European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

Food and Drug Administration 80

Food and Drug Administration Manufacturing Management Safety 80

Pharmaceutical Technology

JULY 7, 2022

The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The treatment is indicated for such patients who are at increased risk for disease progression, including hospital admission or mortality. 2 subvariants.

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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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Food and Drug Administration Patients Safety Recruitment 52

Pharmaceutical Technology

SEPTEMBER 28, 2022

In June last year, the US Food and Drug Administration (FDA) granted approval for the antiviral therapy to treat human smallpox disease in adult as well as paediatric patients, including neonates. Chimerix entered a ten-year contract worth up to $680m with the US Government in August this year for delivering up to 1.7

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European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

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Government Pharma Ethics Training 88

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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Pharma Food and Drug Administration Government Medicine 105

World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The government allowed the drugmakers to mass-produce the vaccine while still conducting clinical trials.

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Food and Drug Administration Government Safety Side effects 203

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

Pharmaceutical Technology

MAY 26, 2023

The device received US Food and Drug Administration 510(k) clearance last week for those ages six years and above living with type 1 diabetes. In recent months, Insulin prices reached dizzying heights , forcing the US government to apply cost caps on the treatment.

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Manufacturing Food and Drug Administration Management Government 59

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. Machine Learning in Medicine.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

MARCH 2, 2023

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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Food and Drug Administration Government Management Medicine 84

Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

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Healthcare Healthcare Training Food and Drug Administration 52

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs kill more than 250,000 children a year, doctors warn. About the author. The Guardian.

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 90

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Some countries have blocked parallel trade to prevent supplies from depleting.

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Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.

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Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. Data governance and HIPAA rules around this are very clear—you can’t identify the individual.

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Food and Drug Administration Transportation Food Recruitment 52

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

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Food and Drug Administration Education Insurance Healthcare 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. How can we better educate the patients? How has the field changed in recent years?

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Food and Drug Administration Engineering Patients Education 59

Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. Data governance and HIPAA rules around this are very clear—you can’t identify the individual.

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Food and Drug Administration Transportation Food Recruitment 40

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 84

World of DTC Marketing

JUNE 22, 2021

Milton Friedman A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare patients could end up being higher than the budgets for the Environmental Protection Agency or NASA. Milton Friedman.

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Patients Food and Drug Administration Pharma Government 156

pharmaphorum

SEPTEMBER 28, 2022

Martin Mendoza, PhD, director of health equity and health science policy for the All of Us Research Program at the National Institutes of Health (NIH), tells pharmaphorum about the programme and how it will accelerate research for the benefit of all patients. Food and Drug Administration (FDA).

Medicine 85

Medicine Food and Drug Administration Medical FDA 85

World of DTC Marketing

NOVEMBER 2, 2021

Medicare’s innovation center may be the best avenue for lowering drug costs if provisions empowering government price negotiation don’t’ make it into a sweeping domestic spending package. For now, drug companies are free to overcharge Medicare for prescription drugs.

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Food and Drug Administration Pharma Prescription Government 231

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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Pharmaceutical Food and Drug Administration Medicine Manufacturing 74

Nixon Gwilt Law

DECEMBER 16, 2021

Partner Carrie Nixon seconds that by predicting “increasing adoption by providers of care management services like Remote Patient Monitoring, Behavioral Health Integration , and Chronic Care Management to improve outcomes for patients.” to the Firm in part to address the influx of SaMD client needs.

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Healthcare Healthcare Food and Drug Administration Ethics 52

MedCity News

JUNE 12, 2023

During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx. The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. An added benefit was the application of decentralized clinical trials (DCTs) to DTx.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Pfizer’s Paxlovid ( nirmatrelvir and ritonavir) treatment comprises a twice-daily three-pill antiviral regimen for five days designed to treat adult patients with Covid-19 by preventing the virus from spreading within the body. of patients between 18 and 64 years have taken at least one bivalent vaccine. In Q3 Pfizer earned $7.5

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pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.

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European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. We’ve learnt that innovative therapies, like Zolgensma, require equally inventive access pathways so that as many patients as possible benefit from treatment.

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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