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According to GlobalData’s recent report , a total of five marketed messenger RNA (mRNA) non-vaccine products by 2028 will generate over $2 billion, generated by the approval of pipeline agents. billion during 2028. Challenges facing mRNA therapeutics.
This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria. If successful in other jurisdictions, such product will eventually make their way to Europe for approval.
In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. How will you ensure that vendors are complying with the requirements?
In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.
Unlike previous years where five to seven trends were examined, the 2025 report narrowed its focus to three that matter most and will make the most impact across the pharma landscape this year: applied AI, the Direct-to-Patient (DTP) model, as well as globalization and health equity. But the extent to which brands still have U.S.
The digital health market is being driven by expansion of digital connectivity, declining cost of sensors and other technology components, and an increase in patient engagement, and is predicted to reach a value of $450 billion by 2028, according to the company.
Enhertu has already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma, with annual sales for these indications alone expected to exceed $1.3bn by 2028.
Richter’s transformation (RT) is a rare blood cancer arising in up to 10% of patients with chronic lymphocytic leukemia (CLL) and presenting as aggressive lymphoma, typically as diffuse large B-cell lymphoma (DLBCL). Among the enrolled patients, 68 were previously treated and seven were newly diagnosed. The mOS was 13.1
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.
When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. Softgel capsules, containing a liquid, paste or emulsion active ingredient, are trusted and favoured by many patients. billion by 2028, at a CAGR of 12.6%.
GnRH antagonists have an improved safety and efficacy profile compared to the marketed GnRH agonists, which have significant side effects that are unappealing to patients. This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively.
These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition.
GlobalData’s analyst consensus forecast database estimates peak annual sales for ARV-110 of $325 million in 2028. All patients had received CDK4/6 inhibitors, and 79% had received AstraZeneca’s ER non-PROTAC degrader Faslodex (fulvestrant). Among 44 patients with measurable disease, two had confirmed partial responses.
The dearth of cancer drugs (only blood cancer drug Imbruvica made this first list) stems from CMS only pursuing negotiations for Part D drugs in 2026 and 2027, then expanding to Part B drugs in 2028. The biggest impacts are likely to be felt by patients with PDPs that use coinsurance, which most plans do for specialty drugs.
In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products. of the MDR and Article 110.4
The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. billion and $812 million in 2028. The company expects to hold regulatory talks to shape its incoming Phase III program in adult patients in the second half of 2023.
CAGR between 2020 and 2028. Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. FCM provides the data to help researchers identify potential biomarkers to better understand why certain patients develop resistance to a therapy. The importance of validation.
In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients.
They are designed to be safe and comfortable for patients, and typically have minimal side effects. According to various market research reports, the global non-invasive medical devices market was valued at approximately USD 45 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of over 6% from 2021 to 2028.
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.
Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patientsafety: “introducing mRNA carries the risk of activating the immune system.”
With the goal of supplying cell therapies, vaccines and other essential medicines such as antibody drugs to patients, the facilities aim to address major supply challenges and navigate the intricacies of producing fragile biological products. Subject to planning permission, the site is expected to be opened by 2028.
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