RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Labelling Dosage Immunization Immunity 40

Pharmacy Times

JANUARY 16, 2023

Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.

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Labelling Diabetes 49

STAT

JANUARY 25, 2024

last year after taking suspected fake versions of Novo Nordisk’s diabetes drug Ozempic , Reuters reports, citing data from America’s Poison Centers. One Ozempic and similar diabetes medicines have been increasingly used off label for weight loss. Food and Drug Administration to identify public health risks.

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Labelling Diabetes Compounding 242

STAT

OCTOBER 4, 2023

The head of Eli Lilly’s burgeoning diabetes and obesity franchise is retiring at the end of the year, The Wall Street Journal notes. Mike Mason, executive vice president and president of Lilly Diabetes & Obesity, is leaving after 34 years with the drugmaker. Continue to STAT+ to read the full story…

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Diabetes Labelling 256

STAT

MARCH 11, 2024

Food and Drug Administration approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment , STAT notes. The  And of course, do keep in touch. … The U.S.

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Labelling Documentation Diabetes 265

pharmaphorum

APRIL 19, 2021

After announcing plans to go public, prescription digital therapeutics (DTx) firm Better Therapeutics has begun a “real world” study to test whether its BT-001 prescription cognitive behavioural therapy tool could change behaviours that are the root cause of type 2 diabetes. . If positive the data could support a filing with the FDA.

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Diabetes Labelling 72

STAT

APRIL 6, 2023

Novo Nordisk’s drug Wegovy is FDA-approved for weight loss in adults, while the company’s drug Ozempic is approved to treat diabetes but is also prescribed off-label for weight loss. 

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Labelling Diabetes 248

Pharmaceutical Technology

SEPTEMBER 1, 2023

Bayer adds three new Phase III heart failure studies to the Kidney and type 2 diabetes drug, Kerendia, clinical development programme.

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Labelling Diabetes 52

pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The post Provention faces delay in FDA review of diabetes prevention antibody appeared first on.

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Diabetes Labelling 98

STAT

AUGUST 18, 2023

Enjoy, and see you soon … Weight loss and diabetes medications are priced much higher in the U.S. than in other countries , CNN says, citing an analysis from KFF. Wegovy topped the list, costing $1,349 in the U.S., four times the price in Germany. A one-month supply of Mounjaro in the U.S. Ozempic costs $936 in the U.S.,

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Diabetes Labelling 243

PharmaShots

JUNE 28, 2023

Xigduo XR was approved in the US, Australia & other regions Ref: AstraZeneca | Image: AstraZeneca Related News:- AstraZeneca's Farxiga and Xigduo XR Receives FDA's Expanded Label Approval for Type 2 Diabetes (T2D) and Moderate Renal Impairment PharmaShots! For more information connect with us at connect@pharmashots.com

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Diabetes Labelling 40

STAT

NOVEMBER 15, 2023

… The German drug regulator is considering an export ban on Novo Nordisk’s diabetes drug Ozempic, which is in high demand for weight-loss, as European health systems grapple to stem a supply shortage , Reuters writes.

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Diabetes Labelling 260

STAT

JULY 26, 2024

The European Medicines Agency backed the use of Novo Nordisk’s Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes , Reuters notes. Novo plans to add the prescribing information on the Wegovy label in the EU within about one month. regulator, while the U.S.

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Labelling Diabetes 281

pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease.

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Labelling Diabetes 71

STAT

SEPTEMBER 13, 2024

insurer is taking an unusually hard line on doctors who it says improperly prescribed the diabetes treatment Ozempic, escalating the ongoing war over drugs that have become wildly popular for weight loss , Bloomberg News reports. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon… A major U.S.

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Medical Records Labelling Diabetes Drug Pricing 254

Pharmacy Times

JULY 11, 2023

The updated label for inclisiran (Leqvio) includes patients with comorbidities, such as hypertension and diabetes, who have yet to experience a cardiovascular event.

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Labelling Diabetes 20

pharmaphorum

JUNE 28, 2021

AstraZeneca’s fast-growing SGLT2 inhibitor Forxiga could soon get a further boost from approval in the EU as a treatment for chronic kidney disease (CKD) in adults with and without type-2 diabetes. The post AZ closes in Forxiga kidney disease label in EU after nod from CHMP appeared first on.

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Labelling Diabetes 54

European Pharmaceutical Review

JULY 26, 2023

The oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor is the first type 2 diabetes medicine to include cardiovascular death risk reduction data for patients with type 2 diabetes and cardiovascular disease in its label in several countries.

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Diabetes Labelling Hospitals 98

Pharmaceutical Technology

SEPTEMBER 7, 2022

The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). The post Diabetic macular oedema market expected to grow to $11.1bn globally by 2031 appeared first on Pharmaceutical Technology.

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Diabetes Biosimilars Labelling 52

STAT

AUGUST 3, 2023

For a while, these off-label prescriptions were getting covered without any issues. The lawsuit filed by Jacklyn Bjorkland, who says she was “severely injured” after taking the two diabetes drugs, is the first to allege the medicines can cause gastrointestinal injuries.

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Labelling Diabetes 234

Pharmaceutical Business Review

JULY 15, 2024

This asset has potential applications in diabetic macular oedema (DME) and neovascular age-related macular degeneration (NVAMD). The acquisition includes EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway.

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Research Laboratories Diabetes Labelling 59

PharmaShots

JUNE 28, 2023

Shots: Based on the ongoing review of inspection findings at a third-party filler, the US FDA granted a CRL for the BLA filed by the company for aflibercept (8mg) as a treatment option for patients with wAMD, DME & DR There were no issues identified with the clinical efficacy, safety, trial design, labeling, or drug substance manufacturing for (..)

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Diabetes Biosimilars Labelling 40

European Pharmaceutical Review

JULY 31, 2024

billion in 2023 for its obesity and diabetes blockbuster drugs Ozempic (off-label for obesity) and Wegovy respectively, facilitated the growth. Similar to Novo Nordisk, Eli Lilly’s obesity and diabetes drugs Mounjaro (off-label for obesity) and Zepbound propelled revenue growth to “$34.1 percent to $33.7 billion and $4.6

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Diabetes Labelling 52

Pharmacy Times

SEPTEMBER 12, 2022

Modification is based on phase 3 FIGARO-DKD clinical trial investigating CV and kidney outcomes in more than 13,000 patients with CKD associated with type 2 diabetes.

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Labelling Diabetes 29

Express Pharma

JUNE 10, 2024

The data showcases Vabysmo’s efficacy in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), as well as the Swiss pharma major’s eagerness to establish the prescription injection as a leading therapy for multiple ophthalmology indications, says GlobalData.

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Diabetes Labelling 102

Pharmaceutical Technology

NOVEMBER 25, 2022

In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.

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Diabetes Labelling 111

pharmaphorum

OCTOBER 4, 2022

Danish company Novo Nordisk have announced positive results from the ONWARDS 5 phase 3 trial, with once-weekly insulin icodec demonstrating superior reduction of HbA1 in people with type 2 diabetes, in combination with a dosing guide app. Diabetes is one of the most prevalent health conditions in the US, affecting over 11% of the population.

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Diabetes Labelling 59

Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

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Diabetes Labelling 52

RX Note

JUNE 10, 2023

Introduction The treatment approach for type 2 diabetes mellitus has undergo a shift from the traditional glucose-centric approach to the new cardiorenal-metabolic approach. This change emphasizes a comprehensive approach for reducing the risk of diabetes-related complications.

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Diabetes Labelling Hospitals 52

The Pharmacist

OCTOBER 20, 2023

Pre-filled pens falsely labelled as Ozempic have been identified in the UK supply chain, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed. The pens were identified before reaching UK patients, and all affected pens have now been recalled and accounted for, the MHRA said.

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Labelling Diabetes 119

pharmaphorum

NOVEMBER 15, 2021

It enrolled patients with and without type 2 diabetes and heart failure, to see whether treatment with Invokana (canagliflozin) can improve their symptoms, function and quality of life compared to placebo. billion in 2016 before the product was linked to an increased risk of lower limb amputation.

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Diabetes Labelling 105

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. The significant sales growth of Ozempic reinforces its continued dominance in the type 2 diabetes market.

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Diabetes Dosage Compounding Labelling 52

pharmaphorum

JULY 1, 2022

On the heels of approvals in the US, Europe and Japan, Bayer’s Kerendia for chronic kidney disease (CKD) associated with type 2 diabetes has been cleared for use in China, unlocking another big market for the drug. The post Bayer grabs Chinese okay for CKD therapy Kerendia appeared first on.

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Diabetes Labelling 52

Pharmaceutical Technology

MAY 29, 2023

The tablet can be used by adults with heart failure or chronic kidney disease, type 2 diabetes mellitus and other cardiovascular risk factors. It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.

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Labelling Diabetes Hospitals 98

Pharmaceutical Technology

MARCH 29, 2023

Emerging treatment options for obesity and diabetes are indeed proliferating in response to growing demand, but their ability to maintain weight loss will be a key factor in determining their attractiveness for use. Ozempic is currently approved for glycemic control in type 2 diabetes. Following the announcement, Brian Lian, Ph.D,

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Diabetes Dosage Labelling 105

pharmaphorum

MARCH 3, 2022

The findings – published today in the journal Nature Medicine – come after Jardiance was approved for chronic heart failure with reduced ejection fraction (HFrEF) last year, with the label expanded to include patients with heart failure with preserved ejection fraction (HFpEF) last month. It has been used to treat type 2 diabetes since 2014.

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Labelling Diabetes Hospitals 98

Big Molecule Watch

JULY 5, 2023

Regeneron added that “[t]he CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested.”

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Diabetes Labelling 62