European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

Food and Drug Administration 80

Food and Drug Administration Manufacturing Safety Transportation 80

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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.

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

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?

Food and Drug Administration 93

Food and Drug Administration Safety Medicine Patients 93

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.

Food and Drug Administration 52

Food and Drug Administration Engineering Food Leads 52

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.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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.

Food and Drug Administration 75

Food and Drug Administration Safety Medicine FDA 75

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.

Government 90

Government Pharma Ethics Training 90

European Pharmaceutical Review

JULY 13, 2023

By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer. Since then, several next-generation antibodies have been engineered with modifications that enable them to better engage with immune cells.

Engineering 89

Engineering Food and Drug Administration Safety Patients 89

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

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.

Food and Drug Administration 88

Food and Drug Administration Engineering Specialization Food 88

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.

Manufacturing 86

Manufacturing Pharma Food and Drug Administration Safety 86

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.

Food and Drug Administration 79

Food and Drug Administration Safety Patients Leads 79

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.

Food and Drug Administration 114

Food and Drug Administration Engineering Safety Patients 114

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.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52