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 289

Medical Records Labelling Diabetes Drug Pricing 289

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

FDA Law Blog: Biosimilars

JUNE 2, 2025

Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision.

Labelling 59

Labelling 59

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

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling 98

Labelling Communication 98

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 98

Specialty Pharmacies Drug Pricing Labelling 98

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

Express Pharma

MARCH 12, 2025

The Indian Pharmaceutical Alliance (IPA) questions the reliance on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) in the Ohio State University report titled, Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events.

Generic Medicine 66

Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 66

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

Express Pharma

APRIL 14, 2025

Telitacicept was also shown to be well-tolerated, with an overall adverse event (AE) incidence like that of the placebo group and an incidence of infection-related AEs that was lower than that of the placebo group. Furthermore, there are also highly effective treatments for MuSK+ patients that are currently used off-label.

Biosimilars 95

Biosimilars Labelling 95

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 Immunization Immunity 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

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 35

Labelling 35

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

Express Pharma

APRIL 12, 2025

Therefore, workplaces must discourage gender biases and reward employees based on individual merit [3] Women bring instinctive creativity, empathy and emotional intelligence to their work and office place [4] Women shouldn’t let labels define them.

Packaging 66

Packaging Labelling 66

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

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

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

pharmaphorum

MAY 10, 2021

At the moment, there’s no indication that the cases are linked to the vaccine itself, but the EMA has asked the companies to provide “further detailed data, including an analysis of the events according to age and gender,” as it looks into the signal.

Vaccines 122

Vaccines Labelling Immunization Immunity 122

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

Express Pharma

JULY 31, 2024

However, pipeline candidates entering the market will also have to compete against Wegovy, which has been pursuing label extensions in various regions. In fact, Wegovy has just been approved in the UK and the EU as the first drug to reduce the risk of cardiovascular events in adults with obesity. “It

Labelling 98

Labelling 98

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

PharmaShots

APRIL 5, 2023

in bevacizumab with no incidence of treatment-induced neutralizing anti-drug Ab MB02 is a bevacizumab biosimilar that has received approval from the US FDA & EMA which previously showed bioequivalence to reference bevacizumab in 3 PK studies in healthy patients Related Post: Insights+ Key Biosimilars Events of February 2023

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

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 Immunization Immunity 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

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

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

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

Documentation 111

Documentation Labelling Hospitals 111

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

Express Pharma

AUGUST 4, 2024

To register or view the event programme click here. DIA is celebrating 60 years of bringing together leading minds to foster collaboration and advancement in global healthcare. Early-bird registration for the India Annual Meeting is available through August 10, 2024.

Generic Medicine 105

Generic Medicine Labelling 105