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. What Is a Surrogate Endpoint?

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pharmaphorum

JANUARY 10, 2023

New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.

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The Pharma Data

DECEMBER 17, 2020

7, 2020 — After starting a drug that’s officially approved to treat a type of blood cancer, a young man with type 1 diabetes was able to stop using insulin. He’s been off insulin since August 2018 — more than two years. Whether this drug can help others with type 1 diabetes isn’t yet known.

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XTalks

NOVEMBER 3, 2022

Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.

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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. No serious adverse events related to the drug were reported. MASH is intricately linked to cardiovascular, kidney and metabolic disorders.

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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. STOCKHOLM , Dec.

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STAT News

DECEMBER 5, 2022

Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market , The Wall Street Journal notes. Food and Drug Administration. ” And the U.S.-based

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. While weight loss effects can vary depending on the drug, studies show that all GLP-1 meds can result in an average weight loss of about 10.5

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XTalks

MARCH 8, 2021

Eli Lilly (NASDAQ: LLY ) reported late last week that its investigational diabetes injection, tirzepatide, demonstrated superiority to Novo Nordisk’s (NASDAQ: NVO ) ozempic (semaglutide) in a Phase III trial. GLP-1 receptor agonists lower blood glucose levels by increasing the production of insulin. GLP-1 Receptor Agonists.

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The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

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Druggist

MAY 6, 2021

It is also one of the most prescribed drugs overall in the UK. As with other drugs, it is possible to experience side effects during the treament or medicine may not be suitable. Metformin can commonly cause gastrointestinal side effects and this very often leads to switching to another drug. Drug classification.

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Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The primary distinctions between biologics and small molecule drugs are their size, their structural complexity, and the way in which they are produced. Blood and blood components.

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pharmaphorum

JULY 28, 2022

The American Heart Association issued a statement last year highlighting the risks of visceral and abdominal fat (VAT), calling for clinical trials of therapies to reduce it, as well as greater efforts to encourage patients to exercise and improve their diets. Image by Bruno /Germany from Pixabay .

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion in 2022.

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The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. Click here to get Unblock My Hormones And Start Burning Fat TODAY With HB5 at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

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The Pharma Data

MAY 13, 2021

Following this program will help you lose weight fast, prevent yo-yoing, stabilize hormonal balance, and get back on track to leading a healthy life – all while never being hungry or having to go to the gym! Effects of glucose-to-fructose ratios in solutions on subjective satiety, food intake, and satiety hormones in young men.

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The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. In consultation with the U.S.

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The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S.

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The Pharma Data

MAY 14, 2021

It also forces your body to release insulin…. Which is your #1 fat-storing hormone. 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….

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The Pharma Data

DECEMBER 2, 2020

Within the scope of the ALISTAIR project, there is a unique opportunity to design, implement, and evaluate the project results to the brand-new drug production facility being setup by Diamyd Medical in Umeå, the Capital of Västerbotten County in Sweden.

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XTalks

MAY 20, 2022

Eli Lilly’s diabetes and weight loss shot tirzepatide, known by its trade name Mounjaro, received a much-anticipated nod from the US Food and Drug Administration (FDA) last week for the treatment of diabetes. Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial.

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Pharmaceutical Technology

MARCH 23, 2023

The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms.

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