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. 

Labelling 333

Labelling Communication 333

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.

Labelling 87

Labelling Insurance Coverage and Processing 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

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.

Labelling 206

Labelling Drug Development 206

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

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

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.

Hospitals 273

Hospitals Labelling 273

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

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 278

Labelling Diabetes 278

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

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 242

Labelling Pharmaceutical Companies Pharmaceutical Companies 242

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 252

Medical Records Labelling Diabetes Drug Pricing 252

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

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 96

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 96

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 57

Labelling 57

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

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

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 85

Labelling 85

FDA Law Blog: Biosimilars

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.

Labelling 62

Labelling Communication Documentation 62

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

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 95

Dosage Labelling 95

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 91

Labelling 91

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

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

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 92

Labelling 92

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

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

Pharmaceutical Business Review

NOVEMBER 1, 2024

The open-label, single-arm, multi-centre Phase Ib study is designed to evaluate the safety and efficacy of ELA026 in treating sHLH. Furthermore, manageable adverse events were reported in the trial subjects. Recently, the company announced findings from its Phase Ib trial of ELA026.

Labelling 52

Labelling Immunity Immunization 52

FDA Law Blog: Biosimilars

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 ).

Packaging 57

Packaging Labelling 57

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

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. – According to the CDC , adverse drug events cause around 1.3

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Before filling and labeling, you should thoroughly examine the filling line using a standard operating procedure. Please look at the labeling operation in the picture below.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

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

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

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

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 101

Generic Medicine Labelling 101