pharmaphorum

JULY 7, 2021

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

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XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. It’s much needed. It’s a hot area.”

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XTalks

JUNE 3, 2021

The study , published yesterday in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism , revealed that two helpings of fruit led to higher measures of insulin sensitivity than those who ate less than half a serving. Diabetes is a growing health problem globally. Keep it Fresh.

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pharmaphorum

MAY 21, 2021

Arecor’s own lead product is an ultra-rapid acting insulin, which the company hopes will outperform market rivals from the likes of Eli Lilly, Sanofi and Novo Nordisk. Codenamed AT247, the product has a novel meal-time insulin formulation, which significantly accelerates insulin absorption post injection.

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XTalks

JULY 15, 2024

The drug has been evaluated in five clinical trials for PBH. Congenital HI is a genetic disorder that causes excessive insulin production by the pancreas, which lowers plasma or blood sugar. This action helps mitigate hypoglycemia by reducing insulin secretion and stabilizing glucose levels.

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XTalks

JULY 15, 2024

The drug has been evaluated in five clinical trials for PBH. Congenital HI is a genetic disorder that causes excessive insulin production by the pancreas, which lowers plasma or blood sugar. This action helps mitigate hypoglycemia by reducing insulin secretion and stabilizing glucose levels.

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FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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pharmaphorum

MARCH 21, 2022

Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status. Teplizumab is thought to work by binding to CD3, preventing the activation of T cells that attack and kill insulin-producing pancreatic beta cells in the autoimmune disease.

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Pharmaceutical Technology

MARCH 23, 2023

It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%).

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The Pharma Data

MARCH 3, 2022

Patients taking the oral blood pressure medication not only required less daily insulin two years after first diagnosis of the disease, but also showed evidence of surprising immunomodulatory benefits. Type 1 diabetes is an autoimmune disease that causes loss of pancreatic beta cells, which produce endogenous insulin.

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XTalks

FEBRUARY 6, 2024

Revita, an outpatient endoscopic procedural therapy, which aims to eliminate insulin needs and enhance glycemic control by ablating dysfunctional duodenal mucosa. Fractyl Health has initiated discussions with European regulators to establish an investigational new drug (IND)-enabling pathway for RJVA-001 in the treatment of T2D.

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pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

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pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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pharmaphorum

OCTOBER 9, 2022

The possible merger has been announced a few months after Nektar was forced into a major restructuring programme following the failure of its Bristol-Myers Squibb-partnered immuno-oncology candidate bempegaldesleukin which was discontinued in April after it failed late-stage trials.

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XTalks

JANUARY 21, 2025

The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers. In a clinical trial, participants demonstrated a 98% success rate after six months post implantation, with arteries widened successfully and no stent fractures observed.

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The Pharma Data

JANUARY 19, 2021

The analysis of 23 small trials found that low-carb diets worked better than other eating plans in helping people lose weight and send their type 2 diabetes into remission. The vast majority have type 2 diabetes — which arises when the body loses its sensitivity to the blood-sugar-regulating hormone insulin. TUESDAY, Jan.

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Delveinsight

AUGUST 20, 2020

regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) letter, which could cause a significant delay for any future approval, and canceled what would have been the first-ever approval for gene therapy in the bleeding disorder. J&J has agreed to pay USD 52.50

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XTalks

JANUARY 25, 2023

Brenzavvy’s approval was based on an impressive amount of data collected from 23 clinical trials involving over 5,000 patients with type 2 diabetes. A drug intended for use in animals is called a new animal drug and the FDA’s Center for Veterinary Medicine (CVM) approves and regulates new animal drugs.

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The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

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pharmaphorum

JUNE 2, 2022

This is why the action by the US in 1983 and subsequently the European Commission Regulation No. 141/2000 (the Orphan Regulation), that both acted to encourage development in the area, are regarded as crucial for changing the landscape in rare disease R&D. It is estimated that between 3.5 The price is right. Reaching a compromise.

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The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Scientists documented a significant depletion of long-lived plasma cells, a reduction of interferon type I activity, and a down-regulation of T-cell transcripts associated with chronic inflammation. Bioelectronic Platform.

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XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor.

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Scienmag

DECEMBER 3, 2020

Researchers from the University of Copenhagen and biotech firm Gubra have developed a new insulin molecule that will make blood sugar regulation both easier and safer for those with type 1 diabetes Everyday life for the more than 46 million people around the world who suffer from type 1 diabetes could become much easier and […].

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XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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XTalks

NOVEMBER 9, 2022

Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion.

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XTalks

FEBRUARY 8, 2024

In its 2022 financial report, Sanofi reported that sales of the long-acting insulin dropped 27.6 percent in the US, impacted by prior formulary losses as well as “erosion of the basal insulin market,” the company said in the statement. In its 2022 financial report, Sanofi reported that sales of the long-acting insulin dropped 27.6

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Druggist

MAY 6, 2021

Beta-cells : cells present in the pancreas, which produce insulin. Insulin: a hormone that allows glucose (sugar) to be used for energy in the body. Lastly, metformin improves sensitivity to insulin (Wiernsperger & Bailey, 1999), which regulates body sugar levels. Metformin does not increase insulin release.

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pharmaphorum

DECEMBER 14, 2020

Armed with new data from a randomised clinical trial, one company is hoping to change that mindset. The company is FriendsLearn – based in India and with an R&D office in San Francisco – which recently reported results from a trial showing that its fooya! In fooya!,

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XTalks

JUNE 10, 2024

Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. It not only reduces liver fat and inflammation but can also reverse fibrosis, enhance insulin sensitivity and improve lipid profiles.

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The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. 2)% Alimta 610.6

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The Pharma Data

MAY 14, 2021

It also forces your body to release insulin…. It’s almost impossible to burn fat in the presence of insulin…. Because insulin BLOCKS AMPk. Your body releases insulin and resistin…. Both insulin and resistin block AMPk from being released…. And serves as your body’s “master regulating switch.”

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The Pharma Data

JUNE 8, 2023

”No matter the individual, all had increased taurine levels after exercise, which suggests that some of the health benefits of exercise may come from an increase in taurine,” Yadav says.Only a randomized clinical trial in people will determine if taurine truly has health benefits, Yadav adds. ” Source link: [link]

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The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. People with type 1 diabetes cannot produce insulin.

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Delveinsight

AUGUST 25, 2021

They are governed by a number of rules and regulations that govern drug patenting, testing, safety, efficacy, and marketing. . There are 23 therapies and vaccines in total that are in Phase II of clinical trials. However, AbbVie is pacing up the trials of its other drug assets as the patent expiration for Humira is approaching fast.

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