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).

Insulin 98

Insulin Gene Therapy Gene Regulation 98

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.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

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.

FDA Approval 130

FDA Approval Drugs Insulin Clinical Trials 130

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.

Life Science 90

Life Science FDA Approval Insulin Drugs 90

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.

Insulin 246

Insulin FDA Approval Research Development 246

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.

FDA Approval 81

FDA Approval Insulin 81

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.

Development 196

Development Insulin Drug Delivery Production 196

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.

Insulin 52

Insulin FDA Approval Doctor Doctors 52

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.

Insulin 52

Insulin Production FDA Approval Generic Drugs 52

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

Insulin 52

Insulin FDA Approval Life Science Production 52

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%.

Sales 130

Sales Insulin Marketing FDA Approval 130

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.

Insulin 52

Insulin FDA Approval Marketing Development 52

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.

Production 130

Production Insulin FDA Approval Pharma Production 130

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.

Insulin 98

Insulin Production FDA Approval Marketing 98

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

Insulin 98

Insulin FDA Approval Doctors Doctor 98

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.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

XTalks

OCTOBER 28, 2024

Diabetes, a chronic condition marked by high blood glucose levels due to insulin issues, brings complications like heart disease, stroke, neuropathy and diabetic foot ulcers. Abbot also joined Medtronic to pair its sensors with the latter’s automated insulin delivery (AID) systems. million undiagnosed and 115.9

Insulin 105

Insulin FDA Approval Marketing Doctors 105

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.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

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.

Insulin 98

Insulin Hormones FDA Approval Sales 98

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.

Marketing 100

Marketing Insulin HR Production 100

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.

FDA Approval 52

FDA Approval Insulin Regulation Drugs 52

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.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

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.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

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.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

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.

Insulin 98

Insulin FDA Approval Production Pharmacy 98

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.

Life Science 52

Life Science FDA Approval Vaccination Vaccine 52

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.

Drugs 115

Drugs Insulin FDA Approval Sales 115

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.

Sales 98

Sales FDA Approval Production Insulin 98

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

Marketing 105

Marketing Insulin Sales Big Data 105

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!

Insulin 130

Insulin Production Development Genetics 130

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.

Drugs 121

Drugs Trials Insulin FDA Approval 121

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.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

XTalks

JULY 17, 2024

Octreotide is a synthetic analog of somatostatin, a hormone in the body that inhibits the release of several other hormones, including growth hormone (GH), glucagon and insulin. Excess GH stimulates the secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes most of the clinical manifestations of acromegaly.

Trials 59

Trials Hormones Clinical Trials Clinical Trials 59

XTalks

OCTOBER 2, 2024

The FDA-approved, OTC CGM device is designed for adults 18 years of age and older who are not taking insulin and want to monitor their glucose levels without needing a prescription. The global CGM market was valued at approximately $4.60 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of around 7.19

Insulin 52

Insulin Marketing FDA Approval Packaging 52

XTalks

FEBRUARY 21, 2024

There are currently no FDA-approved drug therapies for MASH, and the disease is characterized by excess fat accumulation and inflammation in the liver, which leads to liver scarring or fibrosis. It has been approved for treating diabetes and obesity.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

XTalks

AUGUST 30, 2024

The recent partnership to produce affordable insulin in Africa aims to reach over four million people by 2026, reflecting Novo Nordisk’s commitment to global health equity. Eli Lilly (LLY) Market Capitalization: $353.3 Billion Eli Lilly continues to strengthen its market position with innovative therapies and strategic acquisitions.

Marketing 98

Marketing Production Sales Antibody 98

pharmaphorum

APRIL 1, 2022

And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? In September of 2021, the FDA approved Byooviz , which references Roche and Novartis’ blockbuster eye drug Lucentis.

Marketing 59

Marketing Pharmacy FDA Approval Manufacturing 59