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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Food and Drug Administration Government Medicine Food 64

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?

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Food and Drug Administration Manufacturing Management Safety 77

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.

Medicine 96

Medicine Food and Drug Administration Ethics Government 96

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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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

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 85

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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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 73

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 81

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. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. About the author.

Medicine 88

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 88

Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. does not currently have centralized insurance coverage for pediatric healthcare.

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Food and Drug Administration Education Insurance Healthcare 52

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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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

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 81

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 81

Medicine Food and Drug Administration Medical FDA 81

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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Food and Drug Administration Safety FDA Ethics 10

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 71

MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx.

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Food and Drug Administration Prescription Government FDA 85

Medico Reach

OCTOBER 17, 2022

What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Healthcare executives are also looking into AR spinal surgical systems. Let’s dive right in!

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

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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Food and Drug Administration Government Healthcare Healthcare 67

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. In Q3 Pfizer earned $7.5 Paxlovid rebound study.

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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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pharmaphorum

OCTOBER 3, 2022

Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. It also would be in line with emerging markets’ ambitions to grant patients access to the latest, on-patent, innovative medicines. However, even then, challenges could remain.

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Food and Drug Administration Consulting Marketing Manufacturing 86

European Pharmaceutical Review

DECEMBER 15, 2022

Psilocybin therapy in mental healthcare. Mental healthcare should promote optimal quality of life through preventing, treating and managing mental health illnesses, such as depression, with the aim of facilitating sustained recovery. The introduction of psilocybin therapy could provide a potential step-change in mental healthcare.

Food and Drug Administration 69

Food and Drug Administration Healthcare Healthcare Food 69

Medico Reach

OCTOBER 17, 2022

What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Healthcare executives are also looking into AR spinal surgical systems. Let’s dive right in!

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Pharma Food and Drug Administration Manufacturing Medicine 122

pharmaphorum

JANUARY 30, 2023

This poses significant issues for healthcare systems in those countries, as those in the Northern Hemisphere are dealing with infectious diseases that commonly occur in winter. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 83

World of DTC Marketing

JULY 12, 2022

Patients on Medicare who don’t qualify for low-income subsidies could see out-of-pocket costs for the drug of over $12,000. Isn’t it time for Congress to finally pass legislation that helps patients? There are also programs administered through state governments that can help with healthcare-related needs.

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Healthcare Healthcare Food and Drug Administration Government 227

Evolve Your Success

FEBRUARY 7, 2023

He discusses why the future of the healthcare industry in the United States lies not in hospital buildings but in surgery centers. The patients like that their copay is lower. Patients have a lower copay. One in insurance, retail and healthcare that is still around. It’s the first drug-eluting heart stent in the world.

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Medical Sales Medical sales Doctors 52

World of DTC Marketing

JANUARY 28, 2021

SUMMARY: The current state of healthcare is unsustainable. The federal government has paid almost $4 billion to Pfizer for 200 million doses. Now, the US government has paid again for this vaccine through a $3.2 In a Pew Research study from March 2019, drug manufacturers paid PBMs $10.2 Please read that again.

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Healthcare Healthcare Food and Drug Administration Insurance 180

Pharma Marketing Network

JUNE 11, 2020

You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. They would write up the presentations by physicians about drugs. He was Chief of a Healthcare Marketing company in Philadelphia.

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Media Pharma Ethics Consulting 52

Legacy MEDSearch

JULY 20, 2023

Food and Drug Administration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. We are just at the beginning of a journey seeing the clinical adoption of game-changing data and digital healthcare solutions.” MediView XR, Inc.,

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FDA Food and Drug Administration Recruitment Healthcare 52

Cadensee

JULY 20, 2021

He is one of the first advocates for patient centric health care more than a decade ago when patient opinions and requests were not part of the equation in the system. Uri founded and continues to contribute insights through his digital magazine, e-Pochonder and is one of the first advocates for patient centric health care.

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Food and Drug Administration Doctors Healthcare Healthcare 52

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

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Pharma Food and Drug Administration Safety Medicine 98

World of DTC Marketing

APRIL 7, 2022

Right now, voters are worried about inflation and rising fuel prices, but they ignore the imminent threats to their healthcare. American healthcare continues to be under assault, and unless we address these issues, a severe health issue could bankrupt families. THREAT 3: RISING HEALTHCARE COSTS. THREAT 1: OBESITY AND DIABETES.

Healthcare 215

Healthcare Healthcare Food and Drug Administration Government 215

World of DTC Marketing

JULY 20, 2021

The authority of state governments to mandate vaccinations is clear — it goes all the way back to a 1905 Supreme Court case. The findings don’t mention that those who fail to get vaccinations are putting healthcare workers and others at risk and that herd immunity may be impossible. of the population.”

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