Diabetes and Labelling - Pharmacist Digest

How the FDA’s new nutrition labels could prod the food industry to get healthier

STAT

JANUARY 15, 2025

A new government proposal to display nutritional labels on the front of food packaging is aimed at helping Americans make more informed choices about what they eat. An eventual side effect, research and expert commentary suggests, could be nudging the food industry to make healthier food, too.

Labelling

Labelling Packaging Diabetes

STAT+: Pharmalittle: Lilly diabetes drug back on shelves after two-month shortage; AbbVie sued for human rights violations over Humira pricing

STAT

FEBRUARY 22, 2023

… Eli Lilly says that all doses of its new Mounjaro diabetes drug are now available after social-media enthusiasm about weight-loss benefits sparked a two-month-long shortage , Bloomberg News tells us. last May to help people with type 2 diabetes control their blood sugar levels. The drug was approved in the U.S.

Diabetes

Diabetes Labelling

Weight loss drugs without a prescription? Study warns it’s a ‘very risky business’

STAT

AUGUST 2, 2024

In the face of ongoing shortages of the obesity and diabetes medications known as GLP-1s, patients have resorted to a wide array of sources for the drugs, including medical spas and telehealth sites that prescribe compounded versions of the drugs. One sample also contained signs of potential bacterial contamination during manufacturing.

Online Pharmacies

Online Pharmacies Labelling Compounding Diabetes

Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression

Express Pharma

JANUARY 29, 2025

The US FDA has approved Novo Nordisk’s Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD), the Danish drugmaker said on Tuesday.

Diabetes

Diabetes Labelling

STAT+: Pharmalittle: We’re reading about fake Ozempic, the FTC policing pharma, and more

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.

Labelling

Labelling Diabetes Compounding

STAT+: With weight loss drug ads, telehealth companies wade into a regulatory gray area

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.

Labelling

Labelling Diabetes

STAT+: Pharmalittle: FDA finds ‘potential systemic bias’ in Amgen cancer drug trial; drugmakers organize to push back on antitrust reviews

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…

Diabetes

Diabetes Labelling

Counterfeit diabetes pens identified in EU and UK

European Pharmaceutical Review

OCTOBER 19, 2023

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany.

Diabetes

Diabetes Labelling

STAT+: Pharmalittle: We’re reading about Wegovy approved for heart risks, an ALS drug puzzle, and more

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.

Labelling

Labelling Documentation Diabetes

STAT+: Pharmalittle: Weight loss drugs cost much more in the U.S.; PBMs win a key victory over an Oklahoma law

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.,

Diabetes

Diabetes Labelling

STAT+: Pharmalittle: German regulator eyes Ozempic export ban amid shortages; NIH-funded clinical trials lagging pharma’s in enrollment

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.

Diabetes

Diabetes Labelling

Recce Pharmaceuticals reports positive phase 2 data for skin infection drug

Pharmafile

FEBRUARY 17, 2025

Recce Pharmaceuticals have announced positive patient data from its phase 2 clinical trial into RECCE 327 (R327), for the treatment of acute bacterial skin and skin structure infections (ABSSSIs), including diabetic foot infections (DFI).

Diabetes

Diabetes Labelling

Roche's Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study

World Pharma News

OCTOBER 18, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.(4)

Diabetes

Diabetes Labelling

Race for approval of first oral GLP-1R drug in obesity intensifies with four in phase III trials: GlobalData

Express Pharma

DECEMBER 2, 2024

The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. Novo Nordisk is leading the pack with four separate products, two apiece in Phase III and Phase II.

Labelling

Labelling Diabetes Drug Development

STAT+: Pharmalittle: Patients brace for insurance decisions on weight loss drugs; Indian authorities find multiple problems at pharma plants

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.

Labelling

Labelling Diabetes

STAT+: Pharmalittle: We’re reading about Bavarian Nordic’s mpox shot, a crackdown on Ozempic prescribing and more

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.

Medical Records

Medical Records Labelling Diabetes Drug Pricing

Provention faces delay in FDA review of diabetes prevention antibody

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.

Diabetes

Diabetes Labelling

FDA Approves Label Update for Semaglutide, Allowing Use as First-Line Option for Adults with Type 2 Diabetes

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.

Labelling

Labelling Diabetes

Better Therapeutics begins ‘real world’ study of digital diabetes therapy

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.

Diabetes

Diabetes Labelling

FDA expands label for Roche's eye disease implant Susvimo

pharmaphorum

FEBRUARY 5, 2025

The renaissance of Roche's refillable ophthalmic implant Susvimo has continued with FDA approval for use in patients with diabetic macular oedema

Labelling

Labelling Diabetes

Novo Nordisk plans label expansion for Rybelsus following Phase III win

Pharmaceutical Technology

OCTOBER 22, 2024

The oral semaglutide reduced the occurrence of major adverse cardiovascular events (MACE) by 14% in patients with type 2 diabetes.

Labelling

Labelling Diabetes

Off-label Use

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.

Labelling

Labelling Dosage Immunity Immunization

New CKD treatment option approved in EU

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.

Diabetes

Diabetes Labelling Hospitals

Ozempic compensating for Wegovy’s supply shortage due to high demand

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.

Diabetes

Diabetes Labelling

Smartphone-powered trial backs J&J’s Invokana for heart failure

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.

Diabetes

Diabetes Labelling

MHRA finds fake Ozempic pens in UK supply chain

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.

Labelling

Labelling Diabetes

Innovative biologic prefilled syringe approved in EU

European Pharmaceutical Review

DECEMBER 13, 2024

This authorises a novel CE-labelled needle for intravitreal injection. Vabysmo 6.0mg is indicated for treating neovascular or wet age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO). Wykoff et al. ).

Diabetes

Diabetes Labelling Hospitals

Bayer looks to expand Kerendia label to include heart failure

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.

Labelling

Labelling Diabetes

Roche’s Vabysmo showcases stronghold across wAMD and DME spaces : GlobalData

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.

Diabetes

Diabetes Labelling

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA

pharmaphorum

MAY 4, 2021

Farxiga – known as Forxiga in some markets – is the first in the SGLT2 inhibitor class to get a CKD indication on its US label, opening up a sizeable new indication for the drug. There are around 37 million people in the US alone with CKD.

Diabetes

Diabetes Labelling

Stage set for Jardiance to become universal heart failure drug

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.

Labelling

Labelling Diabetes Hospitals

Viking’s weight loss drug enters an already crowded arena

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,

Diabetes

Diabetes Dosage Labelling

Mixing Branded and Unbranded on One Page—Is it Worth the Risk?

Pharma Marketing Network

OCTOBER 22, 2020

Accordingly, if a company is promoting a drug for catatonic schizophrenia, but the product is only approved for disorganized schizophrenia, such promotion could cause patients and clinicians to believe that the product is approved for an off label disease. For example, a marketer may want to place an ad for an anti-diabetes drug.

Diabetes

Diabetes Labelling

AstraZeneca’s Xigduo XR Receives the NMPA’s Approval for the Treatment of Type-2 Diabetes

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

Diabetes

Diabetes Labelling

Lexicon gets FDA approval for Inpefa to treat heart failure

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.

Labelling

Labelling Diabetes Hospitals

Diabetic macular oedema market expected to grow to $11.1bn globally by 2031

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.

Diabetes

Diabetes Biosimilars Labelling

MAHA, Nutrition, and the FDA

FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

As reported in a recent publication (citations omitted): An estimated 129 million people in the US have at least 1 major chronic disease (eg, heart disease, cancer, diabetes, obesity, hypertension) as defined by the US Department of Health and Human Services. Undoubtedly, the public health and economic toll of chronic disease is staggering.

Labelling

Labelling Diabetes

PPC Campaign Optimization for Pharma: Boosting ROI

Pharma Marketing Network

MARCH 8, 2025

diabetes, cancer). No unapproved drug claims All claims must be backed by clinical research and FDA-approved labeling. No targeting based on sensitive medical conditions (e.g., Landing pages must align with ad content misleading claims can lead to account suspension.

HIPAA

HIPAA Pharmaceutical Companies Pharmaceutical Companies Labelling

Novo Nordisk ups forecasts after Q1 profit boost

pharmaphorum

MAY 5, 2021

The world’s biggest manufacturer of diabetes drugs expects growth in constant currencies at between 6% and 10%, up from the previous forecast in the 5%-9% range. Novo is also working towards a refiling of its label expansion for a new 2mg formulation of once weekly Ozempic (semaglutide) to treat type 2 diabetes.

Diabetes

Diabetes Labelling

Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN.

Diabetes

Diabetes Labelling Immunity Immunization

Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN.

Diabetes

Diabetes Labelling Immunity Immunization

Merck enhances ophthalmology portfolio with EyeBio acquisition

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.

Research Laboratories

Research Laboratories Diabetes Labelling

Chasing rivals, Bayer files Nubeqa for new prostate cancer use

pharmaphorum

MARCH 10, 2022

Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug. The post Chasing rivals, Bayer files Nubeqa for new prostate cancer use appeared first on.

Labelling

Labelling Chemotherapy Diabetes

Bayer triples sales forecast for prostate cancer drug Nubeqa

pharmaphorum

FEBRUARY 18, 2022

The data will be filed with regulatory authorities to seek an expansion of the label for Nubeqa, according to Bayer, which developed Nubeqa in collaboration with Finland’s Orion. There was also a big increase in the duration of response, from a media of just under 17 months to 41 months.

Chemotherapy

Chemotherapy Labelling Diabetes

How the FDA’s new nutrition labels could prod the food industry to get healthier

STAT+: Pharmalittle: Lilly diabetes drug back on shelves after two-month shortage; AbbVie sued for human rights violations over Humira pricing

Trending Sources

Weight loss drugs without a prescription? Study warns it’s a ‘very risky business’

Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression

STAT+: Pharmalittle: We’re reading about fake Ozempic, the FTC policing pharma, and more

STAT+: With weight loss drug ads, telehealth companies wade into a regulatory gray area

STAT+: Pharmalittle: FDA finds ‘potential systemic bias’ in Amgen cancer drug trial; drugmakers organize to push back on antitrust reviews

Counterfeit diabetes pens identified in EU and UK

STAT+: Pharmalittle: We’re reading about Wegovy approved for heart risks, an ALS drug puzzle, and more

STAT+: Pharmalittle: Weight loss drugs cost much more in the U.S.; PBMs win a key victory over an Oklahoma law

STAT+: Pharmalittle: German regulator eyes Ozempic export ban amid shortages; NIH-funded clinical trials lagging pharma’s in enrollment

Recce Pharmaceuticals reports positive phase 2 data for skin infection drug

Roche's Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study

Race for approval of first oral GLP-1R drug in obesity intensifies with four in phase III trials: GlobalData

STAT+: Pharmalittle: Patients brace for insurance decisions on weight loss drugs; Indian authorities find multiple problems at pharma plants

STAT+: Pharmalittle: We’re reading about Bavarian Nordic’s mpox shot, a crackdown on Ozempic prescribing and more

Provention faces delay in FDA review of diabetes prevention antibody

FDA Approves Label Update for Semaglutide, Allowing Use as First-Line Option for Adults with Type 2 Diabetes

Better Therapeutics begins ‘real world’ study of digital diabetes therapy

FDA expands label for Roche's eye disease implant Susvimo

Novo Nordisk plans label expansion for Rybelsus following Phase III win

Off-label Use

New CKD treatment option approved in EU

Ozempic compensating for Wegovy’s supply shortage due to high demand

Smartphone-powered trial backs J&J’s Invokana for heart failure

MHRA finds fake Ozempic pens in UK supply chain

Innovative biologic prefilled syringe approved in EU

Bayer looks to expand Kerendia label to include heart failure

Roche’s Vabysmo showcases stronghold across wAMD and DME spaces : GlobalData

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA

Stage set for Jardiance to become universal heart failure drug

Viking’s weight loss drug enters an already crowded arena

Mixing Branded and Unbranded on One Page—Is it Worth the Risk?

AstraZeneca’s Xigduo XR Receives the NMPA’s Approval for the Treatment of Type-2 Diabetes

Lexicon gets FDA approval for Inpefa to treat heart failure

Diabetic macular oedema market expected to grow to $11.1bn globally by 2031

MAHA, Nutrition, and the FDA

PPC Campaign Optimization for Pharma: Boosting ROI

Novo Nordisk ups forecasts after Q1 profit boost

Developing a new treatment paradigm for chronic kidney disease

Developing a new treatment paradigm for IgAN

Merck enhances ophthalmology portfolio with EyeBio acquisition

Chasing rivals, Bayer files Nubeqa for new prostate cancer use

Bayer triples sales forecast for prostate cancer drug Nubeqa

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