European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. billion in 2022, a product that was launched in 2002. The Soliris (eculizumab) biosimilar is indicated as a treatment for patients with the rare haematology disorder paroxysmal nocturnal haemoglobinuria (PNH).

Marketing 97

Marketing Food and Drug Administration Food Medicine 97

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. The drug is currently under review in Australia, the EU and Switzerland.

FDA 97

FDA Food and Drug Administration Food Pharmaceutical 97

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

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Food and Drug Administration Medicine Safety Consulting 105

pharmaphorum

SEPTEMBER 13, 2022

Over the past two centuries, researchers have identified more than 100 different types of blood cancer, while most patients may be familiar with the big three (leukaemia, lymphoma, and melanoma). In 39-year-old patient Sarah Newbury, Solly observed the appearance of fatigue and bone pain resulting from multiple fractures.

Food and Drug Administration 98

Food and Drug Administration Patients Engineering Physicians 98

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 97

Food and Drug Administration Safety Patients Leads 97

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 98

Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

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Food and Drug Administration Medicine FDA Marketing 52