European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. Lecanemab is a humanised antibody generated using protofibrils engineered from Aβ harbouring genetic mutations that cause familial AD.

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European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. With a myriad of potential techniques that could be applied to purify new protein drugs, years of experience will be needed to know the best approach to take to optimise yield, purity and cost.

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Food and Drug Administration Engineering Specialization Food 98

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.

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European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

Carisma develops chimeric antigen receptor macrophage (CAR-M) therapies and is said to be the only firm developing such therapies with proof of mechanism and safety findings shown in clinical trials. . Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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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. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

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Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement.

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Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.

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Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). ” CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. For additional important safety information, please see the CHG Instructions For Use.

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Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. ReGelTec, Inc. announced that the U.S. ABOUT REGELTEC, INC: ReGelTec, Inc. The HYDRAFIL System contains a hydrogel that can be injected into a degenerated disc via a needle.

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Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. To that end, iTFlow® provides a front-line software interface to measure kinetic energies, vortexes, and shear stresses inside the heart without the need for complex in-house engineering software.

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Pharma Marketing Network

OCTOBER 1, 2024

One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. Digital marketing strategies, including search engine optimization (SEO), content marketing, and online advertising, have become integral components of pharmaceutical marketing campaigns.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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Pharma Marketing Network

OCTOBER 3, 2024

A strong brand message conveys the unique value proposition of the pharmaceutical product, highlighting its benefits, efficacy, and safety. From social media and email marketing to search engine optimization and online advertising, digital channels provide cost-effective and measurable ways to promote pharmaceutical brands.

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European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

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Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

FEBRUARY 13, 2023

These T cells are engineered to be able to recognise cancer cells. The engineered cells are grown in large numbers. In the case of ide-cel, the T cells are engineered to recognise a protein called BCMA. A type of white blood cells called T cells are removed from the patient through a vein.

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Food and Drug Administration Engineering Safety Patients 116

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. Fake drugs kill more than 250,000 children a year, doctors warn. About the author. The Guardian.

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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. Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy.

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Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designations for Eagle Pharmaceuticals’ CAL02. Eagle expects to obtain eight to ten years of regulatory exclusivity for the therapy with QIDP, upon receipt of its new drug application approval.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Food and Drug Administration Safety Patients Leads 97

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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European Pharmaceutical Review

APRIL 8, 2025

One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals.

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