XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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pharmaphorum

MAY 16, 2022

It was also compared to a placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogues. more than placebo when used in combination with a long-acting insulin. more than insulin degludec and 1.0% more than insulin glargine. more than insulin degludec and 1.0% more than insulin glargine.

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pharmaphorum

FEBRUARY 18, 2025

Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog

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pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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XTalks

JULY 3, 2023

The treatment is derived from deceased donor pancreatic cells and is indicated for patients who are unable to achieve average blood glucose levels (glycated hemoglobin) with daily insulin injections or with continuous infusion through a pump because of repeated episodes of severe hypoglycemia (low blood sugar).

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XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. Semglee is both biosimilar to, and interchangeable with, Lantus (insulin glargine). Biosimilars are sometimes mistakenly likened to generics, but the two are not the same.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration.

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XTalks

SEPTEMBER 14, 2022

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

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Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas.

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BioSpace

JUNE 28, 2023

Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.

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Camargo

OCTOBER 14, 2020

In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device.

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The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

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XTalks

AUGUST 30, 2023

million insulin pricing settlement. The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. Hear more about the insulin pricing controversy in this episode. The states say the $13.5 The states say the $13.5

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Pharmaceutical Technology

APRIL 28, 2023

Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.0mg, for the treatment of type 2 diabetes. This represents a significant 83% increase in sales between 2022–2029, demonstrating a compound annual growth rate (CAGR) of 9%.

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XTalks

AUGUST 13, 2024

Abbott and Medtronic have struck a global partnership to make diabetes management easier for people who need regular insulin injections. Abbott’s CGM sensors will work with Medtronic’s AID algorithms to automatically adjust insulin levels based on real-time blood sugar readings. billion by 2033.

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Pharmaceutical Technology

MARCH 1, 2023

More than a century after an individual with type 1 diabetes was treated with insulin for the first time, the FDA approved Tzield, the first and only treatment to delay the onset of type 1 diabetes. Also in this month’s issue, we take a look at the innovative type 1 diabetes therapy by Provention Bio called Tzield.

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FDA Law Blog

AUGUST 12, 2021

Koblitz — About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. So, it remains to be seen if and when interchangeable Semglee will have any meaningful effect on insulin prices in the near future.

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XTalks

SEPTEMBER 3, 2020

A leader in the medical device sphere, Medtronic plc announced the release of a US Food and Drug Administration (FDA) approved device called the MiniMed 770G hybrid closed loop system. This is an insulin pump system that offers the company’s most advanced SmartGuard technology. There are 1.25

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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. In the US, it is estimated that 1.45 million people are currently living with type 1 diabetes.

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pharmaphorum

JANUARY 28, 2021

One of these markets is the insulin market. Up until now, the insulin market has experienced little competition and, as a result, prices have soared over the years. Currently, more than seven million patients rely on insulin, and that number is growing each year. But, that will soon be changing, due to biosimilars.

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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. It is the first FDA-approved SGLT2 inhibitor for any animal species.

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XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Since then, several more GLP-1 agonists have been approved by the FDA. And the demand won’t be easing anytime soon.

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XTalks

JANUARY 16, 2025

Linsitinib, an oral small molecule that targets the insulin-like growth factor-1 receptor (IGF-1R), is designed to address the underlying mechanisms driving thyroid eye disease. It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDA approval in 2020.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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XTalks

SEPTEMBER 13, 2024

As of 2024, the FDA has approved several OTC medical devices, including the Dexcom Stelo Continuous Glucose Monitor (CGM), the first OTC CGM system , which allows non-insulin users to monitor their glucose levels without a prescription.

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XTalks

APRIL 29, 2022

These bind to their respective receptors to increase glucose metabolism by increasing insulin secretion. Novo introduced a higher-dose version of Saxenda called Wegovy, which won FDA approval in 2021 for chronic weight management. Wegovy had a price tag of $1,297 a month when it was first launched.

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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XTalks

JUNE 5, 2023

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. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide.

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STAT News

NOVEMBER 18, 2022

Diabetic patients will now have easier access to insulin after the FDA approved an Eli Lilly biosimilar as interchangeable with the biologic drug , Bloomberg News notes. Rezvoglar, As of 2019, about 1.9 million people have type 1 diabetes in the U.S., Type 1 affects 8% of everyone with diabetes.

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XTalks

NOVEMBER 23, 2022

In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made.

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pharmaphorum

NOVEMBER 21, 2022

The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D.

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XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.

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XTalks

SEPTEMBER 9, 2024

Boston Scientific is transforming heart health with its less invasive treatments, and Medtronic continues to push the boundaries with advanced insulin delivery systems and real-time glucose monitoring. In its first quarter (Q1) fiscal 2025 results (which ended July 26, 2024), the company reported $7.9 Alcon (ALC) Market Capitalization: $62.6

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Pharmaceutical Technology

DECEMBER 22, 2022

Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals. In May the drug became the first medicine available in the US for eosinophilic oesophagitis following approval. Civica JAAQ Sanofi. The post Excellence Awards 2022 – Winners Announced!

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pharmaphorum

FEBRUARY 21, 2022

Since the FDA approval, Bayer has also reported the results of a second phase 3 trial – FIGARO-DKD – that concentrated primarily on cardiovascular endpoints and also includes patients with earlier-stage kidney disease.

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pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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