pharmaphorum

SEPTEMBER 10, 2021

Some insurers have refused to cover the drug, citing what they claim is unproven efficacy for the anti-amyloid drug, as well as the risk of adverse events, while the FDA has also come under fire over its handling of the review and approval. The post Biogen admits slow Aduhelm launch, as scientists question label again appeared first on.

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Labelling Insurance FDA 87

pharmaphorum

DECEMBER 1, 2023

The STABILIZE-CKD and DIALIZE-Outcomes studies – part of AZ’s CRYSTALIZE programme for the drug – have been shelved because patients were being enrolled into them more slowly than hoped for, and clinical events were occurring at a lower rate than expected.

Labelling 101

Labelling 101

BuzzRx

JANUARY 27, 2023

The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.

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Labelling FDA Dosage Pharmaceutical Companies 52

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.

Labelling 50

Labelling FDA 50

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.

Labelling 59

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 FDA Law Blog

SEPTEMBER 23, 2022

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.

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Labelling Adverse Reactions FDA 52

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?

Hospitals 52

Hospitals Labelling Medical Records Documentation 52

STAT

AUGUST 20, 2024

Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted. 

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FDA Communication Labelling Insurance 132

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.

Labelling 40

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 82

The Checkup by Singlecare

OCTOBER 10, 2024

American headlines are loaded with news on Ozempic (semaglutide), the Type 2 diabetes drug popularly used off-label for weight loss. Similar findings were noted in a study on its use for weight management (an off-label use) in those who were overweight or had obesity. The FDA warns about that risk on the drug label.

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Labelling FDA 52

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 57

STAT

AUGUST 30, 2024

… Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment , STAT writes. of those who received placebo.

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Hospitals Labelling 108

The FDA Law Blog

JULY 7, 2024

Timeliness is critical not only for developing appropriate corrective actions but also for evaluating and, when necessary, submitting reportable events to FDA as discussed below. establish and maintain adverse event files.” [9] establish and maintain adverse event files.” [9] report certain device malfunctions, and.

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Labelling FDA Communication Documentation 62

The Checkup by Singlecare

AUGUST 14, 2024

Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use.

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Labelling FDA Insurance Insurance Coverage 52

European Pharmaceutical Review

JANUARY 25, 2023

Participants were enrolled into an open-label phase of the study, which enabled the assessment of durability of antidepressant effect, as well as the comparative efficacy and safety of a one versus two dose regimen of SPL026. No drug-related serious adverse events (SAEs) reported, including no reported suicidal ideation or behaviour.

Labelling 133

Labelling 133

The Checkup by Singlecare

NOVEMBER 5, 2024

Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors. Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors.

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Labelling Insurance FDA Dosage 52

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 98

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

European Pharmaceutical Review

SEPTEMBER 10, 2024

The injectable treatment was assessed against placebo in the SWIFT-1 and SWIFT-2 trials and open label extension study (AGILE). GSK noted that rates of patients experiencing adverse events was similar in both the depemokimab and placebo groups in the Phase III trials.

Labelling 59

Labelling 59

STAT

JULY 26, 2024

Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year. Novo plans to add the prescribing information on the Wegovy label in the EU within about one month. regulator, while the U.S. Continue to STAT+ to read the full story…

Labelling 109

Labelling 109

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.

Labelling 52

Labelling Hospitals 52

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

The FDA Law Blog

JULY 22, 2024

Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” s John W.M. s John W.M. You can register for the conference here. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

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Packaging Labelling FDA 57

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

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 96

STAT

SEPTEMBER 13, 2024

We plan to catch up on sundry tasks, promenade with the official mascots and escort Mrs. Pharmalot to an event or two. One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. And what about you?

Medical Records 99

Medical Records Insurance Labelling FDA 99

The Checkup by Singlecare

JULY 3, 2024

Ozempic for cardiovascular disease “In people with Type 2 diabetes and established cardiovascular disease , Ozempic has been shown to reduce the risk of major cardiovascular events like heart attack, stroke, and cardiovascular-related death,” Dr. Lightning said.

Labelling 69

Labelling Insurance FDA 69

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 128

European Pharmaceutical Review

NOVEMBER 21, 2022

The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0

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Adverse Reactions Labelling 111

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.

Labelling 98

Labelling Hospitals 98

Hospital Pharmacy Europe

JULY 18, 2023

Removing the label of being allergic to penicillin involves intra-dermal skin testing followed by an oral penicillin challenge. In the five days following the oral penicillin challenge, a total of nine immune-mediated adverse events were recorded in the intervention group and 10 in the control group.

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Immunization Labelling Hospitals 98

OctariusRx

MAY 13, 2024

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

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. MBK-01 demonstrated a greater clinical benefit than fidaxomicin when used as the first choice for treatment of the current CDI episode event without any antibiotic treatment. percent compared to 61.54

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Documentation Labelling Hospitals 111

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