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International News

Researchers monitor mRNA to help time its great escape to perfection

The ease by which mRNA-based drugs are taken up by cells in tissues is crucial to their therapeutic effectiveness. Now, a new detection method developed by researchers at Chalmers University of Technology, Sweden, and AstraZeneca could lead to faster and better development of the small droplets known as lipid nanoparticles, which are the main method used to package mRNA for delivery to the cells. Leia Mais »

Vaccine and therapeutic COVID-19 clinical trials showcase different trends, says GlobalData

Since COVID-19 was officially declared a pandemic by the World Health Organization (WHO), the peak in total number of clinical trials for the virus was seen in the month of April 2020. However, there has since been a steady decrease in new clinical trial investigations, except for the months of December 2020 and March 2021. As companies and organizations continue to test both vaccines and therapeutics, the total number for each are showing different trends, says GlobalData, a leading data and analytics company. Leia Mais »

Byondis Announces Positive Topline Results of Pivotal Phase III TULIP® Study in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Study Meets Primary Endpoint, Confirming the ADC [Vic-]Trastuzumab Duocarmazine (SYD985) is Superior to Physician’s Choice in Delaying Disease Progression

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Sanofi partnering with leading academic cooperative groups to study amcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer

PARIS – June 4, 2021 – Sanofi partnering with leading groups delivering practice-changing breast cancer research, the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), to initiate a pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi’s amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy.
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Eli Lilly’s tirzepatide continues to outperform popular diabetes drugs in head-to-head clinical trials, says GlobalData

Eli Lilly’s highly anticipated tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 receptor agonist (GLP-1RA), recently demonstrated that it was able to not only reduce HbA1c levels in type 2 diabetes (T2D) patients, but also confer weight loss when compared to insulin glargine in the SURPASS-4 trial. Tirzepatide has the potential to achieve blockbuster status, if approved, by helping to address the growing epidemic in T2D, inducing significant weight loss, and continuing to outperform incumbent giants in head-to-head clinical trials, says GlobalData, a leading data and analytics company.

SURPASS-4 is a randomized (2,002 study participants), parallel, open-label Phase III clinical trial investigating treatment with tirzepatide (5mg, 10mg, and 15mg) compared to insulin glargine in T2D adult patients who have an increased risk of cardiovascular disease and are inadequately controlled with oral T2D medications.

Tirzepatide successfully achieved its primary endpoint by conferring a statistically significant reduction in hemoglobin HbA1c and a further secondary endpoint of reduced body weight compared to insulin glargine. Specifically, at 52 weeks, the highest dose of tirzepatide (15mg) resulted in an A1C reduction of 2.58% and an impressive body weight reduction of 11.7 kg compared to patients treated with insulin glargine (1.44% and +1.9kg). The most common side effects for patients treated with tirzepatide were gastrointestinal in nature.

Jesse Cuaron, CVMD and GH Director at GlobalData, comments: Key opinion leaders (KOLs) interviewed by GlobalData were highly impressed after learning about the significant HbA1c and weight reduction following treatment with tirzepatide. Despite the impressive results, they voiced caution in treating certain T2D patients, for example patients with advanced diabetic retinopathy, as this population could actually experience more deterioration in association with too rapid of decline in HbA1c. Overall, KOLs expressed amazement with the multiple clinical trial data sets, including head-to-head trial data, that continue to be released by Eli Lilly, and look forward to additional worldwide clinical trial data to be released.”

Eli Lilly also revealed that tirzepatide was able to demonstrate superiority over Novo Nordisk’s Ozempic (semaglutide) and Tresiba (insulin degludec) in previous trials. Specifically, tirzepatide demonstrated reductions in both HbA1c and weight in T2D patients when compared to the GLP-1RA and second-generation basal insulin. Tirzepatide is also being studied for the treatment of non-alcoholic steatohepatitis (SYNERGY-NASH) and heart failure with preserved ejection fraction and obesity (SUMMIT).

Cuaron adds: “Overall, GlobalData believes that tirzepatide, if approved, will provide physicians and patients with a therapy that could help patients achieve HbA1c levels that are within the normal range for non-diabetic individuals (below 5.7%), while also providing Eli Lilly an edge over primary competitors, like Novo Nordisk. Its novel dual mechanism of action establishes tirzepatide as a first-in class GLP-1/GIP, and a strong contender against competitors in the T2D market.”

Marchesini Group takes part in Achema Pulse, the digital event that provides a foretaste of 2022’s international show

Pianoro (Bologna) – In the run-up to the next edition of Achema (4-8 April 2022), the industry’s first big international event after the stop imposed by the pandemic, the German show’s organisers have launched the Achema Pulse digital portal. The platform will be online throughout the month of June, with two red-letter dates, the Live Days on 15 and 16 June, when industry players will present the new process and packaging trends. Leia Mais »

World MS Day: Opportunities remain for products that fulfil significant unmet needs in the MS market, says GlobalData

The multiple sclerosis (MS) therapeutics market is becoming increasingly crowded, but the overall fulfillment of unmet needs is medium. There are no curative therapies for MS, and most existing disease modifying therapies (DMTs) are only partially effective in preventing relapses, with limited impact on the accrual of disability. This means that most patients still experience exacerbations of the disease and face the prospect of life-long treatment with MS medications, says GlobalData, a leading data and analytics company.

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Clarity Pharma secures MHRA approval for second warehouse facility

Clarity Pharma, a UK headquartered distribution partner to mid-market pharmaceutical companies around the world, has announced that a March 2021 audit saw Unit 1 of its warehousing infrastructure achieve Medical Healthcare Regulatory Agency (MHRA) licence approval. The accreditation is in compliance with the new Medical Device Regulations, which came into place in May 2020, and complements the company’s existing licence for its Unit 3 facility.

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New daily COVID-19 cases could reach 1.4 million by end of May in India, according to GlobalData

India could reach approximately 1.4 million new daily COVID-19 cases by May 24, if current transmission risk is not reduced further, according to a two-week forecast by GlobalData, a leading data and analytics company.

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Swedish Chordate Medical receives CE mark approval for neuromodulation treatment of Chronic Migraine

Chordate Medical Holding AB (publ) (“the company, or “Chordate”) is a Swedish medical technology company that has developed and patented an innovative treatment method: K.O.S. The company’s existing EC-certificate for K.O.S has now been granted an extension with the indication Chronic Migraine and the intended use: Preventive treatment of chronic migraine in adults over 18 years. The CE marking means that the K.O.S treatment meets the clinical efficacy and safety requirements for in the European Medical Devices Directive for the new indication. The approval allows Chordate to commercialize the migraine treatment within the EU. This CE marking comes one year ahead of the company’s preliminary plan.

 

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