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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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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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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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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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

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

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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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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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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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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Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. The treatment landscape is therefore one that is relatively bare.

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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. . Jennifer L.

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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. 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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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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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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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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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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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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pharmaphorum

NOVEMBER 16, 2022

“They say need for two product licences under the Centralised Procedure ‘creates an administrative and cost burden that will make many medicines unviable to supply to NI’ This level of disruption is unacceptable and unjustifiable.” “The warning presented by Teva UK is stark,” according to Cameron.

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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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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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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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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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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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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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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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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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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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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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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?

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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. Saneso Inc., This can cause them to miss 25-40% of polyps.

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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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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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pharmaphorum

SEPTEMBER 28, 2022

Food and Drug Administration (FDA). Jessica Hagen is a freelance life sciences and health writer and project manager who has worked with medical XR companies, fiction/nonfiction authors, nonprofit and for-profit organisations, and government entities.

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European Pharmaceutical Review

NOVEMBER 15, 2022

Stephen has 20 plus years of IT Compliance experience in the regulated Life Sciences and currently leads the IT Governance & Software Assurance practices within CompliancePath an Ideagen company. . The post GAMP 5 update: computerized system expectations for pharma manufacturers appeared first on European Pharmaceutical Review.

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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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