Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

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Pharmaceutical Technology

MARCH 28, 2023

Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D).

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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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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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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

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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Drug Discovery World

JANUARY 15, 2024

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3. Babies born at less than 28 weeks gestational age have low levels of IGF-1 and face high risk of severe bronchopulmonary dysplasia (BPD), which may lead to chronic lung disease.

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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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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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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

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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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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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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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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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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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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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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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

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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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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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

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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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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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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The Pharma Data

APRIL 1, 2021

Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. The survey included 1,000 U.S. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. About Type 2 Diabetes and Cardiovascular Disease.

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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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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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pharmaphorum

SEPTEMBER 1, 2020

The first was insulin – Frederick Banting and colleagues managed to isolate insulin that could treat diabetes, up until that point a fatal condition. The period between 1918 and 1939 was marked by two breakthroughs that presaged the arrival of the pharma industry as we know it today.

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Drug Discovery World

SEPTEMBER 6, 2022

CellTrans is currently awaiting an FDA decision for its cell therapy Lantidra, a treatment for patients with brittle type 1 diabetes mellitus whose symptoms cannot be well managed despite insulin therapy. Another area that can be tough to manoeuvre is IP, as we saw recently over the disputes surrounding CRISPR. Workforce .

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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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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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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

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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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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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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