After first-round losses to Samoa and Belgium respectively, Brazil and Namibia must be at their very best in the reverse fixtures at The Sevens Stadium in Dubai on Thursday in their quest to become the final nation to qualify…
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Man from Iver who threatened air steward has sentence tripled
A man who threatened to rape and murder an air steward has had his prison sentence more than tripled.
In February 2023, Salman Iftikhar, 38, from Iver, near Gerrards Cross in Buckinghamshire, made the threats while intoxicated on a flight from London to Lahore, Pakistan.
In August at Isleworth Crown Court, he was sentenced to 15 months in prison for one count of making threats to kill and one count of racially aggravated intentional harassment.
His sentence has been increased to four years and three months following a referral by the law officers – who are senior legal advisors to the government – to the Court of Appeal under the unduly lenient sentence scheme.
His abuse had continued during the eight-hour flight and he told other cabin crew their hotels would be blown up.
The crew had discussed diverting the flight to Turkey, as the abuse was so serious.
In a statement, the woman who was the main target of Iftikhar’s abuse said she remained “haunted and traumatised” and had had to take 14 months off work.
Ellie Reeves MP, the solicitor general, said: “Salman Iftikhar made horrific threats of rape and violence against an air steward who was simply doing her job.
“His tirade of hate and abuse caused distress and anguish for the whole flight, and all of our thoughts today should be with the cabin crew and passengers who suffered from Iftikhar’s vile behaviour.”
Reeves added that his case went to the Court of Appeal after “several requests” from members of the public to review his sentence.
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UK to pioneer adaptable licensing for orphan medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) is exploring a move to a more flexible, iterative licensing regime for treatments targeted at rare diseases – broadly, medicinal products intended to treat conditions prevalent in no more than five in every 10,000 people, also known as orphan medicines – after identifying problems with the way existing regulatory requirements map to such treatments.
“Current regulatory pathways assume large populations, standard endpoints, and multiple trials,” the MHRA said. “Rare disease therapies, however, need flexibility, adaptable trial designs, real-world evidence, and expedited review – needs that existing frameworks do not adequately support.”
The MHRA’s plans for a more adaptable regulatory regime for orphan medicines are not yet fully fledged – it intends to publish a draft framework by spring 2026 – but its recent policy paper provides an insight into how the system might operate. At the heart of the plans is the intention to develop “a regulatory process which bridges clinical trials and marketing authorisations”.
In practice, this could mean the MHRA granting “preliminary approvals” based on “appropriate, albeit limited, evidence” with “iterative reassessment” thereafter. It might also involve substituting the need for some clinical trials by relying on other “real-world data” or “natural history comparators”.
The system could be underpinned by a pooling of data internationally via new “global rare disease registries”, so that developers would have a greater sample size to consider patients and outcomes. Other “appropriate post-market monitoring”, the MHRA said, might entail the need for further studies to be undertaken to “clarify and further define risks” if new evidence emerges once products have been brought to market.
The MHRA said it is seeking to ensure that the new regulatory regime for orphan medicines is aligned with the health technology assessment process, which in England is overseen by the National Institute for Health and Care Excellence (NICE). However, experts in medicines regulation at Pinsent Masons called on the MHRA to go further.
Catherine Drew of Pinsent Masons said: “This is a bold approach from the MHRA and is clearly targeted at making the UK an attractive place for the approval of therapies for rare diseases. One could imagine that on the proposed pathway the UK acts in effect as a ‘test bed’ environment, generating further data; prior to the therapy being rolled out globally. Such an approach has the potential to benefit UK patients – if this innovative approach is coupled with an innovative bespoke reward, be that regulatory or intellectual property, such as an additional supplementary protection certificate (SPC) term. There is also the potential of additional significant benefit to originators in engaging with the MHRA in this regime.”
“However, the regulatory pathway for orphan medicines is only part of the puzzle. The MHRA has not addressed the question of the NHS then paying for the products that are developed,” she said.
Gareth Morgan of Pinsent Masons added: “With orphan medicines, the market manufacturers are supplying to is often very small, meaning the price they need to charge healthcare providers like the NHS to obtain a fair return on their investment is typically significantly greater than the average medicinal product.”
“NICE has said that there is flexibility in the system – that they can spend three- to 10-times more than average on rare disease therapies – but many clients do not benefit from this. NICE also said its remit is to get the most ‘health per pound spent’ – an overarching metric that is at odds with the idea of investing in rare disease therapies. In our experience, many clients have struggled to get NICE on board due to the high level of statistical uncertainty around outcomes that low patient numbers bring to orphan drug studies. This level of uncertainty often bleeds into pricing negotiations as NICE will use outcome uncertainty against companies, for example, inferring lower efficacy – and, under its QALY metrics, apply a lower value to the product than manufacturers can reasonably accept,” he said.
“It is imperative that the MHRA seeks alignment of pricing issues with a revised regulatory pathway for orphan medicines if manufacturers are truly going to be incentivised to focus greater resources into the development of those treatments for the UK market,” Morgan said.
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Mooney ton powers Scorchers to first win
Mooney upped the ante again, getting a six off Jess Jonassen en route to a 42-ball fifty. Mack finally got a four but her outing ended when she was bowled by Jonassen. Mooney, meanwhile, continued scoring at a quick rate, including three fours…
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Historic shutdown is nearly over, leaving no winners and much frustration
WASHINGTON (AP) — The longest government shutdown in history could conclude as soon as Wednesday, Day 43, with almost no one happy with the final result.
Democrats didn’t get the heath insurance…
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Reason for bloating and gas not gluten, but ‘this’ ingredient in bread, says Lancet study
Have you ever felt bloated after consuming bread, and blamed it all on ‘gluten’? Well, it turns out gluten might not the actual culprit. Recent research published in The Lancet has redirected the blame away from gluten, and onto another…
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Threshold Effect of the Lymphocyte to HDL-C Ratio on the Risk of Strok
Introduction
Stroke-associated pneumonia (SAP) represents a major complication with high clinical impact following acute ischemic stroke (AIS).1 Its incidence varies substantially, with prevalence rates reported between 4% and 23% across…
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new tickets available every week
After a few days of suspension, Fondazione Milano Cortina 2026 is ready to reopen the Olympic ticket office, less than one hundred days from the Opening Ceremony of the Winter Games.
As of today, November 12, ticket sales windows open on the…
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Rashid Khan gets married again, second marriage within a year: Social media calls it, ‘Injustice to his first wife' – livemint.com
- Rashid Khan gets married again, second marriage within a year: Social media calls it, ‘Injustice to his first wife’ livemint.com
- “She Is My Wife”: Rashid Khan Stumps Cricket World, Confirms 2nd Marriage NDTV Sports
- Afghan Influencer BREAKS…
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new tickets available every week
After a few days of suspension, Fondazione Milano Cortina 2026 is ready to reopen the Olympic ticket office, less than one hundred days from the Opening Ceremony of the Winter Games.
As of today, November 12, ticket sales windows open on the…
Continue Reading
