Novartis UK Ltd.

Novartis was found in breach of Clause 2 of the ABPI's Code of conduct for drug marketing in the U.K. Novartis has been consistently pushing the boundaries in digital pharma for years. However, the company has now encountered the intricate challenges associated with navigating regulatory guidelines. This has become evident as the Big Pharma has been hit with the U.K.'s most serious drug marketing breach. This latest case surrounds a podcast show called “Heart to Heart,” which was developed specifically for heart failure specialist nurses (HFSN). In one of the episodes, Novartis presented a series of efficacy claims and, even more significantly, safety claims. These assertions caught the attention of the PMCPA, the organization responsible for overseeing drug marketing regulations in the U.K. The claims that drew the PMCPA's concern involved the assertion that Entresto could potentially lead to an increase in energy levels. Notably, this claim was tied to the act of dressing and the energy expended during this activity. The PMCPA deemed the claim "misleading as it was incapable of substantiation."   The most serious claim for the PMCPA was Novartis’ reference on the podcast to a “slight but acceptable drop in renal function” with Entresto, a safety claim. The self-regulatory body said the claim came “without any qualification” and “downplayed the importance of renal function.” Because this claim was deemed misleading by the PMCPA and evolved around matters of safety, the PMCPA determined that Novartis "reduced confidence in, and brought discredit upon, the industry." This verdict amounted to a breach of the gravest nature, falling under Clause 2 of the ABPI Code, the most significant breach possible. The case concerning the podcast was initiated by an anonymous complainant who identified themselves as a cardiac specialist health professional. In a statement to Fierce Pharma Marketing Novartis U.K. said: “Novartis UK have received notice from the self-regulating body, the PMCPA, regarding a number of findings. We strongly regret the breaches and  have reviewed our internal processes. We remain committed to being a responsible partner for patients and the healthcare system.” This breach for Novartis is the second in as many months for Entresto as it comes after the PMCPA also wrapped the Big Pharma for not fully showing the drug’s safety risks on the therapy’s website.

Novartis has joined Cancer Research UK as the second major pharmaceutical company to partner in the charity’s determining extended therapeutic indications for existing drugs in rare molecularly-defined indications using a national evaluation (DETERMINE) trial. The trial was launched in November this year and enrolled paediatric and adult patients diagnosed with any rare cancer type with its focus on evaluating the multi-drug, precision medicine for rare cancers. The study was launched by Cancer Research UK’s Centre for Drug Development, the University of Manchester and Roche. With Novartis on board, Roche will continue providing access to cancer treatments via the study, supported by sponsorship and management from the Centre for Drug Development and trial leadership from the University of Manchester. The DETERMINE trial is focused on discovering whether existing drugs – including those which are licensed for more common types of cancer – could also benefit patients diagnosed with rare cancer types that the drug is not currently licensed for. Eligible patients will have taken part in genetic screening and will have had one of the particular genetic mutations detected in their cancer that can be targeted by a drug on the trial. Cancer Research UK has encouraged other pharmaceutical or biotechnology companies with targeted oncology agents which have been licensed or are close to being licensed, with the trial offering a chance to assess their agent in rare indications not included in their licence. With more companies involved, further access will be opened up to even more patients with rare cancers, offering them a chance of finding a potentially beneficial treatment. Any treatment that appears to be benefitting patients on the trial will be submitted for review by the Cancer Drugs Fund (CDF). It is then down to a decision made by the CDF, working in tandem with NHS England Clinical Policy team, as to whether a period of data collection in the CDF is appropriate in order to assess if the drug could be used as a routine treatment option on the NHS for patients with this cancer type. The Christie NHS Foundation Trust has been the first site to host the trial, with other sites soon to follow. This includes the Royal Marsden NHS Foundation Trust, the University of Glasgow and the University of Birmingham, as well as facilities across the entire adult and paediatric Experimental Cancer Medicine Centres network. Dr Gerrit Zijlstra, chief medical officer, Novartis UK, said: “At Novartis we are committed to reimagining medicine, and we are delighted to partner with Cancer Research UK and the University of Manchester to explore further potential of our innovative treatments in changing outcomes for adults, teenagers and children with rare cancers.”

NOVARTIS BIOME UK ANNOUNCES SELECTION FOR HEALTHHUB 21 Novartis UK has announced the selected companies for the Novartis BIOME UK HealthHub 21 Challenge, in collaboration with KQ Labs, the data driven health accelerator of the Francis Crick Institute, and LifeArc, the charity helping to turn science into benefits for patients. The four selected companies are Living With, Macusoft, Mendelian and NeutroCheck. These startups and small and medium enterprises (SMEs) will be supported as part of the BIOME UK HealthHub 21 cohort to develop and scale their concepts to digitise patient pathways and advance remote care, helping to address the challenges of the NHS at this time. Chinmay Bhatt, managing director of Novartis UK, Ireland & Nordics and Country President UK, said: “At Novartis UK, we are dedicated to supporting the NHS in building back better from the pandemic, especially through the uptake of digital solutions to improve service delivery, research outputs and the overall patient experience. “This year’s selected BIOME UK HealthHub companies are developing solutions with the potential to drive real change for the healthcare system and for patients. I am looking forward to joining them on their journeys and seeing the measurable benefits they will bring to the NHS and patients over the coming months and years”. TADA MEDICAL RAISES €5.8M IN GRANTS Tada Medical, a medtech company based in Sweden and accelerated in Lille Northern France, has won the SME Grand Slam and has become one of only two SMEs that have managed to get the three grants from EU in just one year, as part of the EIC Accelerator, EIC Fast Track to Innovation and Eurostars-2. Tada Medical is developing the ReLink medical device, a breakaway connector for an IV tube, designed to lessen complications and costs linked to accidental dislodgements which are proven challenges in both hospitals and home care. The company also benefits from a dedicated support provided by Eurasanté Bio-Acceleration programme, to maximise its chances of success on the French healthcare market. PAINCHEK FOR SCOTLAND'S VETERANS Scotland's provider for veterans, Erskine, has integrated the use of the AI-powered pain assessment tool, PainChek, to enable staff caring for residents to identify and document pain for every resident. Erskine has adopted the technology for residents within the charity’s four care homes - totalling 339 registered beds, including residents living with dementia or significant cognitive impairment. The PainChek app is available for use on mobile devices and uses AI to analyse micro-facial expressions indicative of pain. Derek Barron, director of Care at Erskine, said: “The introduction of the PainChek app supports us to provide excellent care to residents by identifying those who may be in pain. “This is especially important for people living with dementia who may not be able to verbalise that they are in pain and become distressed due to this. Using PainChek also supports Erskine’s digital strategy and mission to lead by collaborative example in delivering outstanding, person-centred care." FORKS OVER KNIVES DOCTORS JOIN LIFESUM'S HEALTH ADVISORY BOARD Swedish-based global nutrition app, Lifesum, has announced that managing directors, Alona Pulde and Matthew Lederman, have joined its Health Advisory Board with the ambition of reversing disease using nutrition and lifestyle medicine. Known for their appearance in the Forks Over Knives documentary and their book, The Forks Over Knives Plan, Dr Pulde is a family practitioner and Dr Lederman is a board-certified Internal Medicine physician. Drs Pulde and Lederman join existing Lifesum Health Advisory Board members Christina Meyer-Jax, MS, RDN, LDN and RYT and Andrew Zimmermann, founder of Behavior Design Collective. The Health Advisory Board’s combined expertise will aim to improve Lifesum's existing services and provide personalised nutritional recommendations and support them through their health journey. OMRON LAUNCHES PRODUCT FOR AFIB DETECTION AT HOME Health monitoring and therapy company, OMRON Healthcare, has launched OMRON Complete, its first single-lead electrocardiogram (ECG) and blood pressure (BP) monitor for home use. The device is designed for the detection of atrial fibrillation (AFib) and incorporates clinically validated ECG technology that can be used simultaneously with the usual BP check, which could potentially decrease consultation time and unnecessary appointments. “It’s all about building a more complete picture of cardiovascular health,” said André van Gils, global senior general manager at OMRON Healthcare. “In providing practitioners with far more comprehensive data sets for chronic diseases such as AFib and hypertension, managing and preventing serious incidents becomes a lot more achievable. Technology like this has the power to save lives while enabling practitioners to deliver more personalised care and represents a concrete step forward in our zero cardiovascular events vision.” APPLICATIONS OPEN FOR NHSX DIGITAL HEALTH PARTNERSHIP AWARD NHSX's Digital Health Partnership Award applications have opened for NHS organisations that want to scale their digital health technologies. The application bids opened on 1 July 2021 and invites applicants with technologies that enable those with long-term conditions to monitor their health at home or in the community. Applicants must ensure that they adhere to the Digital Technology Assessment Criteria and must also be able to show evidence of the success and shared learning opportunities to come from the technologies. There are three categories of funding available: up to £100,000, £250,000 and £500,000. More information on how to apply can be found here.