphilis outbreak in the province was declared in the Halifax area in 2009, hitting a peak in 2013 with 84 cases that year.

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Public health officials declare syphilis outbreak in Nova Scotia

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Public health officials have declared a provincial outbreak of syphilis after an increase in cases in 2019, according to a statement released by the Nova Scotia Health Authority (NSHA) on Monday.

Syphilis is a bacterial sexually transmitted infection (STI) contracted through unprotected anal, oral or vaginal sex. It can cause serious and permanent damage to the body if untreated.

According to the NSHA, preliminary data recorded 82 cases in Nova Scotia in 2019. That compares to approximately 50 cases in 2018 and 38 cases in 2017. The cases to date have been diagnosed in people ages 20 to 65 across the province.

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NSHA also stated there appeared to be an increasing proportion of cases among women (20 per cent) in 2019, compared to 10 per cent in 2018 and five per cent in 2017.

“Safer sex practices and getting tested for syphilis can help decrease the number of syphilis cases we are seeing in Nova Scotia currently,” Dr. Gaynor Watson-Creed, Nova Scotia’s deputy medical officer of health, said in a media release. “Knowing your status for sexually transmitted infections, including syphilis, is really important for our health and also the health of others.”

Symptoms of syphilis may first appear 10 to 90 days after a person becomes infected, with the average period of time being 21 days. While some people may not experience any symptoms, syphilis can produce different symptoms at each stage of infection, including:

  • an open sore at the point of infection (genital area, anus, mouth or lips)
  • flu-like illness
  • muscle aches and pains
  • fatigue
  • a rash on the chest, back, palms of hands and bottoms of feet

Syphilis is treatable with antibiotics. Later stages of syphilis can cause serious impact on the brain, heart and other organs, or even death.

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Safe sex practices, including the use of condoms and oral dams for each sexual interaction, can help prevent syphilis. Unprotected sexual contact increases the risk of contracting syphilis and other sexually transmitted infections.

In order to prevent congenital syphilis, which is an infection in unborn babies or newborns that can cause miscarriage, stillbirth or birth defects, NSHA said the province’s public health and reproductive care program recommends that doctors now test for syphilis twice during pregnancy.

“This second test, completed at 24 to 28 weeks, will complement the routine syphilis screening that takes place early in pregnancy,” NSHA stated.

To date, there have been no reported cases of congenital syphilis in Nova Scotia.

A syphilis outbreak was declared in the Halifax area in 2009, hitting a peak in 2013 with 84 cases that year. The Public Health Agency of Canada has put a syphilis outbreak investigation co-ordination committee in place to inform surveillance and outbreak control measures across the country, which may inform additional protection measures and recommendations.

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For now, Watson-Creed said, it’s most important that people know the signs and symptoms of syphilis, use protection for sexual activity and get tested for syphilis and other STIs if they are at risk.

“Being informed, taking action and protecting yourself are the best steps right now,” he said.

Nova Scotians can also call 811 for non-emergency health advice from a registered nurse.

© 2020 Global News, a division of Corus Entertainment Inc.

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