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Novartis on Wednesday (February 1) predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Adjusted for overall negative currency effects, group sales in 2022 advanced 4 per cent to $50.5 billion as gains from heart failure drug Entresto and multiple sclerosis (MS) drug Kesimpta were partly offset by competition from cheap generic copies of established MS drug Gilenya. Novartis said it was on track to spin off its generics unit Sandoz in the second half of the year as part of its effort to sharpen its focus on its patented prescription medicines. Analysts have welcomed a programme unveiled in 2022 to trim costs and cut 8,000 jobs and plans to focus on fewer therapy areas and drug technologies. But the market has been underwhelmed by prospects for medium-term growth from new drugs.

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.

Department of Health of Social Care (DHSC) has confirmed that the Dexcom One Transmitter will be added to Part IXA of the March 2023 Drug Tariff. "Previously, patients were advised to obtain the free-of-charge Dexcom One transmitters directly from the pharmacies, without a prescription, as the original Drug Tariff application for the transmitter was unsuccessful," said the Pharmaceutical Services Negotiating Committee (PSNC) It has raised concerns with DHSC and Dexcom that these distribution arrangements for transmitters are unacceptable because they result in extra unfunded activity for community pharmacies. Both, DHSC and Dexcom acted upon these concerns by agreeing to add the Dexcom One transmitter to the Drug Tariff from March 2023. At the same time, Dexcom One CGM System (containing 1 sensor, 1 sensor applicator, 1 transmitter) will also be added to the March Drug Tariff.

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.

Kent and Medway prescribe the highest number of semaglutide, liraglutide and tirzepeptide - drugs that are commonly used for treating type 2 diabetes, weight loss, or both - in the UK, according to recent research by Click Pharmacy. Called GLP-1 agonists, these drugs mimic the effects of the GLP-1 hormone, which is released by the body after eating. This hormone slows digestion, stimulates insulin release, and inhibits glucagon, a hormone that raises blood sugar, making GLP-1 agonists effective treatments for diabetes and weight management. The online pharmacy's research reveals that Kent and Medway prescribed the most of these drugs in the month of June 2024, with 6,326 prescriptions. Other NHS Integrated Care Boards (ICBs) with high prescription rates included: Black Country and West Birmingham (5,019) Hampshire, Southampton, and Isle of Wight (4,960) Birmingham and Solihull (4,775) North Central London (4,528) North East London (3,557) North West London (3,498) Cambridgeshire and Peterborough (2,973) Coventry and Warwickshire (2,912) Norfolk and Waveny (2,575) Brighton and Hove topped the list for prescribing Wegovy, a weight-loss drug containing semaglutide, with 35 prescriptions made out in June alone.

A comprehensive cohort study has shed light on the benefits and risks associated with weight-loss drugs, offering valuable insights for clinical care and future research. Published in Nature Medicine on 20 January 2024, the study found the use of glucagon-like peptide 1 receptor agonists (GLP-1RAs)-used to treat diabetes and obesity-associated with a reduced risk of substance use disorders (including alcohol, cannabis, opioid and stimulant use disorders). Weight-loss drug use was also linked to decreased risks of psychotic disorders, seizures, neurocognitive disorders (including Alzheimer's disease and dementia), coagulation disorders, cardiometabolic disorders, infectious illnesses and several respiratory conditions. However, the use of GLP-1RAs was not without risks, as researchers identified an increased risk of gastrointestinal disorders, hypotension, syncope, arthritic conditions, nephrolithiasis, interstitial nephritis, and drug-induced pancreatitis associated with their use. The analysis, utilising the U.S. Department of Veterans Affairs databases, compared 215,970 GLP-1 RA users with patients using sulphonylureas (n=159,465), DPP4 inhibitors (n=117,989), SGLT2 inhibitors (n=258,614), or a composite of the three (n=536,068).

EHR technologies can help prevent medical errors by highlighting potential drug interactions and adverse reactions. Today, a number of features have been integrated into EHR systems which can prompt alerts for drug-food or drug-drug interactions. Moreover, it can check for allergies, and previous documentation of adverse reactions to a particular drug thus avoiding a medical error.

EHR technologies can help prevent medical errors by highlighting potential drug interactions and adverse reactions. Today, a number of features have been integrated into EHR systems which can prompt alerts for drug-food or drug-drug interactions. Moreover, it can check for allergies, and previous documentation of adverse reactions to a particular drug thus avoiding a medical error.

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."

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.