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 87

Food and Drug Administration Manufacturing Management Safety 87

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings.

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Food and Drug Administration FDA Government Medicine 106

Pharmaceutical Technology

JULY 21, 2022

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

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Food and Drug Administration Government Pharma Healthcare 98

Pharmaceutical Technology

FEBRUARY 14, 2023

It will also support smaller dose vials development, selection of strain as per the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market.

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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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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 94

World of DTC Marketing

APRIL 7, 2021

I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. drug spending by 9 percent” What about taxpayers? Highest-paid CEOs in 2019: Who made the list from healthcare.

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Healthcare Healthcare Food and Drug Administration Pharma 162

Pharmaceutical Technology

AUGUST 1, 2022

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. 4/5 Omicron strain is being developed in line with the latest recommendations from the Food and Drug Administration (FDA). 4/5 strain messenger RNA (mRNA).

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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

MARCH 6, 2023

This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022. This exciting milestone follows finalization of Moderna’s ten-year strategic partnership with the UK government in December 2022.

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Manufacturing Food and Drug Administration Government Food 89

Pharmaceutical Technology

JULY 7, 2022

In December last year, China’s National Medical Products Administration (NMPA) granted approval for amubarvimab/romlusevimab combination to treat mild and normal Covid-19 in adults and paediatric patients aged 12 to 17 years. The initial commercial batch of the antibody therapy was released on 7 July this year.

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Food and Drug Administration Distribution Government Food 105

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 103

Medicine Food and Drug Administration Ethics Government 103

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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Manufacturing Food and Drug Administration FDA Pharma 52

European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. US FDA granted approval of Abrysvo to Pfizer Inc.

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Food and Drug Administration FDA Government Food 88

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 83

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

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

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing. Food and Drug Administration.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 98

World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. A chief reason for the speedy turnaround was a decision the federal government made to expedite delivery of the vaccine — which has nothing to do with the scientific validity of the drug itself.

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Food and Drug Administration Government Safety Side effects 203

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

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 121

Medicine Food and Drug Administration Doctors Government 121

Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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Pharmaceutical Technology

JULY 12, 2022

Novavax has signed an agreement with the US Department of Health and Human Services (HHS), in partnership with the Department of Defense, under which the US government will procure 3.2 million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage.

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Food and Drug Administration FDA Government Physicians 64

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. . Jennifer L.

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Food and Drug Administration Medical Patients FDA 73

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 91

Pharmaceutical Technology

SEPTEMBER 12, 2022

In accordance with the recommendations of the Canadian government and public health authorities across the country, the companies plan to commence shipping the 3?g g dose of the vaccine a minimum of two months following the second dose when the Omicron variant of the SARS-CoV-2 virus was prevalent.

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Food and Drug Administration Government Food Safety 52

Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

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Food and Drug Administration Pharmaceutical Sales Medicine 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

On 1 September, the US Food and Drug Administration (FDA) approved both Pfizer/BioNTech and Moderna's Omicron-specific Covid-19 vaccine boosters. Pfizer and BioNTech’s booster has been approved for those aged 12 years and older, while Moderna’s is currently only approved for those aged 18 years and older.

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Food and Drug Administration FDA Government Food 52

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).

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

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 97

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 95

Pharma Marketing Network

JULY 10, 2023

This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug. This type of advertising is often used to provide information about the benefits and risks of a particular drug.

Healthcare 40

Healthcare Healthcare Marketing Pharma 40

Legacy MEDSearch

JULY 21, 2023

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. Christophe Vaessen.

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Food and Drug Administration Patients Safety Recruitment 52

Clarify Health

NOVEMBER 21, 2022

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Data governance and HIPAA rules around this are very clear—you can’t identify the individual. It’s a win-win-win for everyone.”.

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Food and Drug Administration Transportation Food Recruitment 52

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]. 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52