Pharmacy Times

FEBRUARY 16, 2024

Taking a few seconds to double-check a prescription can have significant impacts on patient safety

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Prescription Medical Safety Patients 57

PM360

FEBRUARY 8, 2024

Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye. It’s open-source design meets FDA requirements for safety and protection.

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Prescription Pharma Engineering Safety 52

World of DTC Marketing

APRIL 12, 2021

We need a 21st-century approach that puts patient safety first. In other words, money over safety. The answer lies in both an outdated way we develop prescription drugs and the continued quest for the next big blockbuster. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary.

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Food and Drug Administration Prescription Pharma Manufacturing 187

World of DTC Marketing

DECEMBER 23, 2020

Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Online research is used to evaluate new prescription drugs. But is this really true across all DTC?

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Pharmaceutical Technology

MAY 2, 2023

The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA). The European Medicines Agency (EMA) has also validated the Type II variation application for Reblozyl.

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Food and Drug Administration FDA Safety Prescription 98

Nixon Gwilt Law

FEBRUARY 27, 2023

If this data isn’t available, the practitioner must limit the prescription to a 7-day supply; Keeps detailed records regarding prescriptions written based on telemedicine encounters. Records can be kept in digital or paper form, and the proposed rule includes specific data points (e.g.,

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Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. Quizartinib had a 11.3%

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Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

JUNE 14, 2023

NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface. Its safety and efficacy have been demonstrated in numerous studies in Europe, the United States and China.

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Food and Drug Administration Pharmaceutical Safety Prescription 52

Clarivate

OCTOBER 28, 2021

That’s why trademark analysts also assess for patient safety. It can be a tricky business, and an important one not just for commercial reasons, but also for patient safety. The brand name chosen for a vaccine or drug is more than a commercial matter. Get the full story. pharmaceuticals require some special considerations.?Ultimately,

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Pharmaceutical Technology

JUNE 19, 2023

The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement. In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology.

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Food and Drug Administration FDA Prescription Food 98

World of DTC Marketing

JUNE 24, 2021

Safety pages on Pharma product websites continue to have high utility. Prescription drugs are not the same as items found in a grocery store. People don’t see an ad for a prescription drug and say, “oh, I need that!” SUMMARY: Consumers don’t real pay attention to fair balance in TV ads.

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European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. It emphasises its ability to make information interoperable with electronic health systems such as e-prescription and electronic health records.

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Healthcare Healthcare Electronics Safety 83

pharmaphorum

NOVEMBER 16, 2022

Novartis completed the spin-out of Alcon in 2019, separating products like contact lenses and over-the-counter eyedrops from its prescription eye medicines, headed by age-related macular degeneration (AMD) blockbuster Lucentis (ranibizumab), which is partnered with Roche. billion in the first nine months of this year.

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Sales Prescription Medicine Media 120

World of DTC Marketing

NOVEMBER 1, 2021

They give us insights like this “dollars are being spent on advertising related to COVID-19, as public health organizations and private medical institutions raised awareness around testing, safety measures, and other pandemic-related information,” which aren’t insights at all.

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Pharmaceutical Technology

MAY 31, 2023

The Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC. Phase I of the trial has a number of primary and secondary safety and pharmacokinetics endpoints. is the primary endpoint of the Phase II study. “We

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Food and Drug Administration FDA Safety Prescription 52

PM360

MAY 25, 2023

The guidance document is short at 19 pages, and by design not prescriptive. It also lays out the agency’s current thinking on informed consent, review board oversight, packaging and shipping of investigational medicines, and factors to consider in a safety monitoring plan. home health visits).

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Pharmaceutical Technology

APRIL 19, 2023

The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. Roflumilast foam had a favourable safety profile and was also found to be well-tolerated. to treat patients aged nine years and above with seborrheic dermatitis.

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Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

MAY 19, 2023

The prescription drug user fee act (PDUFA) date is expected to be set as January 2024. In the long-term, open-label, safety ASCEND trial, 446 participants with more than 9,000 migraine attacks were treated with more than 10,500 STS101 doses for up to 18 months.

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Food and Drug Administration FDA Prescription Food 59

Pharmaceutical Technology

AUGUST 22, 2022

When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. Softgels have now achieved strong recognition in the prescription, consumer health and supplements markets. 200x260/0 (who.int).

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Prescription Safety Patients Pharmaceutical 52

World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

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Food and Drug Administration Government Safety Side effects 203

World of DTC Marketing

FEBRUARY 4, 2021

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. Newly unsealed court documents show that Merck and U.S.

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Pharma Food and Drug Administration Side effects Safety 180

Pharma Leaders

JUNE 21, 2023

It also includes safety data from 50 patients including six patients followed for six or more years. A Prescription Drug User Fee Act (PDUFA) goal date of 20 December this year has been assigned by the agency. It is claimed to be the longest follow-up of any gene therapy programme for SCD.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JUNE 14, 2023

The placebo-controlled, double-blind, randomised trial assessed the efficacy and safety of Bylvay 120µg/kg/day given for 24 weeks to relieve pruritus in patients with ALGS from 32 sites across the Middle East, Europe, North America and the Asia Pacific. The therapy is being offered immediately through prescription for eligible ALGS patients.

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Food and Drug Administration FDA Transportation Prescription 52

pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. million in the third quarter, with predictions that it will make between $14 million and $16 million from its prescription DTx range for the full year. billion.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision. Aldeyra stated that the investigational drug candidate had been studied in over 2,000 patients, and no clinically significant safety concerns were observed.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JULY 25, 2022

An action date for the decision from the regulatory agency or the Prescription Drug User Fee Act date on the therapy is expected in the fourth quarter of this year. Furthermore, Enhertu’s safety profile was in line with prior trials without any new safety concerns reported.

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Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

DECEMBER 22, 2022

Theft, fraudulent prescriptions and unsanctioned distribution by patients and medical practitioners are the most common ways in which legal fentanyl products are illegally secured. Increased trafficking of illegal fentanyl represents a new threat to public health and safety. A lethal drug that creates its own demand.

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PM360

AUGUST 9, 2022

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. The Andaman7 Platform Solution. Vincent Keunen.

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Prescription Medical Side effects Patients 105

European Pharmaceutical Review

DECEMBER 6, 2022

“Through our clinical development programme, we have seen that tofersen has the potential to slow the progression of this relentless and ultimately fatal disease,” commented Priya Singhal, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc.

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Marketing Food and Drug Administration Medicine Prescription 88

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

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Food and Drug Administration Competition Safety Pharmacology 98

World of DTC Marketing

MAY 19, 2021

According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023.

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Pharmaceutical Technology

JULY 14, 2022

Furthermore, this status provides some incentives that may include tax credits for clinical trial costs and prescription drug user fee waivers.

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Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. 1435 (“Affordable Prescriptions for Patients Act of 2021”), [link] gov/bill/117th-congress/senate-bill/1435/text; H.R. Actavis, 570 U.S. 136 (2013), [link] opinions/12pdf/12-416_m5n0.pdf.

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Contrarian Sales Techniques

FEBRUARY 23, 2023

While building and maintaining relationships with key opinion leaders (KOLs) and thought leaders is an essential part of a pharmaceutical sales representative's job, there have been cases where reps have misused their relationship with KOLs to influence prescriptions. No sale is worth risking your health or safety.

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Ethics Pharmaceutical Sales Sales Safety 52

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety.

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Healthcare Healthcare Doctors Physicians 52

Penrod

MARCH 25, 2024

This digitization was not trivial; it curated information in real-time, enabled quick access to data, and improved patient safety through better-informed care decisions. Imagine a healthcare ecosystem where patient scheduling, billing, claims, lab analyses, and prescription fulfillment are in one platform.

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Clarivate

OCTOBER 25, 2023

While more expensive than type 2 diabetes drugs, blood thinners follow a similar pattern of high prescription volumes. In both cases, a shift in formulary placement could lower prescription volumes and reduce member utilization. With 27.5% Providers therefore could find their buy and bill operations are in the red.

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