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says GlobalData

Cassava Sciences recently announced that the Food and Drug Administration (FDA) had denied a Citizen Petition and associated supplements filed by investors questioning the credibility of positive data from the company’s Phase IIb trial (NCT04079803) of late-stage Alzheimer’s disease (AD) asset, simufilam. Despite this win for the company, simufilam still has further hurdles to face in securing a solid position in the AD market, says GlobalData, a leading data and analytics company. Leia Mais »

Sanofi’s Dupixent could potentially change the treatment paradigm for eosinophilic esophagitis, says GlobalData

Sanofi submitted its Dupixent (dupilumab) data for eosinophilic esophagitis (EoE) to the Food and Drug Administration (FDA) on February 28, just a couple of weeks after the discontinuation of Takeda’s Eohilia (budesonide oral suspension) after it failed to gain an FDA approval. If successful, Dupixent will be the first to market for EoE and will offer challenging competition for other biologics trying to find a position in the market, says GlobalData, a leading data and analytics company.

The Phase III (NCT03633617) data showed that Dupixent significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo in adolescents and adults ages 12 years and older. Additionally, Sanofi announced its plan to file for approval in other countries later this year.

Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, comments: “The sale of high-priced Dupixent represents the most impactful driver of growth for the EoE market. GlobalData expects Dupixent to become the market leader with sales of $915.6 million in 2030.”

EoE is a chronic, immune-mediated, atopic, inflammatory condition of the esophagus that has gained recognition over the past two decades. In EoE, eosinophils infiltrate the esophagus, contributing to tissue damage and chronic inflammation. The current treatment options for EoE patients are off-label symptomatic treatments such as proton pump inhibitors (omeprazole and pantoprazole) and corticosteroids (budesonide and fluticasone propionate).

Emamzadeh continues: “Dupixent, an interleukin 4 receptor subunit alpha inhibitor, is injected subcutaneously once weekly. This is a lower frequency of administration than that of currently available off-label therapies. Although it is a first-in-class drug for EoE, Dupixent is a blockbuster drug for several allergic disorders including eczema, rhinosinusitis, asthma, and atopic dermatitis. Additionally, it is very well known among physicians.”

Dupixent is the only pipeline agent being studied in Phase III (NCT04394351) for a younger population, specifically ages 1–11. This study is expected to launch in Q2 2024. Other pipeline agents in Phase III are Ellodi’s APT-1011, which is expected to launch in Q1 2023 for adults ages 18 years and older and Q1 2024 for adolescents ages 12–17 years; biologics such as Bristol Myers Squibb’s cendakimab (RPC-4046), which is expected to launch in Q2 2024; and AstraZeneca’s Fasenra (benralizumab), which is expected to launch in Q4 2025 for adolescents and adult ages 12 years and older.

Emamzadeh adds: “Key opinion leaders interviewed by GlobalData expected Dupixent to target a small patient population that does not respond to current therapies for EoE. As a result, the launch of Dupixent is not very likely to reduce the use of off-label proton pump inhibitors and corticosteroids in the first and second line, respectively.”

Novartis’ Leqvio has potential to lead the cholesterol-lowering space due to its administration convenience, says GlobalData Leia Mais »

Despite launch of seven pipeline agents, bipolar disorder market will see only modest growth due to persistent generic erosion, says GlobalData Leia Mais »

Pianoro (Bologna) – Marchesini Group is opening the doors of its Beauty Division to show the world the latest technologies developed in the field of cosmetic product processing and packaging. From 26 to 30 April, the new 5,000 square metres facilities, recently built inside the Pianoro Headquarters, will host a large selection of machines and production lines developed to meet the needs of the cosmetic industry: from large multinationals to small laboratories, customers and suppliers will be offered an up-close look at technologies designed to cater for the entire production cycle of a cosmetic product, from process to end of line. Leia Mais »

The panel of speakers at upcoming gut health science digital learning event, ‘Frontiers in Gut Microbiome Research: Application in Nutrition, Health and Wellbeing’ has been revealed by co-hosts Clasado Biosciences (Clasado) and the Quadram Institute. Leia Mais »

AI together with Big Data will be the most disruptive emerging technology duo in the pharmaceutical sector in 2022, says GlobalData

Despite being years away from exhibiting its full potential, artificial intelligence (AI), together with Big Data, stand out as a versatile combination to address challenges faced by the entire pharmaceutical value chain, says GlobalData, a leading data and analytics company.

In GlobalData’s latest report, ‘The State of the Biopharmaceutical Industry – 2022’, AI, followed by Big Data, were rated by healthcare industry professionals as the top two emerging technologies to have the greatest impact on the pharmaceutical industry in 2022 (rating scale from 1 to 5, where 5 indicated the greatest impact, 1 – minimal impact). This is replicating the same trend seen in the 2021 edition of the report.

Urte Jakimaviciute, Senior Director of Market Research at GlobalData, comments: “AI and Big Data are linked in the healthcare industry. Data derived from numerous pharmaceutical processes can only add value if it is properly analyzed and therefore produces actionable results. As a data-driven algorithm, AI requires high-quality data. The more data AI ingests, the more accurate and efficient it can become. Competence in these tech areas is vital for healthcare companies, as they provide improved patient care at a micro level and, more broadly, drives a higher level of insights and trends that benefit operational and clinical efficiency.”

The growing number of successful AI use cases in the pharmaceutical industry is also contributing to the ever-growing trust in AI. Leading pharma companies forging partnerships in AI include AstraZeneca, GSK, Pfizer, Roche, Janssen, BMS, Merck, Novartis, Takeda, and Bayer.

Jakimaviciute continues: “AI has already shown it can deliver significant productivity improvements and drive efficiencies in drug development processes.”

In January 2020, Exscientia and Sumitomo Dainippon announced the first compound, DSP-1181, designed by AI, to enter a Phase I clinical trial for obsessive compulsive disorder. The project required less than 12 months to complete the exploratory research phase. The second molecule produced by this partnership, DSP-0038, for Alzheimer’s disease psychosis, entered clinical trials in May 2021. In April 2020, BenevolentAI identified Eli Lilly’s baricitinib as a potential COVID-19 treatment in just three days. In April 2021, Exscientia and Evotec announced a Phase I trial for the first AI-designed immuno-oncology drug.

Jakimaviciute adds: “AI in drug discovery has started receiving more and more attention since 2020, with an increasing number of AI-focused vendors, high-value financing rounds, and pharma partnerships. These trends will continue to gather pace and we should witness more of these collaborations in the future.

“Less than one month into 2022 and we have already seen Sanofi sealing a deal with Exscientia to develop oncology and immunology treatments. Further, BenevolentAI and AstraZeneca have agreed on an expansion of their AI-powered drug discovery partnership to include systemic lupus erythematosus and heart failure. This indicates that the role of AI in the drug discovery and development process is only set to grow.”

Drug pricing and reimbursement-related concerns will remain the leading impediment to the pharmaceutical industry’s growth in 2022, says GlobalData

Drug pricing pressures will continue to hinder the growth of the pharmaceutical industry in 2022, forcing companies to reassess their pricing strategies and market focus, says GlobalData, a leading data and analytics company. Leia Mais »

Thousands of patients could unknowingly suffer with a rare life-threatening disease, experts have warned. Leia Mais »

he partnership will allow Canada’s CRO to leverage cutting-edge technology provided

by the European HealthTech company, in order to innovate and optimize

preclinical studies

Canada/Europe, 3 February 2022 – Canadian CRO IonsGate Preclinical Services Inc (IonsGate), that is a market leader in preclinical research services, and European life sciences company InSilicoTrials just announced a partnership to leverage innovative technology like Modeling and Simulation. Leia Mais »