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

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

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 99

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 99

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 99

Labelling 99

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…

Labelling 246

Labelling Pharmaceutical Companies Pharmaceutical Companies 246

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

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 20

Labelling Diabetes 20

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

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

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 93

Biosimilars Dosage Labelling 93

Pharma Leaders

MAY 3, 2023

The agency decision follows the report of a serious adverse event of pulmonary embolism occurring at the 12 mg twice a day dose in one of the long-term open label extension studies.

Labelling 52

Labelling 52

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

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.

Vaccines 145

Vaccines Labelling Immunity Immunization 145

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 127

Labelling Communication Drug Development 127

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

Big Molecule Watch

AUGUST 24, 2023

CLE credit is only available for our guests attending live webinars and other specified events. The post Biosimilars Webinar Series appeared first on Big Molecule Watch.

Biosimilars 52

Biosimilars Labelling 52

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.

Labelling 98

Labelling Diabetes 98

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 91

Labelling Pharmaceutical Companies Pharmaceutical Companies 91

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

Pharmaceutical Business Review

JANUARY 10, 2024

The M15-741 study, a Phase III 12-month open-label trial, assessed the long-term tolerability, safety, and efficacy of Produodopa. The majority of adverse events (AEs) reported were non-serious and of mild or moderate severity in nature.

Labelling 59

Labelling 59

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.

Labelling 59

Labelling 59

Pharmacy Joe

OCTOBER 22, 2023

The ACORN randomized trial sought to compare rates of AKI and neurotoxicity in patients hospitalized with acute infection who were randomized 1:1 in an open-label fashion to receive either piperacillin-tazobactam or cefepime for gram-negative coverage. However, other studies have examined a link between increased neurotoxicity with cefepime.

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52

Pharmacy Joe

OCTOBER 22, 2023

The ACORN randomized trial sought to compare rates of AKI and neurotoxicity in patients hospitalized with acute infection who were randomized 1:1 in an open-label fashion to receive either piperacillin-tazobactam or cefepime for gram-negative coverage. However, other studies have examined a link between increased neurotoxicity with cefepime.

Hospitals 52

Hospitals Labelling Inpatient 52

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.

Labelling 59

Labelling 59

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

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.,

Labelling 40

Labelling 40

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.

Dosage 97

Dosage Labelling 97

LifeProNow

MARCH 10, 2023

million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. These events can lead to device shortages that significantly impact patient care and jeopardize healthcare worker safety.

Labelling 130

Labelling Packaging Controlled Substances 130

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 116

Chemotherapy Compounding Labelling 116

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

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.

Labelling 52

Labelling 52

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 104

Documentation Communication Pharmaceutical Manufacturing Labelling 104

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.

Labelling 104

Labelling Vaccines Communication 104

Pharma Marketing Network

AUGUST 2, 2021

EHSx can connect your brand with your target audiences on over 4,000 quality whitelist healthcare publishers, and 10,000 pharma-safe, non-endemic properties. Download our EHSX one-pager to learn more!

Labelling 52

Labelling 52

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting.

Communication 68

Communication Packaging Labelling 68

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.

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Vaccines Labelling Immunity Immunization 120