Insulin - Clinical Research Informer

Novo’s once-weekly insulin rejected by FDA

Bio Pharma Dive

JULY 11, 2024

The FDA’s decision to turn back the drugmaker’s new insulin product narrows Novo’s lead in the U.S. over Eli Lilly, which has a similar diabetes treatment in late-stage testing.

Insulin

Insulin Production

Lilly’s once-weekly insulin matches daily shots in late-stage tests

Bio Pharma Dive

MAY 16, 2024

The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

Insulin

Insulin Drugs

FDA advisory committee reviews Novo Nordisk insulin icodec for T1D

Pharmaceutical Technology

MAY 24, 2024

The US FDA's EMDAC is set to hold a meeting to assess the benefit-risk profile of Novo Nordisk's insulin icodec, to treat type 1 diabetes.

Insulin

California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Insulin

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

MARCH 8, 2023

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This is the second time Lilly has significantly reduced the cost of its insulin, as in 2019 the company reduced the list price of Humalog by 50%.

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Lilly to lower insulin prices by 70%

Bio Pharma Dive

MARCH 1, 2023

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

Insulin

Insulin Pharma Companies Drugs

Biden proposes subsidizing drug middlemen for insulin

World of DTC Marketing

MARCH 31, 2022

The House is preparing to vote on a $35 monthly insulin cap later, but there is stern opposition to the plan, which could cost billions over ten years. With the money it costs us, the Government could encourage a private company to build a manufacturing facility for insulin while offering tax incentives. Los Angeles Times.

Insulin

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Weekly insulin analogues approaching approval could herald change

Pharmaceutical Technology

APRIL 18, 2024

At the ongoing Diabetes UK conference, experts highlighted the potential benefits and concerns surrounding weekly insulin candidates.

Insulin

FDA rejects Novo Nordisk’s weekly basal insulin

pharmaphorum

JULY 11, 2024

FDA rejects Novo Nordisk’s once-weekly basal insulin for people with diabetes, which would reduce the number of injections needed

Insulin

Amid GLP-1 boom, Novo Nordisk strikes up insulin partnership in Indonesia

Fierce Pharma

JULY 10, 2024

While much of the attention on Novo Nordisk these days revolves around the company’s wildly popular GLP-1 drugs Ozempic and Wegovy, insulin remains a critical backbone for the drugmaker. |

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California to manufacture its own insulin, governor says

Bio Pharma Dive

JULY 11, 2022

Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.”

Insulin

Insulin Manufacturing Production Medicine

Beta Bionics’ automated insulin delivery system picks up manufacturing partner

Pharmaceutical Technology

MAY 26, 2023

Chronic disease tech company Convatec Group has partnered with Beta Bionics to manufacture the insulin delivery system iLet Bionic Pancrease. According to Beta Bionics, this is the only first and only automated insulin delivery system that carries 100% of doses and does not require carb counting.

Insulin

Insulin Manufacturing Pharmacy Marketing

Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

APRIL 18, 2024

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for (..)

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Insulin Production

Civica targets insulin in effort to produce cheaper drugs

Bio Pharma Dive

MARCH 3, 2022

The nonprofit group announced ambitious plans to begin offering insulin at prices no higher than $30 per vial by early 2024.

Insulin

Insulin Drugs

Novo Nordisk submitting once-weekly insulin to FDA following Phase III success

Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

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Insulin Trials Marketing FDA Approval

Novo Nordisk to reduce US list prices of insulin products

Pharmaceutical Technology

MARCH 15, 2023

Novo Nordisk has announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes. Novo Nordisk also has various long-standing US affordability offerings for eligible people who are living with diabetes.

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FDA Rejects Novo’s Once-Weekly Insulin Injection, Cites Manufacturing Process

BioSpace

JULY 11, 2024

The FDA’s Complete Response Letter turned down Novo Nordisk’s application for its once-weekly insulin injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.

Insulin

Insulin Manufacturing

Vertex islet cell therapy gets type 1 diabetics off insulin

pharmaphorum

JUNE 23, 2024

Three people with type 1 diabetes who received Vertex Pharma’s islet cell therapy VX-880 were able to come off insulin within a year

Insulin

Citing manufacturing issue, FDA rejects Novo Nordisk's once-weekly insulin

Fierce Pharma

JULY 11, 2024

The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. In surging to the top spot in the market cap rankings in Europe, Novo Nordisk has been on an extended winning streak. | In a complete response letter, the U.S.

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FDA Flags Hypoglycemia Risk for Novo’s Once-Weekly Insulin Ahead of Adcomm

BioSpace

MAY 22, 2024

In advance of Friday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, the FDA has raised concerns about hypoglycemia linked to Novo Nordisk’s insulin icodec, according to a briefing document.

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Insulin Drugs

Novo Nordisk’s Once-Weekly Insulin Loses FDA Adcomm Vote for Type 1 Diabetes

BioSpace

MAY 27, 2024

Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.

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Insulin Drugs

California files suit against PBMs over insulin prices

Bio Pharma Dive

JANUARY 13, 2023

The state filed suit Thursday against pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx, alleging they worked with drugmakers to drive up the price of insulin.

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Insulin Pharmacy

Meitheal partners with Chinese company for US licencing of insulin biosimilars

Pharmaceutical Technology

SEPTEMBER 21, 2023

The licence grants Meitheal marketing rights for insulin aspart, lispro, and glargine following FDA approval.

Insulin

Insulin FDA Approval Marketing

Biotts claims a first with insulin delivery across skin

pharmaphorum

MAY 1, 2024

Polish drug delivery company Biotts says it has demonstrated delivery of insulin across the skin for the first time without the use of an injection system.

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Insulin Drug Delivery Drugs

FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin

Fierce Pharma

APRIL 29, 2024

For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,

Insulin

Novo to Discontinue Long-Acting Insulin Injection Levemir by the End of 2024

BioSpace

NOVEMBER 8, 2023

Citing manufacturing concerns and formulary losses, Novo Nordisk will discontinue its long-acting insulin Levemir by the end of next year amid strong pressure from U.S. lawmakers to lower insulin prices.

Insulin

Insulin Manufacturing

As Sales of Weight Loss Drugs Skyrocket, the Insulin Market Falters

BioSpace

MAY 14, 2024

Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?

Insulin

Insulin Marketing Sales Drugs

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

JANUARY 10, 2023

In addition, market growth will be driven by dapagliflozin (Farxiga) in the SGLT-2I space, and novel GLP-1/GIP Mounjaro (tirzepatide), biosimilar/interchangeable insulins such as insulin lispro and insulin glargine (Basaglar), and the launch of once-weekly insulins icodec and Icosema, forecast for 2024 launch.

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FDA delays approval of Novo Nordisk’s weekly insulin until requests are met

BioPharma Reporter

JULY 16, 2024

Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.

Insulin

Insulin Manufacturing Regulation Marketing

Risk adjusted net present value: What is the current valuation of Novo Nordisk’s (Insulin icodec + Semaglutide)?

Pharmaceutical Technology

MARCH 13, 2024

(Insulin icodec + Semaglutide) is a recombinant peptide and recombinant protein commercialized by Novo Nordisk, with a leading Phase III program in Type 2 Diabetes.

Insulin

Insulin Protein

Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Fierce Pharma

MARCH 22, 2024

. | With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market. It was one of several opinions handed down by the CHMP.

Insulin

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There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2022

The most effective way for people with diabetes to deliver insulin is also incredibly intrusive. Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance.

Insulin

Insulin Hormones Scientist Clinical Trials

Why the drug pricing debate is focused on insulin

pharmaphorum

APRIL 13, 2022

The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. Ben Hargreaves looks at why insulin’s price is so controversial and whether this could be set to change. Insulin rationing. In the US, approximately 37.3

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Insulin Drugs Production Hormones

California sues insulin producers and PBMs over pricing

pharmaphorum

JANUARY 13, 2023

The ‘big three’ insulin producers Novo Nordisk, Eli Lilly, and Sanofi are being sued by the state of California for allegedly working together to set artificially inflated prices for their products. The suit follows legal action over insulin pricing taken by other states, including Arkansas , Kansas, Mississippi, and Minnesota.

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Insulin Manufacturing Production Pharmacy

California enters a contract to make its own affordable insulin

NPR Health - Shots

MARCH 19, 2023

Under the $50 million deal, the state is partnering with drugmaker Civica to start making the new generic insulin later this year, Gov. Gavin Newsom said. Image credit: Damian Dovarganes/AP)

Insulin

Could insulin come in a pill? How a molecule that mimics insulin may advance diabetes research

Medical Xpress

DECEMBER 12, 2022

WEHI researchers in Melbourne have answered a 100-year-old question in diabetes research: can a molecule different to insulin have the same effect? The findings provide important insights for the future development of an oral insulin pill.

Insulin

Insulin Research Development

In address to Congress, Biden touts drug pricing law and pushes insulin cost caps

Bio Pharma Dive

FEBRUARY 8, 2023

In a State of the Union address, Biden threatened to veto any efforts to repeal the legislation and chastised drugmakers for the current costs of insulin.

Insulin

Insulin Drugs

Too much insulin can be as dangerous as too little

Medical Xpress

APRIL 21, 2023

Just over a century has passed since the discovery of insulin, a time period during which the therapeutic powers of the hormone have broadened and refined. Insulin is an essential treatment for type 1 diabetes and often for type 2 diabetes, as well. million Americans use insulin, according to the American Diabetes Association.

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Insulin Hormones

Fraudulent Eli Lilly Twitter Account Announces Free Insulin

XTalks

NOVEMBER 15, 2022

In Lilly’s case, the fake account claimed the company was giving out free insulin. A fraudulent Eli Lilly account with the username @EliLillyandCo tweeted a message on November 10 that said: “We are excited to announce insulin is free now.”. On average, it is estimated that insulin costs about $98.70 percent, or by $16.08

Insulin

Insulin Sales Branding Production

Novo Nordisk taps Aspen to help produce insulin for Africa

Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk, following a similar move by its diabetes rival Eli Lilly, is teaming up with Aspen Pharmacare to shore up insulin supplies in Africa, which currently imports more than 80% of its medi | Novo Nordisk is teaming up with Aspen Pharmacare to shore up insulin supplies in Africa, which currently imports more than 80% of its medicine.

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Insulin Medicine

How buying Canadian insulin aids Americans without medical coverage

pharmaphorum

DECEMBER 11, 2023

How buying Canadian insulin aids Americans without medical coverage Mike.Hammerton Mon, 11/12/2023 - 09:00 Bookmark this

Insulin

Eli Lilly agrees to provide free and lower-priced insulin in Minnesota to resolve 2018 lawsuit

Fierce Pharma

FEBRUARY 8, 2024

The company will provide its insulin products at $35 per month and donate free insulin at 15 clinics over the next five years. After reaching a settlement with Minnesota’s attorney general, Eli Lilly can close the book on a yearslong lawsuit in the state. |

Insulin

Insulin Production

How Payers Are Reacting to Insulin Price Changes

Drug Channels

SEPTEMBER 15, 2023

Nicole summarizes MMIT’s research on payers’ views of two crucial market changes: (1) the Inflation Reduction Act of 2022’s requirement to cap insulin prices at $35 for Medicare beneficiaries, and (2) manufacturers’ reduction in list prices for certain insulin products.

Insulin

Insulin Manufacturing Drugs Production

Medtronic drops $738m takeover of wearable insulin pump firm

pharmaphorum

DECEMBER 7, 2023

Medtech giant Medtronic has decided not to go ahead with a planned acquisition of EOFlow, a developer of patch-based insulin pumps, saying that there have been “multiple breaches” of their takeover agreement.

Insulin

Insulin Development

Novo’s once-weekly insulin rejected by FDA

Lilly’s once-weekly insulin matches daily shots in late-stage tests

Trending Sources

FDA advisory committee reviews Novo Nordisk insulin icodec for T1D

California’s low-cost insulin plans receive $100m manufacturing boost

Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Lilly to lower insulin prices by 70%

Biden proposes subsidizing drug middlemen for insulin

Weekly insulin analogues approaching approval could herald change

FDA rejects Novo Nordisk’s weekly basal insulin

Amid GLP-1 boom, Novo Nordisk strikes up insulin partnership in Indonesia

California to manufacture its own insulin, governor says

Beta Bionics’ automated insulin delivery system picks up manufacturing partner

Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Civica targets insulin in effort to produce cheaper drugs

Novo Nordisk submitting once-weekly insulin to FDA following Phase III success

Novo Nordisk to reduce US list prices of insulin products

FDA Rejects Novo’s Once-Weekly Insulin Injection, Cites Manufacturing Process

Vertex islet cell therapy gets type 1 diabetics off insulin

Citing manufacturing issue, FDA rejects Novo Nordisk's once-weekly insulin

FDA Flags Hypoglycemia Risk for Novo’s Once-Weekly Insulin Ahead of Adcomm

Novo Nordisk’s Once-Weekly Insulin Loses FDA Adcomm Vote for Type 1 Diabetes

California files suit against PBMs over insulin prices

Meitheal partners with Chinese company for US licencing of insulin biosimilars

Biotts claims a first with insulin delivery across skin

FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin

Novo to Discontinue Long-Acting Insulin Injection Levemir by the End of 2024

As Sales of Weight Loss Drugs Skyrocket, the Insulin Market Falters

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

FDA delays approval of Novo Nordisk’s weekly insulin until requests are met

Risk adjusted net present value: What is the current valuation of Novo Nordisk’s (Insulin icodec + Semaglutide)?

Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

Why the drug pricing debate is focused on insulin

California sues insulin producers and PBMs over pricing

California enters a contract to make its own affordable insulin

Could insulin come in a pill? How a molecule that mimics insulin may advance diabetes research

In address to Congress, Biden touts drug pricing law and pushes insulin cost caps

Too much insulin can be as dangerous as too little

Fraudulent Eli Lilly Twitter Account Announces Free Insulin

Novo Nordisk taps Aspen to help produce insulin for Africa

How buying Canadian insulin aids Americans without medical coverage

Eli Lilly agrees to provide free and lower-priced insulin in Minnesota to resolve 2018 lawsuit

How Payers Are Reacting to Insulin Price Changes

Medtronic drops $738m takeover of wearable insulin pump firm

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