The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates.
It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for
drug development.
The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies.
Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory
success, safeguarding the massive investments of pharma companies."
"Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the
new PharmaPendium to solve this," he added.
Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants,
immunosuppressants and drugs to treat type 2 diabetes and ADHD.
Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply
problems, the highest on record in the UK, and more than double the number recorded at the start of 2022.
More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK.
The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but
Brexit is also cited as another reason for the problem.
Atorvastatin was the most dispensed drug in England in 2021/22 with 53.4 million items, revealed the annual Prescription Cost Analysis (PCA) published by
NHS Business Services Authority.
According to the official statistics, Apixaban (an anticoagulant) was the drug with the highest cost of £401 million.
The statistics revealed that the cost of prescription items dispensed in the community in England was £9.69 billion, a 0.87 per cent increase of £83.7 million
from £9.61 billion in 2020/21.
"The number of prescription items dispensed in the community in England was 1.14 billion, a 2.58 per cent increase of 28.7 million items from 1.11 billion in
2020/21."
FreeStyle Libre 2 Sensor kit (a glucose monitoring system) was the presentation with the largest absolute increase in cost between 2020/21 and 2021/22 of £69.8
million, from £2.84 million to £72.6 million.
Anglo-Swedish drugmaker AstraZeneca said on Monday (January 9) that it had struck a deal to buy US-based drug developer CinCor Pharma for up to $1.8 billion
to increase its stock of heart and kidney drugs.
Core to the deal is CinCor's experimental therapy baxdrostat, which is in development to treat conditions including high blood pressure and chronic kidney disease.
AstraZeneca aims to combine baxdrostat with its own Farxiga, a diabetes drug whose sales ballooned after it was also shown to benefit patients with heart failure
and kidney disease.
Farxiga, whose sales jumped by almost 50 per cent during the first nine months of 2022 to reach $3.2 billion, belongs to a highly competitive class of drugs that
includes rivals such as Boehringer Ingelheim and Eli Lilly's Jardiance.
AstraZeneca gets about a third of its revenue from cancer drugs, but its heart, kidney and diabetes medicines are its second most lucrative business by sales,
generating roughly $6.9 billion of the drugmaker's total revenue of more than $33 billion in the first three quarters of 2022.
Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully
administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four
drug candidates intended for use as licensed pain medications.
The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome.
The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single
ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to
confirm its value as a potential drug.
Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.
Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed
with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year.
It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S.
government's Medicare plan for people age 65 and over, potential side effects and cost.
One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000
per year.
"Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a
massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer.
Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced
the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain
swelling and brain bleeding.
There has been extensive national media coverage today (August 11) on how medicine shortages have forced patients to visit multiple pharmacies to get their
prescriptions filled or return to their GP to be prescribed alternative drugs.
These media reports have been based on a survey involving more than 1,500 pharmacists in the UK, in which over a half of those polled said that their patients'
health had been put at risk in the last six months.
In response to a query from Pharmacy Business, the Department of Health and Social Care (DHSC) said it monitors the medicines supply chain closely to prevent any
shortages and acts swiftly when any issue arises.
A DHSC spokesperson told Pharmacy Business: "We take patient safety extremely seriously and we routinely share information about medicine supply issues directly
with the NHS so they can put plans in place to reduce the risk of any shortage impacting patients, including offering alternative medication.
An oral drug combination by Novartis showed promise in treating a subgroup of patients suffering from a common childhood brain cancer in a trial.
In the mid-stage trial, 47 per cent of the patients that were given the two drugs Tafinlar and Mekinist saw their tumours shrink, far above a rate of 11 per cent
in a comparative group of participants on standard chemotherapy, the drugmaker said on Monday, June 6.
The participants, aged one to 17 years, were suffering from low-grade gliomas (LGG), the most common childhood brain cancer.
The trial only included those who were found to have a mutation known as BRAF V600, a genetic contributor in about 15 per cent to 20 per cent of paediatric LGG cases.
Among further results of the trial with 110 participants, the median time without disease progression was 20.1 months for those given the Novartis drug combo,
compared to 7.4 months on chemotherapy.
The new oral treatment candidate also caused less severe side effects than burdensome chemotherapy.
The NHS has signed the first-of-its-kind subscription deal for two antimicrobial drugs - cefiderocol and ceftazidime-avibactam, manufactured by Shionogi and Pfizer respectively - that will help around 1700 patients per year with severe bacterial infections.
Under this deal, pharmaceutical firms will receive a fixed yearly fee - capped at a level that represents value to taxpayers - in order to incentivise funding for innovation that can generate a pipeline of new antibiotics for NHS patients.
NHS said the deal will help patients with serious infections that have evolved so much that antibiotics and other current treatments are no longer effective can be
given a potentially life-saving alternative. The drugs will provide a lifeline to patients with life-threatening infections like sepsis, hospital or ventilator pneumonia and blood stream infection.
Announcing the deal at NHS ConfedExpo, NHS Chief Executive Amanda Pritchard called the revolutionary subscription deal a game-changer and the latest NHS success in using its commercial power to benefit NHS patients in line with the NHS Long Term Plan.
"Superbug-busting drugs on the NHS will save lives and strike a blow in the global battle against antimicrobial resistance," Pritchard said.
When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the
popular antibiotic.
But a few extra shifts was as far as he could go.
Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he
was paid more for the generic drug to cover sharply rising costs.
But, like many other European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first
launched in the country two decades ago, and it has barely budged since.
"It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre.
"We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."
Department of Health and Social Care (DHSC) has increased the rate of discount deduction for generics from 17.52 per cent to 20 per cent.
The Drug Tariff for April 2023 will contain changes to the discount deduction arrangements for pharmacy contractors, which will include- all concession lines to be
considered as Group Items for Discount Not Deducted i.e. DND or zero discount (ZD) items; and rate of discount deduction for generics to increase from 17.52% to 20%
The Pharmaceutical Services Negotiating Committee (PSNC) and DHSC agreed on the changes for all concession lines to be considered as Group Items for Discount Not
Deducted. Therefore from 1 April 2023, a new category will be introduced into Part II of the Drug Tariff 'Drugs for which discount is not deducted'.
However, the committee had rejected the changes in the rate of discount deduction for generics. It said, "Following pressure from NHS England, Ministers have now
chosen to impose changes to the previously agreed discount deduction arrangements, which come into effect from 1 April, and will be kept under review."
Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7).
Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics.
The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc.
Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December."
Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.
Aspen has committed not to charge more for its six generic cancer drugs for the next 10 years in the UK, according to the Competition and Markets Authority (CMA).
The CMA also clarified that "although these commitments were offered while the UK was a part of the European Union" they remain "legally binding".
It added: "The CMA has now assisted the NHS to secure binding undertakings from Aspen, under the law of England and Wales, which enshrine the UK elements of the
commitments and are enforceable by UK courts, including in relation to the supply of these drugs in Northern Ireland and Scotland."
This allows NHS to monitor and ensure compliance by Aspen following the UK's exit from the EU.
In 2017, the European Commission began an investigation into Aspen over concerns that the company had engaged in excessive pricing for 6 off-patent cancer medicines.
The NHS has launched plans to expand pioneering subscription-style drug contracts to develop lifesaving antibiotics of the future.
It is building on its world-first pilot to incentivise the pharmaceutical industry to develop new antibiotics that could be offered to NHS patients when they
need them the most.
The consultation has launched almost a year to the day that contracts for two superbug-busting drugs were rolled out as part of a world-first pilot.
Cefiderocol and ceftazidime-avibactam, new antibiotics manufactured by Shionogi and Pfizer respectively, were awarded world-first subscription contracts which
provided the companies with a fixed annual fee based primarily on the availability of the drugs and their value to the NHS, as opposed to the volumes used.
By breaking the link between the payments companies receive and the number of their antibiotics prescribed, the NHS is removing any incentive to overuse antibiotics,
decreasing the risk of life-threatening infections, such as sepsis and pneumonia, becoming resistant to treatment.
Amgen's experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year,
company officials said ahead of a data presentation on Saturday (December 3).
The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as
AMG133.
Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight
loss of 14.5%.
At 150 days after the last dose, maintained weight loss had dropped to 11.2% below original weight at the start of the trial, according to findings detailed at a
meeting of World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles.
Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose,
Amgen said.
The regulators have added 10 new products to the 'Drugs for which Discount is Not Deducted' (DND) list from Thursday (01 June).
Community Pharmacy England on behalf of its members had made further applications to the Department of Health and Social Care (DHSC) and the NHS Business Services
Authority (NHSBSA), resulting in the inclusion of 10 new products in the DND.
More than 610 products are granted DND status following checks made by Community Pharmacy England's dispensing & supply team over the past 3 years to ensure fair
reimbursement for our members.
The DND list is updated monthly by the DHSC and includes grouped and individual items. Individual items are separately listed in Part II of the Drug Tariff. Any
items covered by the 'Group Items' heading are not listed again individually in Part II.
"We will continue our work to assess whether other drugs and appliances fulfil the current DND entry requirements under either the 'Group' and 'Individual item'
criteria and make applications to NHSBSA and DHSC, on behalf of our members accordingly," said Community Pharmacy England.
Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some
of the most difficult-to-treat brain disorders, including Alzheimer's disease.
Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in
Alzheimer's disease, including a protein called amyloid and inflammation, researchers say.
The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating
diseases like Alzheimer's and Parkinson's.
Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases.
Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and
by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease.
Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.
The Taskforce report recognises the important role of community pharmacy and pharmacy teams, and in particular, the fact that they often have most contact with
individuals who are receiving medication assisted treatment, commented the Royal Pharmaceutical Society (RPS) on the publication of the Scottish Drug Deaths
Taskforce's final report.
The final report published on Thursday (June 21) follows four years of work developing and implementing a programme of actions to tackle the rising number of drug
deaths in Scotland.
RPS, as pharmacy's professional leadership body in Scotland and the rest of Great Britain, has positively engaged with the Taskforce as it carried out its work.
Last year, RPS published 'Pharmacy's role in reducing harm and preventing drugs deaths (Scotland)' which contained 14 key recommendations. Many of the recommended actions within the Taskforce's report align with RPS policy.
Dr Bharat Shah CBE regrets that neither community pharmacists nor pharmaceutical wholesalers in the UK have any control over how Category M reimbursement prices in Part VIII A of the Drug Tariff are determined.
The co-founder and chief executive of Sigma Pharmaceuticals was speaking at a conference organised by Avicenna in West London on Sunday (March 6).
Introduced into the Drug Tariff in April 2005, Category M is used to set the reimbursement prices of over 500 drugs.
The Department of Health and Social Care makes the final decision on the amount of reimbursement (cost of drugs and appliances supplied against an NHS prescription
form) and remuneration (fees paid as part of the NHS community pharmacy contract for the provision of a service).