2A+ Farma Portal de notícias
Pela sétima vez consecutiva, o laboratório vence o Prêmio Valor Inovação, um dos principais reconhecimentos de inovação do país Leia Mais »
Arquivos Mensais: outubro 2021
União Química e Geropharm assinam contrato de cooperação na área técnica e regulatória para o portfólio de insulinas no Brasil
A União Química e a farmacêutica Russa, Geropharm, umas das líderes mundiais na produção de Insulina e produtos biológicos, assinaram em 25 de outubro, em Brasília, contrato de cooperação na área técnica e regulatória para o portfólio de insulinas da Geropharm a serem comercializadas no Brasil. Leia Mais »
Addition of SGLT2 inhibitor with improved efficacy will be able to address demands of T2D market, says GlobalData
At the 57th annual European Association for the Study of Diabetes (EASD) 2021 meeting, results were presented for a 3-year prospective study. The study results demonstrated that SGLT2I, either empagliflozin (Jardiance) or dapagliflozin (Farxiga), are efficacious as part of a quadruple combination therapy with metformin, dipeptidyl peptidase-4 inhibitor (DPP-4I) and glimepiride in T2D patients. Additionally, SGLT2Is are able to address the demands of the T2D market for therapies that can be prescribed in combination to address the sub-optimal HbA1c control, says GlobalData, a leading data and analytics company.
The study examined the addition of sodium glucose cotransporter 2 inhibitor (SGLT2I) to the existing triple combination therapies in type 2 diabetes (T2D) patients that continue to have sub-optimal glycemic control.
Akash Patel, Pharma Analyst at GlobalData, comments: “Key opinion leaders (KOLs) interviewed by GlobalData have expressed significant interest in identifying further possible combination therapies that include SGLT2, especially for patients who are taking a combination of therapies but are unable to achieve optimal glycemic control or have developed additional cardiorenal comorbidities.”
The trial was a single-center, three-year, open-label, prospective observational study conducted in eligible patients ages 19 years and older who had sub-optimal glycemic control (hemoglobin A1c [HbA1c] 7.5–12.0%) despite the maximum doses of metformin, DPP-4I, and glimiperide, with stable dosage for at least three months. These patients were treated with empagliflozin at 25mg per day or dapagliflozin at 10mg per day as a fourth OAD to their existing triple combination therapy, at their physician’s discretion. A total of 262 patients were enrolled, split between empagliflozin (25mg per day, n=185) and dapagliflozin (10mg per day, n-177).
The efficacy outcomes included the change in HbA1c, fasting plasma glucose (FPG), and other cardiometabolic variables at the three-year point. The safety outcomes, hypoglycemia, volume depletion, nocturia, and genitourinary tract infections (GUTIs). The mean HbA1c reduction at the three-year point was -1.7% in the empagliflozin group versus -1.1% in the dapagliflozin group (P=0.001). There was a similar trend also observed with FPG (-59.3 ± 53.3mg/dL versus -47.4 ± 61.7mg/dL for empagliflozin and dapagliflozin, respectively, P=0.055).
The trial concluded that the efficacy of SGLTIs has been sustained for three years as part of a quadruple combination therapy. Blood glucose control was achieved more often with empagliflozin (25mg per day) than with dapagliflozin (10mg per day).
Mr. Patel concludes: “With SGLT2Is demonstrating significant efficacy in the treatment of cardiorenal comorbidities and having gained FDA and EMA approval for treatment in these areas, these inhibitors will be increasingly prescribed in both triple and quadruple combination therapies across the major markets. SGLT2Is are likely to continue to increase their T2D market share and become a leading therapeutic class.”
Source: Global Data.
FCE Cosmetique e FCE Pharma reúnem maiores nomes das indústrias cosméticas e farmacêuticas
Após quase dois anos, a FCE Cosmetique e FCE Pharma retornam para três dias de muito conhecimento, trocas de experiências e novidades dos setores Leia Mais »
MSD amplia licença parental aos casais heterossexuais, homossexuais e pais adotivos
Benefício que era de 20 dias será ampliado a partir de novembro na companhia Leia Mais »
Rayflex apresenta solução para salas limpas durante a FCE Pharma
Durante a feira, que é a mais importante de negócios para indústria farmacêutica, empresa vai destacar o modelo hi-tech, único no mercado brasileiro Leia Mais »
Boehringer Ingelheim opens high-tech tablet production facility in Ingelheim
Ingelheim, Germany, October 27, 2021 – Rhineland-Palatinate Minister President Malu Dreyer was on hand as Boehringer Ingelheim opened a new tablet production facility in Ingelheim today. Starting immediately, the Solids Launch Factory will manufacture all the company’s new drugs introduced in tablet form (solids). The facility will employ around 75 workers. Total investments in the plant amount to EUR 90 million. Leia Mais »
Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate
( Tel Aviv, Israel & Wendelsheim, Germany, )
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433.
Anle138b targets pathological alpha-synuclein oligomers and is being evaluated in patients with neurodegenerative diseases for potential disease modification. Under the terms of the agreement and pending regulatory clearance, Teva will receive an exclusive global license to develop, manufacture and commercialize anle138b and sery433. The companies will jointly develop the compounds for the multiple system atrophy (MSA) and Parkinson’s disease (PD) indications based on early-stage clinical studies, and consider exploring additional indications based on clinical outcomes.
A Phase 1 (NCT04208152) study examining anle138b in healthy volunteers completed in July 2020 demonstrated favorable benefit-risk profile at all dose levels while achieving higher plasma levels than those required for full therapeutic efficacy in animal models. Anle138b was initially developed in patients with MSA and PD and has the potential to be applied to other neurodegenerative disorders, such as Alzheimer’s disease. A Phase 1b (NCT04685265) clinical trial evaluating the safety of the compound, as well as efficacy measures in patients living with PD, is currently being conducted.
“With Teva’s strong foundation in neuroscience and our in-house expertise in neurology and psychiatry, this licensing and collaboration agreement adds a promising new compound to our early-stage pipeline as a possible orphan disease treatment for the growing patient population living with multiple system atrophy, as well as a potential option for patients living with Parkinson’s disease,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D. “We at Teva are excited about collaborating with the MODAG team and look forward to future developments as we continue to follow the science and explore additional indications for both partnered compounds.”
Dr. Matthias, CEO of MODAG added, “We are pleased to partner and work alongside Teva, an organization that has longstanding, extensive expertise in the development of therapeutics. In addition to the previous support we have received from the Michael J. Fox-Foundation and the Cure Parkinson’s Trust, this partnership further underscores the heightened potential of our lead candidates to do what no drug is currently capable of: blocking the progression of synucleinopathies. Building upon our notable preliminary results, we look forward to the continued development of anle138b alongside Teva to help patients living with currently untreatable neurodegenerative diseases, including MSA, PD and Alzheimer’s disease. With the introduction of small-molecule medication, we open a new chapter in the fight against neurodegenerative diseases and have the chance to improve the lives of millions of patients drastically.”
Multiple System Atrophy
Multiple system atrophy (MSA) is a rare neurodegenerative disorder classified clinically as “atypical parkinsonism” and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the α-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 7-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.
Com uso de embalagens feitas com fibras certificadas e rastreáveis, Laboratório Teuto conquista créditos de reciclagem da Papirus e atesta a sustentabilidade da operação
Iniciativa reforça o compromisso com a destinação correta das embalagens, como determina a Política Nacional de Resíduos Sólidos Leia Mais »
B. Braun abre as inscrições para o Programa de Trainee 2022
Empresa de soluções para o segmento de saúde busca candidatos para integrar equipe em 2022 Leia Mais »