Quality Systems
Preserving Process Integrity: The Importance of Equipment Cleaning
September 03, 2023
A structured cleaning procedure is essential to ensure the effective cleaning of equipment.
Accelerating Clinical Trials in the EU
September 02, 2023
The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.
Clinical Trials and their Impact on the Pharma Industry
September 02, 2023
There are many promising trials in the pipeline that may bring big news for major therapeutic areas.
Clearing Up Confusion in Inspection Terminology
September 02, 2023
Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.
White House Sets Medicare Price Negotiation Targets
August 31, 2023
The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.
FDA Approves Bristol Myers Squibb Anemia Treatment
August 31, 2023
Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.
Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine
August 31, 2023
The updated vaccine will be ready to ship following a positive European Commission review.
FDA Approves Biosimilar to Treat Multiple Sclerosis
August 30, 2023
This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.
Discussing the State of Pharma with Congressman Adam Smith
August 25, 2023
Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.
Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases
August 24, 2023
The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.