XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4

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Hormones Drugs Sales Insulin 59

pharmaphorum

APRIL 9, 2021

Provention licensed rights to teplizumab from MacroGenics in 2010, eight years after former licensee Lilly abandoned the drug in the wake of a failed phase 3 trial looking at its role in treating newly-diagnosed T1D patients. Photo by Dennis Klicker on Unsplash.

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Druggist

MAY 6, 2021

Licensed use. 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. Summary of the post: What is metformin?

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The Pharma Data

FEBRUARY 25, 2021

and Eli Lilly and Company (NYSE: LLY) announced today a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin solutions, currently in development. Lilly will commercialize the pen platform, which will include the new app and Lilly’s connected insulin pen solutions.

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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. Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

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Trials Clinical Trials Clinical Trials Insulin 59

XTalks

OCTOBER 26, 2020

Autoantibody screening involves measuring levels of islet autoantibodies (iAb) that recognize antigens found in insulin-producing pancreatic beta cells. The company began rolling submission of a biologic license application (BLA) to the FDA for teplizumab back in April.

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XTalks

FEBRUARY 8, 2021

Last year, Biocon Biologics and Mylan announced they’d be seeking interchangeable status for their long-acting insulin product Semglee , developed to be an alternative to Sanofi’s Lantus (insulin glargine). For example, ongoing patent litigation may dictate which indications are pursued for a biosimilar.

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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. It also has an option on global marketing rights to the drug.

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Drugs Insulin FDA Approval Sales 116

Velocity Clinical Research

JUNE 27, 2023

Rosenstock is the lead investigator for Novo Nordisk’s ONWARDS 1 program exploring the first investigational once-weekly insulin. “In In ONWARDS 1, insulin icodec allowed people to spend significantly more Time in Range, with comparable Time below Range vs. once-daily basal insulin glargine U100,” said Dr. Rosenstock. “A

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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).

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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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The Pharma Data

AUGUST 11, 2020

Type 1 diabetes sees patients lose insulin over time which shortens their lifespan. Abatacept preserves the pancreas’s ability to produce insulin which could help diabetics live longer. This was found in one third of patients who participated in the study.

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pharmaphorum

JUNE 14, 2021

This can lead to metabolic abnormalities including insulin resistance, diabetes, and elevated levels of blood lipids (such as high cholesterol). Eventually it was bought by Amryt who, keen to get the drug licensed, resubmitted it to NICE in 2020.

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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. Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies.

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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. .

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Pharmaceutical Technology

AUGUST 15, 2022

The country has a long history of leadership and innovation in this field, from the discovery of stem cells and insulin to the invention of the world’s first pacemaker and much more. Over the past five years, the life sciences sector produced a total of 83 commercialised or licensed products and services.

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pharmaphorum

JUNE 18, 2021

“If you imagine that every app for type 1 diabetics developed by insulin producers probably has a bolus calculator within it, every single one of those manufacturers will have built their own version of a bolus calculator, run their own tests and generated their own documentation, in silos,” according to Macpherson.

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Druggist

MAY 12, 2021

Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . Licensed use of Celevac tablets: Constipation. These advertised properties are similar to Celeva’s licensed use. What is Celevac?

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Containment Production Pharmacy Licensing 97

FDA Law Blog

NOVEMBER 16, 2021

139001 lays out a process by which the Secretary would: Identify “negotiation-eligible drugs” from among qualifying single-source drugs that are among the top 50 with the highest Part D spending, the top 50 with the highest Part B spending, and insulins. Here are the important points from the MedPac summary: Sec.

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Generic Drugs Manufacturing Drugs Licensing 52

Roots Analysis

AUGUST 1, 2024

Growing Interclass Drug Competition: The diabetes treatment market is highly competitive, comprising of various alternative therapies (including oral anti-diabetics, insulin, and other injectable medications); notably, the introduction of biosimilars is likely to impact the dynamics of this market. per package in the US.

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Marketing Insulin Drugs Development 52

Druggist

OCTOBER 4, 2020

Lepicol has a rather unique formula of three different ingredients: Psyllium husk Live bacteria Insulin (a fibre from chicory root and not the Insulin produced by the pancreatic cells) As advertised the Insulin (chicory root) is not broken down by the body, but fermented by live bacteria to support the growth of natural bacterial flora in the gut.

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Containment Pharmacy Bacteria Sales 98

The Pharma Data

MAY 4, 2021

TGA lifts suspension of Tandem t:slim X2 insulin pump, with conditions. TGA has lifted the suspension it imposed on the Tandem t:slim X2 insulin pump late last year. The Drug Regulatory Authority of Pakistan (DRAP) has stopped accepting hard copies of applications for new drug manufacturing licenses. TGA Notice , More. .

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The Pharma Data

APRIL 1, 2021

One hundred years ago, the Toronto Site was home to some of the initial research for the discovery of insulin, as well as large-scale commercial insulin production for all of Canada until the 1980s. Sanofi Pasteur’s commitment to improve influenza prevention.

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Vaccine Vaccination Manufacturing Insulin 52

BioSpace

NOVEMBER 17, 2022

Editas Medicine is pausing its ocular gene therapy program after demonstrating a favorable safety profile and seeking a potential partner to develop EDIT-101, the company announced Thursday.

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Roots Analysis

FEBRUARY 22, 2022

We observed that many companies have entered this field by in-licensing technologies from other players to establish the necessary expertise required to develop / manufacture autoinjectors. It is important to highlight that 75% of the total deals signed in 2021 ( till August ) are licensing agreements. Concluding Remarks.

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The Pharma Data

MAY 15, 2021

Description: Scientists have just discovered there’s a new, untapped reserve of insulin-producing cells hiding in the human body. The Blood Sugar Code is an online coaching program specifically designed to help you “activate” and grow new type II antidiabetic cells.

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Production Sales Insulin Doctor 52

XTalks

AUGUST 2, 2023

It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. 5) Toujeo (insulin glargine) Toujeo is very similar to Lantus in that both are insulin glargine, except Toujeo is more concentrated. Merck’s total global revenue from Lagevrio was $5.68 billion ($8.72

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FDA Law Blog

FEBRUARY 7, 2022

While we recognize that OPDP also cited the absence of “material information from the warning and precaution for hypoglycemia with concomitant use of insulin secretagogues or insulin” this was the last issue cited and likely not the basis for issuing the Untitled Letter.).

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The Pharma Data

JANUARY 7, 2021

In addition, icosabutate lowered triglyceride levels, improved insulin resistance and lowered hsCRP by an impressive 50%, biomarker changes that improve the patient’s cardiovascular risk profile.

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Engineer Insulin Development Licensing 40

FDA Law Blog

DECEMBER 3, 2023

covered insulin product or vaccine). Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. state pharmaceutical assistance programs).

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The Pharma Data

JANUARY 5, 2021

Department of Health and Human Services (HHS) authorized state-licensed pharmacists to vaccinate children age 3 and up. In April, HHS allowed licensed pharmacists to test patients for COVID-19. In August, the U.S. That followed a U.S. “We’re really trying to address those concerns.” Future depends on policy.

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The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. 25% $ 2,988.1 $ 2,459.1 22% Humalog ®(a) 607.6

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Pharma Marketing Network

OCTOBER 27, 2020

So a doctor that’s licensed stay only in the state of New York would be able to practice across the entire counties using Telemedicine. Don ( PMN): This is really interesting too and that is the one that we’ve spoken about earlier in previous conversations was the aerosolized insulin? Robin (Guest): Yup. Don ( PMN): Wow.

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Pharma Marketing Network

OCTOBER 27, 2020

So a doctor that’s licensed stay only in the state of New York would be able to practice across the entire counties using Telemedicine. Don ( PMN): This is really interesting too and that is the one that we’ve spoken about earlier in previous conversations was the aerosolized insulin? Robin (Guest): Yup. Don ( PMN): Wow.

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Insulin Doctor Doctors Marketing 52

The Pharma Data

DECEMBER 27, 2020

United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, approved by the FDA in 2014.

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XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. What Is a Surrogate Endpoint?

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