11/26/2025  |  Jornal Cidades  RS

https://www.jornaldocomercio.com/jornal-cidades/2025/11/1227253-ufpel-participa-da-aprovacao-da-vacina-brasileira-contra-dengue.html 

The Federal University of Pelotas (UFPel), through the Clinical Research Center of the Teaching Hospital (HE-UFPel), participated in the study that led to the approval by the Brazilian Health Regulatory Agency (Anvisa) of the Brazilian dengue vaccine developed by the Butantan Institute. The approval is a historic milestone for science and public health in the country.
The vaccine is the first in the world capable of offering protection with just one dose, which translates into greater adherence by the population, simpler campaigns to organize, faster vaccination coverage in health emergencies, and a reduction in outpatient visits, hospitalizations, and deaths related to dengue. The vaccine is expected to be incorporated into the National Immunization Program (PNI).

Although the vaccine protocol began about a decade ago, UFPel was incorporated into the last stage of the research in 2022, participating in the Batch Consistency study, a fundamental regulatory requirement for the vaccine to be approved. In the stage conducted, 335 volunteers were randomized. The data collected at the institution were analyzed for consistency between batches, safety, and efficacy of the product. Participants who received a placebo during the study were subsequently vaccinated, as provided for in the protocol.

The vaccine was studied in people aged 12 to 59. In February 2026, UFPel will begin a new phase, in partnership with the Butantan Institute, to evaluate the vaccine in elderly people over 60, considering that mortality is higher in this age group and that there is still no vaccine approved worldwide for this group. The research at UFPel was coordinated by professor and researcher Danise Senna Oliveira, principal investigator at the university's Hospital School Research Center.

11/26/2025  |  Estado de Minas

https://www.em.com.br/saude/2025/11/7300522-anvisa-autoriza-pesquisa-clinica-da-fiocruz-para-tratamento-de-doenca-rara.html 

Pioneering development in Brazil is intended for children with type 1 spinal muscular atrophy (SMA), the most severe form of the disease

Anvisa has authorized the start of clinical trials with an advanced therapy product, a type of gene therapy, developed by the US company Gemma Biotherapeutics, Inc. (GEMMABio), in partnership with the Oswaldo Cruz Foundation (Fiocruz).

The product uses therapeutic gene delivery technology through viral vectors and, if its efficacy and safety are demonstrated in the development stages, it may in the future be used in the treatment of type 1 spinal muscular atrophy (SMA), the most severe form of the disease.

Fiocruz is directly involved in the clinical development of the product and has signed a technology transfer agreement, through the Institute of Immunobiological Technology (Bio-Manguinhos), so that, if registered, the drug can be produced in Brazil after its registration with Anvisa, contributing to national autonomy in the field of gene therapies. 

The authorized clinical study is phase 1/2 (initial phase), meaning that the focus is on evaluating safety and tolerability (phase 1) and the first signs of efficacy (phase 2). In this phase, the research will be conducted at least in three clinical centers in the country, including the Hospital de Clínicas de Porto Alegre (HCPA) and the Hospital das Clínicas da Universidade Estadual de Campinas (Unicamp). 

After completion of the clinical development phases, with due demonstration of safety, efficacy, and quality, the Agency may be asked to register the drug.

Anvisa has been conducting continuous regulatory monitoring with Fiocruz and GEMMABio, represented by the company Intrials Pesquisa Clínica Ltda., in order to ensure that all stages of regulatory evaluation proceed with technical rigor, safety, and agility.

The initiative is part of the government's effort to strengthen the Health Economic-Industrial Complex (Ceis) and boost domestic production of advanced therapies, which have been developed especially for the treatment of serious diseases that often have no available therapeutic alternative.

SMA
Spinal muscular atrophy (SMA) type 1 is a rare genetic disease caused by changes in the SMN1 gene, which is responsible for producing a protein essential for the functioning of movement-related neurons.  

The absence or deficiency of this protein causes progressive loss of muscle strength and can significantly compromise the survival of children in the first years of life.

11/25/2025  |  Precedence Research

https://www.precedenceresearch.com/news/tcs-ai-clinical-trials-platform-launch 

Tata Consultancy Services (TCS) has unveiled a cutting-edge AI-driven platform to simplify clinical trial supervision. The platform, a component of TCS's ADD Risk-Based Quality Management (RBQM) suite, provides research institutions and pharmaceutical companies with real-time insights into potential risks, enabling them to identify and resolve issues much earlier than with conventional monitoring techniques. This new approach improves accuracy in detecting trial deviations. It also supports faster decision-making through continuous data flow.

The platform includes four AI-powered modules: risk assessment, quality tolerance limits, trial analytics, and patient-level data monitoring. Because of these modules' great degree of configurability, research teams can modify them to fit various kinds of clinical studies. By doing this, the platform reduces setup time and boosts productivity throughout the clinical trial process. This flexibility significantly reduces setup time. The platform also integrates smoothly with existing clinical data systems.

In today's quickly changing research environment, traditional monitoring techniques frequently fall short, according to Rachna Malik, Global Head of TCS ADD. Sponsors can make better decisions, allocate resources more wisely, and expedite the development of novel treatments while maintaining patient safety by utilizing AI-driven insights. The approach improves coordination across global study teams. It also leads to more consistent outcomes across all trial sites.

The launch aligns with the growing adoption of AI in clinical research, particularly within India’s healthcare sector. The platform complies with global regulatory guidelines, such as ICH E6(R2) and the upcoming E6(R3), and incorporates Quality by Design (QbD) principles to ensure high-quality trials from the start. This makes the platform a critical tool for organizations aiming to enhance trial efficiency and compliance. This ensures stronger compliance and better patient safety from day one. It also makes regulatory reporting smoother and more data-driven.

As evidence of its scalability and efficacy, TCS's AI platform has already been used in more than 1300 clinical trials at 32000 locations worldwide. TCS is setting a new standard for clinical research by using AI for trial oversight, enabling the delivery of life-saving treatments more quickly, safely, and effectively. The platform is positioned as a future-ready tool for global life science companies. It marks a major step toward faster, safer, and more cost-efficient trial execution.

11/24/2025 | Digital Health News

https://saudedigitalnews.com.br/24/11/2025/brasil-tem-potencial-para-estar-entre-os-10-principais-polos-de-pesquisa-clinica-do-mundo/ 

Law 14.874/2024, along with its full regulation, has the potential to reposition Brazil on the global map of clinical research. According to an assessment by DRS Group, a company specializing in solutions for clinical studies, the new regulatory framework creates conditions for the country to join the top ten global hubs in the sector in the coming years, since this legislation modernizes and accelerates the study approval processes.

With the new rules, Research Ethics Committees (CEPs) will have 30 days to issue opinions (previously, this period was approximately 180 days). The Brazilian Health Regulatory Agency (Anvisa) will evaluate clinical protocols within 90 days. In cases of strategic research for the Unified Health System (SUS) or in health emergency situations, this period may be reduced to 15 days.

“This change represents a watershed moment for the clinical research ecosystem in Brazil. Regulatory agility increases the country's competitiveness and makes the environment much more attractive for international multicenter studies,” says David Bueno, president of DRS Group.

Currently, Brazil has a modest participation in this global market: it is responsible for only 1.8% of clinical research studies conducted worldwide, according to data from the Association of the Pharmaceutical Research Industry (Interfarma). Despite this still modest scenario, the country has characteristics considered strategic: a population of approximately 214 million people, with great genetic and cultural diversity. The association estimates that the number of studies initiated annually in Brazil could more than double, rising from 254 to 635.

Currently, Brazil ranks 20th in the world in terms of the number of studies initiated. However, the DRS Group believes this ranking could rise significantly in the next decade, a trend also favored by the strength of the local market. The country is currently the 9th largest pharmaceutical market in the world and is among the top ten countries with the largest number of pharmaceutical companies established there.

“Brazil is experiencing a decisive moment. We have a renewed regulatory framework, good research centers, and a robust pharmaceutical industry. If we can align these factors, the country could truly rank among the top ten global centers for clinical research,” emphasizes Amanda Didone, director of the DRS Group.

For the sector, the new scenario represents not only increased investment and the creation of qualified jobs, but also greater access for the population to innovative therapies, since patients can participate in cutting-edge studies conducted within the country.

11/25/2025 | Aysha Baydoun | Folha BV

https://www.folhabv.com.br/saude-e-bem-estar/anvisa-autoriza-pesquisa-clinica-da-fiocruz-com-terapia-genica-para-tratar-doenca-rara/ 

Studies will evaluate the safety and initial signs of efficacy of the product developed in partnership with a North American company.

Anvisa has authorized the start of clinical studies of a gene therapy aimed at treating spinal muscular atrophy (SMA) type 1, the most severe form of the disease. The product is being developed by the North American company Gemma Biotherapeutics, in partnership with the Oswaldo Cruz Foundation.

The research uses therapeutic gene delivery technology via viral vectors. If the safety and efficacy results are confirmed in the next stages, the drug could be used in the country for children diagnosed with SMA type 1.

Fiocruz is directly involved in the clinical development and has signed a technology transfer agreement through Bio-Manguinhos. If the product obtains registration, the institution will be able to produce the drug in Brazil, expanding national capacity in the field of gene therapies.

The authorized study is a phase 1/2 trial, focusing on evaluating safety, tolerability, and initial evidence of efficacy. The research will be conducted in at least three Brazilian clinical centers, including the Hospital de Clínicas de Porto Alegre and the Hospital das Clínicas da Unicamp.

Anvisa reported that it maintains regulatory monitoring with Fiocruz and Gemma Biotherapeutics, represented by the company Intrials Pesquisa Clínica, to ensure technical rigor and speed in the process. The initiative is part of government actions aimed at strengthening the Economic-Industrial Complex of Health and advancing the national production of advanced therapies.

SMA type 1 is caused by alterations in the SMN1 gene, responsible for producing a protein essential for the functioning of motor neurons. A deficiency in this protein causes progressive loss of muscle strength and compromises the survival of children in the first years of life.