European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Safety Transportation 79

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). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

Food and Drug Administration 92

Food and Drug Administration Safety Medicine Patients 92

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.

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

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. The application was accepted by the European Medicines Agency (EMA) on 26 January, signalling another significant breakthrough for both patients and experts working to address the disease.

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 89

Government Pharma Ethics Training 89

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc. Itatani, MD, Ph.D.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

European Pharmaceutical Review

JULY 13, 2023

However, even as science advances, there remain patients who still need new treatment options. 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.

Engineering 88

Engineering Food and Drug Administration Safety Patients 88

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. Not only can impurities lead to adverse effects in patients, but they can also introduce product variability. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

Food and Drug Administration 87

Food and Drug Administration Engineering Specialization Food 87

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” 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

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

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. When conservative care fails, these patients have limited treatment options. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

FEBRUARY 13, 2023

Anne Kerber, Senior Vice President, Cell Therapy Development at Bristol Myers Squibb explained the intention behind developing Abecma: “We sought to deliver a personalised therapy that provides durable outcomes with a single infusion to advance the multiple myeloma treatment paradigm for patients.” Ultimately, this goal proved successful.

Food and Drug Administration 114

Food and Drug Administration Engineering Safety Patients 114

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

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