Pharma Marketing Network

APRIL 28, 2021

With our growing audience of pharma and healthcare professionals, the Pharma Marketing Network (PMN) leverages its experience in helping drive registrations for top-rated events and conferences that attracts diverse populations at scale. Let’s work together to identify the unique needs of your event and produce maximum engagement.

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Labelling 59

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Labelling FDA Vaccines Communication 40

The Happy PharmD

OCTOBER 26, 2022

All events that jeopardized a patient’s safety, such as those involving falls, wrong surgical sites, clinical alarm mishaps, and other safety-related problems could result in a sentinel event. They were called sentinel events because of the immediate need for attention to address these errors. Every case was a sentinel event?

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Hospitals Labelling Medical Records Documentation 52

PharmaShots

APRIL 20, 2023

was associated with fewer confirmed disability worsening events vs those who switched later from teriflunomide to Kesimpta ~80% remained free of 6mos. Shots: The (ALITHIOS) OLE study evaluating Kesimpta which showed continuous treatment with Kesimpta for ~5yr. CDW, low brain volume change over 5yr. vs switch group (-0.42%/yr.) vs -0.28%/yr.

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Labelling 40

STAT

MAY 16, 2023

In any event, the to-do list is growing so we are passing along the latest laundry list of interesting items for you to peruse. So we will celebrate our good fortune with a delightful cup of stimulation. Our choice today is toasted hazelnut. As always, you are invited to join us, or grab a water bottle if you prefer.

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Labelling 97

The FDA Law Blog

NOVEMBER 13, 2023

Designed for in-house legal and compliance counsel, industry executives, and private practice attorneys working for the OTC drug industry, the event will welcome distinguished industry thought leaders – including from the National Advertising Division and FDA – to share their expertise and strategic insights. Director Deborah L.

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Labelling FDA 59

European Pharmaceutical Review

MARCH 6, 2024

Keren Haruvi, President Sandoz North America highlighted that denosumab is a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events. The approval is also accompanied by labelling with safety warnings. Wyost Similarly, Wyost 120 mg/1.7

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FDA Dosage Labelling 91

Hospital Pharmacy Europe

MAY 2, 2024

The cystic fibrosis (CF) medication ivacaftor (brand name Kalydeco) is safe and effective in infants aged four weeks and over, paving the way for earlier initiation of therapy for newborns diagnosed with the condition, a phase 3 open-label study has found. Seven infants with mean age at baseline of 1.9

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Labelling Hospitals 52

The Checkup by Singlecare

FEBRUARY 19, 2024

The drug label for Ozempic specifically states it can be used to help reduce the risk of cardiovascular events like heart attacks and stroke in people with Type 2 diabetes and heart disease. This indication is not found on the label for Rybelsus. They’re generally not covered for off-label purposes like weight management.

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Dosage Insurance Coverage Labelling Insurance 96

pharmaphorum

MARCH 12, 2021

The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety.

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Vaccines Labelling Immunization 145

Pharmaceutical Technology

JULY 27, 2022

The application for the drug comprised data from a Phase I clinical trial in healthy subjects, a Phase I/II trial analysing ascending dose levels, the Phase III VALOR trial and an open-label extension (OLE) trial. It also included the latest one-year combined data from VALOR and the OLE study. Furthermore, 6.7%

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FDA Labelling 98

Hospital Pharmacy Europe

AUGUST 10, 2023

Semaglutide has been found to reduce the risk of major adverse cardiovascular events (MACE) by 20% in overweight or obese adults, its manufacturer Novo Nordisk has claimed. mg reduces the risk of cardiovascular events.‘ Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4

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Labelling Hospitals 98

Hospital Pharmacy Europe

JUNE 2, 2023

Ropinirole use in amyotrophic lateral sclerosis (ALS) significantly delays the time to the first disease progression, according to a recent, but small, randomised placebo-controlled trial with an open-label extension phase. For the study, a number of parameters were assessed with the primary outcome based on adverse events.

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Labelling Hospitals 52

STAT

OCTOBER 25, 2022

Food and Drug Administration regulate drugs, including approved uses and claims made by ads and product labels. Meanwhile, states regulate the actual prescribing events — providers, pharmacies, and medical practice standards. Federal agencies like the U.S. Continue to STAT+ to read the full story…

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Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 98

Hospital Pharmacy Europe

JANUARY 11, 2024

Sustained improvements in Parkinson’s symptoms The launch was supported by three studies, including the Phase 3, 12-month open-label M15-741 study in which the primary endpoint was to evaluate the safety and tolerability of foslevodopa-foscarbidopa.

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Labelling Hospitals 99

pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. . Project Patient Voice .

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Labelling Communication FDA 125

The Checkup by Singlecare

MAY 5, 2024

Off-label uses of both drugs include narcolepsy and severe depression. However, Focalin may also be prescribed off-label for obesity. Condition Focalin Vyvanse ADHD Yes Yes Binge eating disorder No Yes Depression Off-label Off-label Narcolepsy Off-label Off-label Obesity Off-label No Is Focalin or Vyvanse more effective?

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Controlled Substances Labelling Insurance Dosage 52

pharmaphorum

MARCH 3, 2022

The results of the EMPULSE trial showed that adults hospitalised for acute heart failure were 36% more likely to see an improvement on clinical measures – including all-cause mortality, frequency of heart failure events, time to first heart failure event, and symptoms – in the first 90 days after treatment started compared to placebo.

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Labelling Hospitals 98

European Pharmaceutical Review

AUGUST 8, 2023

Headline results from Novo Nordisk’s “landmark” SELECT trial in cardiovascular outcomes has demonstrated a 20 percent reduction in major adverse cardiovascular events (MACEs) for semaglutide 2.4mg (Wegovy ® ) compared to a placebo. Currently, Wegovy is launched in Denmark, Norway, Germany as well as the US.

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Labelling 97

European Pharmaceutical Review

SEPTEMBER 5, 2023

Evidence of efficacy for Wegovy In headline data from its landmark trial evaluating cardiovascular outcomes in obese patients released last month, Novo Nordisk announced that semaglutide 2.4mg (Wegovy) demonstrated a 20 percent reduction in major adverse cardiovascular events.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 89

Pharma Marketing Network

APRIL 15, 2021

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.

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Labelling 98

PQA

FEBRUARY 24, 2023

We also highlight our members' perspectives on oral oncolytics, patient-centered prescription labels and food as medicine. Current medication labels often hinder safe and appropriate use of medicines. PQA SAMs are members-only events. Learn more about this scholarship and other opportunities for students below.

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Labelling Medication Labelling Hospitals 52

Pharmaceutical Technology

DECEMBER 11, 2022

of patients discontinued treatment due to adverse events. The most common Grade ≥3 treatment-related adverse events were neutropenia at 20%, hypertension at 3%, and hemorrhage. The mOS was 13.1 months, which in a historical context, is an improvement in the natural disease course of these patients.

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Labelling FDA 59

The Checkup by Singlecare

JANUARY 26, 2024

Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity. Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects. It received FDA approval for weight management in June 2021.)

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Labelling FDA 111

The Checkup by Singlecare

OCTOBER 4, 2023

In fact, the official FDA guidance about Vyvanse specifically warns against off-label use (a use that is not approved by the FDA) for weight loss, stating, “Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events.

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Labelling FDA Controlled Substances Hospitals 125

The Checkup by Singlecare

FEBRUARY 8, 2024

You certainly don’t want to be at risk of hemorrhaging from too much platelet inhibition, but you also want clopidogrel to be able to do its thing by helping to prevent cardiovascular events. These grave events could include acute coronary syndromes, unstable angina, and myocardial infarctions.

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Labelling FDA 98

Pharmaceutical Technology

JULY 29, 2022

The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients. Furthermore, a 91% and 100% cystectomy avoidance rate and bladder cancer overall survival, respectively, were observed at 24 months without any serious adverse events (SAE).

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FDA Labelling Immunization Vaccines 105

Pharmaceutical Technology

MAY 19, 2023

Satsuma Pharmaceuticals stated that its product candidate showed fast high DHE plasma concentrations, believed to be necessary for efficacy and to be below those DHE plasma levels associated with adverse events, including vomiting and nausea.

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FDA Labelling 59

The Checkup by Singlecare

APRIL 12, 2024

Introduction to Ozempic Ozempic (semaglutide) is a once-weekly prescription medication that is approved by the Food and Drug Administration (FDA) to help lower blood sugar in adults with Type 2 diabetes and lower their risk of cardiovascular events. But Ozempic has gone viral due to one of its side effects: weight loss.

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Pharmacy Program Director Labelling FDA Hospitals 105

Pharmaceutical Technology

OCTOBER 1, 2022

The study also had a randomised, placebo-controlled phase of six months as well as an open-label extension (OLE) long-term follow-up phase. Diarrhoea, nausea, upper respiratory tract infection and abdominal pain were reported to be the most common adverse events linked to Relyvrio.

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FDA Dosage Labelling 97

PharmaShots

JUNE 8, 2023

open-label extension The 1EPs of the trial is the change in proteinuria as evaluated by UPCR @36wk. along with time from randomization to the first occurrence of composite kidney failure endpoint event. Shots: The company initiates the P-III trial of atacicept (150mg, qw, SC) vs PBO in a ratio (1:1) in 376 patients for 104wks.,

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Labelling 40

OctariusRx

MAY 15, 2023

The National Coordinating Council for Medication Error Reporting and Prevention defines medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Need help making the conversion?

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Long-Term Care Facilities Labelling Medication Labelling Documentation 70

European Pharmaceutical Review

AUGUST 17, 2022

The approval of Advanced Accelerator Applications (AAA)’s Pluvicto is based on the alternate primary endpoint results from the randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one AR pathway inhibitor and one or two taxane regimens.

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Chemotherapy Compounding Labelling 113

pharmaphorum

MARCH 15, 2022

The vast majority of societies were able to transition their planned physical events to virtual formats within remarkably short periods of time, and some delivered impressive attendee experiences. Figure 1 What doctors say about virtual events . . And the evolution continues.

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Labelling Vaccines Communication 103

Hospital Pharmacy Europe

SEPTEMBER 28, 2022

In a phase 2 open-label trial, Lifileucel, which is an autologous, centrally manufactured tumour-infiltrating lymphocyte product, demonstrated durable responses, addressing a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy. The median OS for TILT was 25.8 months and 18.9

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Labelling Immunization Hospitals 96

pharmaphorum

MAY 25, 2022

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Identifying the appropriate code and label. The same cannot be said for online events. The codes still apply.

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Documentation Communication Labelling 103

Pharmaceutical Technology

MAY 23, 2023

The open-label, multicentre, active-controlled, randomised Phase III trial was designed for evaluating the safety and efficacy of vadadustat against darbepoetin alfa for the maintenance treatment of anaemia in dialysis-dependent chronic kidney disease (DD-CKD) participants.

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Labelling 52