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. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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Food and Drug Administration Manufacturing Side effects Doctors 105

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.

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Food and Drug Administration Healthcare Healthcare Food 69

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Food and Drug Administration Pharmacology Side effects Physicians 141

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals.

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Medicine Food and Drug Administration FDA Healthcare 98

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 74

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. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8].

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Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

JUNE 28, 2022

2 The estimated annual healthcare costs associated with circulatory disease in the UK is £9 billion. This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions. Within the UK alone, an estimated 7.6 2021 [cited 8 June 2022]. Available from: [link].

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Food and Drug Administration Medicine Patients FDA 98

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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Food and Drug Administration Manufacturing Medicine Pharma 105

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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Patients Food and Drug Administration Medicine Pharma 88

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

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Food and Drug Administration, 2023). Then, of course, there are the ethical considerations.

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Food and Drug Administration Pharmacology Food Engineering 52

World of DTC Marketing

MARCH 17, 2022

Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found. In 2018 cancer patients in the U.S. sustaining life)?

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Food and Drug Administration Medical Patients Ethics 255

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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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. One in insurance, retail and healthcare that is still around. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world.

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Sales Medical Medical sales Doctors 52

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.” The burden on patient functioning is also profound.

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Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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Manufacturing Food and Drug Administration Biopharma Sales 52

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. increase from 2018 to 2019.

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