XTalks

NOVEMBER 23, 2022

Find out more about the drug and how it may be a gamechanger for type 1 diabetes. Read the full articles here: Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. In 2023, Ozempic was the 13 th best-selling drug globally.

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XTalks

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has recently cleared for marketing an app called Tidepool Loop which can be used with compatible devices for automated insulin dosing (AID). The Tidepool loop app involves three integral parts: an integrated continuous glucose monitor (iCGM), a controller and an insulin pump.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Provention Bio came to a commercialization agreement with Sanofi last month to market the drug in the US.

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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. That leaves three years for pharma companies to prepare.

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XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. The drug is taken once a day in conjunction with diet and exercise. What is the Animal Drug Regulatory Process?

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Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. With over 150 pharma services/supply companies and 19 universities, Scotland is one of the most advanced life science sectors in the UK and the world.

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XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

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XTalks

JANUARY 16, 2023

Novo Nordisk announced in a press release last week that a label update for their type 2 diabetes treatment Rybelsus (semaglutide) was approved from the US Food and Drug Administration (FDA). Often, diabetes medication or insulin therapy are used as management tools.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

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Roots Analysis

JANUARY 23, 2024

The peptide therapeutics market has undergone substantial evolution since the inception of insulin. Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases. Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases.

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Pharmaceutical Technology

DECEMBER 22, 2022

The main focus is the antibody-drug conjugate (ADC ), Enhertu (trastuzumab deruxtecan), which had already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma.

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XTalks

SEPTEMBER 15, 2020

In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.

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XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness.

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XTalks

DECEMBER 14, 2022

CGMs can alert diabetics sufficiently in advance of too high or low blood glucose levels, allowing the wearer to improve the situation with insulin, for example. The CGM can be integrated with insulin delivery systems and connected to devices like Apple watches and popular health apps. Dexcom, Inc. , a cellphone) every five minutes.

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XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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XTalks

OCTOBER 11, 2023

While the link between GLP-1 inhibitors and gastrointestinal side effects has been known for diabetics taking the drugs, this is the first study that was conducted among non-diabetics taking them for weight loss. Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes.

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XTalks

OCTOBER 22, 2021

The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition.

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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

DECEMBER 15, 2022

In September 2021, the US Food and Drug Administration (FDA) issued a partial US clinical hold on the phase III DIAGNODE-3 clinical trial of the drug. The primary endpoints of DIAGNODE-3 are: preservation of endogenous insulin producing capacity measured as stimulated C-peptide; and.

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Roots Analysis

MARCH 21, 2022

However, several drug delivery devices that enable patients to self-administer their respective medications are now available. Biologics have emerged as a direct consequence of the rapid development that has taken place in the field of life sciences, particularly in cell and molecular biology, over the past few decades.

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XTalks

MAY 13, 2021

While AbbVie’s anti-inflammatory Humira has led pharma TV ad spending for a good part of the past year, the top pharma ads this week included diabetes drug ads from Eli Lilly and Novo Nordisk. The drug is a human glucagon-like peptide-1 (GLP-1) agonist that functions to increase insulin secretion from the pancreas.

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XTalks

JULY 3, 2023

Making for another landmark cell and gene therapy approval this month, the US Food and Drug Administration (FDA) has signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes. Lantidra is thought to increase insulin secretion through the infusion of allogeneic insulin-producing islet beta cells.

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XTalks

AUGUST 25, 2023

After seeking approval in May to settle litigations over pricing of its insulin product Humalog, Eli Lilly is facing resistance from nine US states who are asking a New Jersey federal court to delay approval of the proposed $13.5 US insulin makers have come under fire as the US is the country with the most expensive insulin in the world.

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XTalks

SEPTEMBER 22, 2020

A new study shows that the diabetic drug canagliflozin reduces the risk of adverse cardiovascular and kidney outcomes in individuals with type 2 diabetes, particularly for those at higher risk of kidney failure. Related: New Drug Treatment Shows Efficacy for Lupus Kidney Disease.

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . ” About the author .

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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

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?

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The Pharma Data

JANUARY 5, 2021

Novasep’s chromatography unit comprises resin-based batch and intensified chromatography systems, and primarily focuses on high-pressure, multi-use applications for smaller molecules, such as oligonucleotides, peptides and insulin. 6,200 people, and earned sales revenue of 1,440.6 million euros. www.sartorius.com. About Novasep.

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XTalks

APRIL 29, 2021

According to the US Food and Drug Administration ( FDA ), in the past 5 years, 76 percent of all clinical trial participants were Caucasians, while diverse populations such as Africans and Asians only composed 11 percent and 5 percent, respectively. Despite this, ethnic minorities are underrepresented in clinical trials.

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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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Delveinsight

JULY 21, 2021

The Medications include conventional Disease-modifying antirheumatic drugs (DMARDs), Biologics DMARDs, targeted synthetic DMARDs, and others. Systemic Lupus Erythematosus (SLE), Cutaneous lupus (or Discoid lupus erythematosus), Drug-induced lupus, Neonatal lupus are the most common types of lupus. Diabetes Type 1.

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Drug Discovery World

SEPTEMBER 6, 2022

There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. Among these include Zolgensma, Novartis’ gene therapy drug for spinal muscular atrophy (SMA), which made headlines in the UK for its £1.79 million price point per dose.

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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, a 26.55

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XTalks

MARCH 8, 2021

Lilly and Novo are longtime competitors in the diabetes drug arena, particularly in the development of glucagon-like peptide-1 (GLP-1) receptor agonist drugs. GLP-1 receptor agonists lower blood glucose levels by increasing the production of insulin. GLP-1 acts on GLP-1 receptors on insulin-producing pancreatic ?

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pharmaphorum

OCTOBER 2, 2020

Beyond this, there are other factors within the control of the healthcare and life sciences industries that will determine how ubiquitous self care actually becomes. For example, Stenmark says that boosting health literacy is both the top driver and the biggest barrier to further adoption.

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