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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European Pharmaceutical Review

JANUARY 23, 2025

4 Looking ahead, China is becoming an increasingly important research and development (R&D) target for companies seeking to license-in antibody-drug conjugates (ADCs) and other novel oncology treatments. 4 Article: Potential blockbuster drugs to watch in 2025 How will AI shape pharma in 2025? EY (Ernst & Young). cited 2025Jan].

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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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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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Pharmaceutical Technology

JUNE 23, 2022

As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. Allowing for real-time process monitoring during drug production can help with continuous manufacturing. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.

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Manufacturing Government Food and Drug Administration FDA 64

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

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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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. US FDA granted approval of Abrysvo to Pfizer Inc. This news follows similar regulatory action by the US FDA in recent months.

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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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Medicine Food and Drug Administration Ethics Government 105

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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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 Medicine Government 105

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.

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Medicine Food and Drug Administration Doctors Medical 131

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. It was developed using the recombinant nanoparticle technology of Novavax.

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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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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 Presently, the EUA application for the vaccine submitted by the company is being reviewed by the FDA.

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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. 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

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 98

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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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]. N Engl J Med.

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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. The power rests with Europe and the UK.

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Legacy MEDSearch

JUNE 10, 2022

a leading US developer of next gen endoscope systems announces today the US Food and Drug Administration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope. See Full Press Release at the Source: Saneso Novel 360° Colonoscope Receives FDA Clearance. Saneso Inc.,

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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.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

pharmaphorum

JANUARY 30, 2023

Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs. As such, new strategies have to be devised to encourage continued investment into the area.

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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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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

Medico Reach

OCTOBER 17, 2022

Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. Hence, there are obstacles like restrictive, albeit necessary, government regulations.

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Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. State Government of Victoria, Australia; 2015 [Cited 2022Nov]. Mental health care [Internet].

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Food and Drug Administration Healthcare Healthcare Food 69

Legacy MEDSearch

JULY 20, 2023

Food and Drug Administration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. “MediView is excited to receive 510(k) clearance for our XR90 platform and appreciate the team’s efforts and FDA’s partnership in achieving this milestone. .”

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FDA Food and Drug Administration Recruitment Healthcare 52

European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

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Manufacturing Pharma Food and Drug Administration Safety 98

pharmaphorum

SEPTEMBER 28, 2022

Food and Drug Administration (FDA). He is a recognised expert in clinical trial diversity and while at the FDA testified before Congress in support of diverse clinical research inclusion. Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials.

Medicine 98

Medicine Food and Drug Administration Medical FDA 98

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. What’s holding this back?

Medicine 52

Medicine Food and Drug Administration Government Insurance 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

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Its development is being supported by the nonprofit CARBX, which is tackling antibiotic resistance, and recently received UK government funding to develop new treatments.

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Food and Drug Administration Safety Side effects FDA 98

Legacy MEDSearch

JULY 21, 2023

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. Christophe Vaessen. STeP participation does not imply product authorization.

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Food and Drug Administration Patients Safety Recruitment 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

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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Pharmaceutical Technology

JUNE 30, 2022

According to Bolkvadze: “It may be that in the future, the government considers another requirement for a GDP license partner to act as Importer of Record and be capable of handling investigational medical products.

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