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 105

Labelling 105

Pharmacy Times

NOVEMBER 14, 2024

The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.

Labelling 55

Labelling 55

Pharmaceutical Business Review

JULY 11, 2023

The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Among the other updates to the label include the removal of the Limitations of Use statement. Leqvio was initially approved by the FDA in December 2021.

Labelling 75

Labelling 75

Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

Specialty Pharmacies 94

Specialty Pharmacies Drug Pricing Labelling 94

Express Pharma

JANUARY 29, 2025

The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney disease and major cardiac events by 24 per cent, the company said. Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the label of Ozempic.

Diabetes 76

Diabetes Labelling 76

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 250

Medical Records Labelling Diabetes Drug Pricing 250

Pharmaceutical Technology

MARCH 11, 2024

Wegovy can now be used to reduce the risk of major cardiovascular events in obese or overweight patients with heart disease.

Labelling 52

Labelling 52

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

LifeProNow

JANUARY 18, 2025

At data cutoff in May 2024, safety and tolerability data presented at ESMO demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (TRAEs) (9 percent); five patients had TRAEs leading to discontinuation (6 percent) and no treatment-related deaths were reported.

Packaging 100

Packaging Labelling 100

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

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

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 .

Labelling 128

Labelling Communication Drug Development 128

Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. In an overview, the event comprised a business programme packed with sessions, roundtables and panel discussions.

Packaging 105

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

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%

Labelling 98

Labelling 98

Pharmacy Times

MARCH 4, 2025

The FDA is issuing new changes to labels on testosterone products, clarifying that there are no increases in major cardiac events among men with hypogonadism but noting an increase in blood pressure with the use of such products.

Labelling 32

Labelling 32

Express Pharma

MAY 17, 2024

Longer-term biomarker and efficacy data from the open-label-extension were similar to those seen during the 6-month placebo-controlled treatment period, with sustained reductions in ATXN2 but no impact on NfL or clinical outcome measures over 40+ weeks of follow up. AEs leading to study discontinuation were higher in the BIIB105 group (8.3

Labelling 97

Labelling 97

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 Pharmacy Technician Labelling Medical Records 52

Express Pharma

MAY 5, 2024

1 The most common treatment-related emergent adverse events (TEAEs) were Grade 1/2 lower urinary tract events. In C3, 31 patients were efficacy evaluable with 28/31 achieving a complete response (CR) rate of 90 per cent (95 per cent CI, 74-98). There were no dose-limiting toxicities and no deaths.

Labelling 104

Labelling 104

LifeProNow

MARCH 8, 2024

No illnesses or adverse events have been reported to date related to the ground cinnamon products listed below, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe. Consumers can find lot codes listed on the product’s label.

Labelling 130

Labelling 130

FDA Law Blog: Biosimilars

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.

Labelling 40

Labelling Vaccines Communication 40

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 *.

Labelling 98

Labelling 98

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

Adverse Reactions 111

Adverse Reactions Labelling 111

Express Pharma

AUGUST 6, 2024

FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicenter, event-driven Phase III trial to assess the efficacy and safety of finerenone on top of standard therapies in patients with a mildly reduced or preserved left ventricular ejection fraction of 40 per cent or greater.

Dosage 104

Dosage Labelling 104

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 Diabetes Hospitals 98

Express Pharma

FEBRUARY 10, 2025

The approvals are based on safety and efficacy data from the ROCKstar trial, a randomised, open-label, multicentre pivotal study evaluating Rezurock in patients with cGVHD who had received two to five prior lines of systemic therapy. Rezurock is administered orally once daily at a 200 mg dose.

Labelling 52

Labelling 52

Express Pharma

MARCH 20, 2024

Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy’s Laboratories (Moderator) + Chandi Prasad Ravipati, Head-Packaging Development, Aurobindo Pharma + Santanu Chowdhury, Sr GM – Packaging Development, Sun Pharmaceutical Industries + Prabir Das, Pharma Expert + Dr Sajeev Chandran, VP – Pharma R&D, (..)

Packaging 52

Packaging Labelling 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

Biosimilars 98

Biosimilars Dosage Labelling 98

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.

Chemotherapy 122

Chemotherapy Labelling Compounding 122

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).

Labelling 105

Labelling Immunity Immunization Vaccines 105

European Pharmaceutical Review

SEPTEMBER 22, 2022

The Phase I/II trial ( NCT05144386 ), sponsored by Excision, is an open-label, sequential cohort, single ascending dose study and will enrol nine patients. As a result, HIV can persist in tissue reservoirs for years.

Labelling 145

Labelling Immunity Immunization 145

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.

Documentation 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

Pharma Marketing Network

MARCH 23, 2021

Get your complimentary copy of "The Publishing Industry: The Soar of Innovation During COVID-19 Fact Sheet". Company Email *.

Labelling 72

Labelling 72

Eye on FDA

JUNE 14, 2023

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). It was the second letter for this company, the first having been issued in August, 2020 for a TV advertisement.

Labelling 82

Labelling Communication 82

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

FDA Law Blog: Biosimilars

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.

Labelling 59

Labelling 59

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.

Labelling 98

Labelling Pharmaceutical Companies Pharmaceutical Companies 98