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 272

Labelling Documentation Diabetes 272

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 105

Diabetes Labelling 105

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 266

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 245

Diabetes Labelling 245

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 59

Diabetes Labelling 59

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 95

Diabetes Labelling 95

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 126

Labelling Diabetes Drug Development 126

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 240

Labelling Diabetes 240

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 263

Medical Records Labelling Diabetes Drug Pricing 263

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 98

Diabetes Labelling 98

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 49

Labelling Diabetes 49

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 72

Diabetes Labelling 72

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 68

Labelling Diabetes 68

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 64

Labelling Diabetes 64

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 40

Labelling Dosage Immunity Immunization 40

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 98

Diabetes Labelling Hospitals 98

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 111

Diabetes Labelling 111

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 105

Diabetes Labelling 105

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 130

Labelling Diabetes 130

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 97

Diabetes Labelling Hospitals 97

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 52

Labelling Diabetes 52

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 105

Diabetes Labelling 105

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 98

Diabetes Labelling 98

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 98

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,

Diabetes 105

Diabetes Dosage Labelling 105

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 104

Diabetes Labelling 104

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 40

Diabetes Labelling 40

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 98

Labelling Diabetes 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.

Diabetes 52

Diabetes Biosimilars Labelling 52

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 64

Labelling Diabetes 64

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 59

HIPAA Pharmaceutical Companies Pharmaceutical Companies Labelling 59

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 72

Diabetes Labelling 72

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 98

Diabetes Labelling Immunity Immunization 98

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 98

Diabetes Labelling Immunity Immunization 98

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 59

Research Laboratories Diabetes Labelling 59

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 81

Labelling Chemotherapy Diabetes 81

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 98

Chemotherapy Labelling Diabetes 98