European Pharmaceutical Review

JANUARY 23, 2023

This has been exacerbated by geopolitical events such as war, the energy crisis and high inflation rates. MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern.

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Packaging Compounding Communication Labelling 98

IDStewardship

JUNE 6, 2023

Streamlined Prescription Filling : AI systems can automate prescription filling processes by extracting relevant information from electronic prescriptions, verifying insurance coverage, and generating labels. AI can assist in language translation, improving communication with non-native speakers.

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The Checkup by Singlecare

FEBRUARY 17, 2025

Some risks of using compounded semaglutide include: Unknown side effects Wrong doses Contamination Risk of drug interactions Mistakes in labeling Allergenic or expired ingredients Its best to talk to a healthcare provider before trying compounded semaglutide. Ask about potential adverse events and how to manage them.

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Compounding Compounding Pharmacies FDA Dosage 52

pharmaphorum

OCTOBER 31, 2022

Our approach is to create a strawman schematic of the required model design based on the disease and therapeutic structure, along with a future event audit. Apply a trending and event-based forecast methodology. Then, use events to model how the market will change in the future if, for example, a new product comes to market.

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Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

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Labelling Insurance Communication FDA 105

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

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Labelling Insurance Communication FDA 98

Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. Cytokine release syndrome and neurotoxicity were reported to be the most prevalent adverse events (AEs) linked to CNCT19. In the trial, 82.1%

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ISPE

JULY 19, 2023

The framework conditions for this VUCA world have become more acute: Pandemics and geopolitical events are causing fragile and complex supply chains to collapse. and management communication strategy. Conclusion The combined conference event brought discussion of these key Pharma 4.0™

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Documentation FDA Communication Labelling 98

pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation.

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FDA Documentation Communication Labelling 105

Pharmaceutical Technology

SEPTEMBER 23, 2022

Additionally , loss of hearing at a young age is associated with impaired communication, cognitive impairment, poorer mental health and quality of life. These open-label, randomized clinical trials were done in patients under 18 years of age. Pedmark clinical trials. The therapeutic landscape.

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FDA Communication Chemotherapy Labelling 52

Hospital Pharmacy Europe

DECEMBER 18, 2023

There are often difficulties with adherence from multiple causes including communication difficulties, dysphagia, polypharmacy and adverse drug events. 15,16 A comprehensive assessment of potential DDIs is strongly recommended, particularly at the start of anticancer treatment. Lancet Healthy Longev 2022;3:e617–e627 Mohamed MR et al.

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Chemotherapy Hospitals Communication Labelling 96

Pharmaceutical Technology

JANUARY 15, 2023

Using the manufacturing contract-related data collated from PharmSource reports, and news from the GlobalData Pharma Intelligence Center, Pharmaceutical Technology has collated some of the key regulatory events from late November to late December that will likely impact manufacturing volumes, and stakeholders that will likely be affected.

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Labelling Packaging FDA Communication 52

The Checkup by Singlecare

MARCH 7, 2024

If someone sustains side effects (such as cardiac issues or neurological problems) from excessive doses of Adderall, those would be considered adverse events, not side effects,” Dr. Martinez says. The Adderall drug label shows no reports of adverse effects in a breastfeeding infant, but long-term effects are unknown.

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Dosage FDA Communication Labelling 104

The Checkup by Singlecare

OCTOBER 16, 2023

What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Migraine Headaches Another off-label use of Cymbalta is for the management of migraine headaches. The medication may help strengthen the muscles that control urine flow and improve overall bladder function.

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Dosage Insurance Coverage Labelling Insurance 52

The Checkup by Singlecare

MAY 4, 2023

Adding notes about the shape, size, and texture of their pills to the medication list can help in the event pills do get mixed up. Understanding the drug label Much of the information you need to know is printed on the label of your medicine. OTC meds usually have a “Drug Facts” label that lists important information.

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Health and Personal Care Stores Labelling Dosage Compounding Pharmacies 52

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. Special thanks to Ms. LTD Glace Life Technology (Shanghai) Co.,

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Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. Special thanks to Ms. LTD Glace Life Technology (Shanghai) Co.,

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

Hospital Pharmacy Europe

FEBRUARY 22, 2024

As such, individuals with these genetic variants are at increased risk of adverse cardiac and cerebrovascular events if treated with clopidogrel. As such, individuals with these genetic variants are at increased risk of adverse cardiac and cerebrovascular events if treated with clopidogrel. Introduction to pharmacogenetics.

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Hospitals Patient Care Medical Records Dosage 111

The Checkup by Singlecare

JANUARY 6, 2025

Because it suppresses the central nervous systems fight or flight hormones, propranolol is sometimes prescribed off-label for anxiety, especially performance anxiety , social anxiety , panic attacks , and situational anxiety, such as fear of flying. Of course, people on propranolol to treat anxiety might wonder when and how to stop taking it.

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Dosage Communication Labelling FDA 59

The Honest Apothecary

AUGUST 12, 2022

lt means that acknowledging a special event in someone’s life (a birthday, marriage, accomplishment) is more important than submitting my end of month financial paperwork on time. But it tends to communicate that you don’t trust your manager if you are regularly meeting with his/her direct reports with an agenda of your own.

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Communication Labelling 52

The FDA Law Blog

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). FDA also recommends the implant ID card provide contact information in the event of malfunctions or adverse events.

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The FDA Law Blog

SEPTEMBER 22, 2024

After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. This callout is notable as FDA recently issued its first Warning Letter citing a manufacturer for failing to save these electronic acknowledgements in MDR event files.

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FDA Communication Labelling 64

Roots Analysis

DECEMBER 10, 2023

Philips responded by updating instructions and labeling for all affected CPAP and BiPAP machine masks, explicitly warning about possible magnetic interference and listing metallic implants as contraindications. Users with metallic implants are advised to consult their healthcare providers and switch to non-magnetic masks.

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FDA Communication Labelling 45

Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. It showed promising event-free survival (EFS) of 62.4%

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Chemotherapy Labelling FDA Communication 52

Pharmaceutical Technology

JUNE 1, 2023

After this, patients receiving a placebo were switched to the frexalimab arm and entered the ongoing open-label part B portion of the study. Researchers observed an 89% and 79% reduction in new gadolinium-enhancing (GdE) T1-lesions for higher and lower doses, respectively, compared to placebo.

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Pharmaceutical Technology

MAY 30, 2023

The safety data was consistent with the previous updates, with the majority of adverse events (AEs) being grade 1 and 2, with no grade 4 AEs reported. The data is exploratory and the company has not yet announced any plans to expand Orsedu’s label. months, versus 1.87 months on standard of care (SOC) (HR 0.518; 95% CI: 0.216-1.165).

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Communication Labelling FDA 59

Pharmaceutical Technology

MAY 23, 2023

In February, Centessa presented additional data from the Phase IIa Serpin PC study (NCT04073498) at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), showing that there were no treatment-related adverse events observed. Please check your email to download the Report.

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FDA Communication Labelling 59

The Checkup by Singlecare

DECEMBER 6, 2023

Many drug interactions between metronidazole and other medications occur because of increased side effects of one of the medications, either metronidazole or the other drug In the event of a metronidazole interaction, promptly seek medical advice. Check food labels for inclusion of propylene glycol while on a course of metronidazole.

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Dosage Communication Labelling Hospitals 52

Pharma Marketing Network

JUNE 11, 2020

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. So whether you’re an advertiser or an event coordinator or a supplier in the industry, most of them have pretty active blogs. We want to be a resource for them. I mean, everybody is a publisher.

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Pharmaceutical Companies Pharmaceutical Companies Communication Labelling 52

pharmaphorum

OCTOBER 7, 2021

If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. Rewind to March of 2020, and pharma companies were facing a communication crisis. The crisis that changed everything.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 75

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.

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Labelling Vaccines Communication 105

The FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] establish and maintain adverse event files.” [9]

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Labelling FDA Communication Documentation 64

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. The mindset that accomplished this needs to be retained,” Jeremy says. About the interviewees.

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The Checkup by Singlecare

OCTOBER 22, 2024

You’ve probably heard the buzz about Ozempic (active ingredient semaglutide), a popular brand name, FDA-approved Type 2 diabetes medication that’s also used off-label for weight loss. By maintaining open communication with your healthcare provider and making necessary lifestyle adjustments, you can stop taking Ozempic safely.

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Communication Labelling FDA 105

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 Checkup by Singlecare

MARCH 8, 2024

It is also used off-label for other forms of anxiety, like agoraphobia, panic disorders, and acute vertigo episodes. An FDA drug safety communication described that combining opioids with benzodiazepines like alprazolam has resulted in serious adverse events related to the additive CNS depression contributed by both types of medication.

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