September 10, 2024

FDA Advisors Seek Narrower Indication for Iterum’s Oral Sulopenem in Treating Uncomplicated Urinary Tract Infections

8 months ago talkbio0Tagged AMDAC, Iterum, Microbicides, oral sulopenem, Resistance (Psychotherapeutic), United States Food and Drug Administration, Urinary tract infection, uUTIs

FDA, Iterum Therapeutics, oral sulopenem, uncomplicated urinary tract infections (uUTIs), antimicrobial resistance, Antimicrobial Drugs Advisory Committee (AMDAC)

GSK to Close UK Antibiotic Factory in Ulverston Following Sandoz Contract Termination

8 months ago talkbio0Tagged Antibiotic Factory, Contract agreement, losses, Reparative closure, sandoz, SmithKline Beecham, Ulverston

GSK, Ulverston, antibiotic factory, Sandoz contract, closure, job losses

Enhancing Flu Vaccine Manufacturing and Supply: A Comprehensive Overview

8 months ago talkbio0Tagged Influenza virus vaccine, Manufacture, pandemic preparedness, production, Supply Chain Reliability, Technology, Vaccines

Flu Vaccine Manufacturing, Supply Chain Reliability, Influenza Vaccine Production, Vaccine Manufacturing Technologies, Pandemic Preparedness

AstraZeneca and Daiichi Sankyo’s Dato-DXd Fails to Meet Overall Survival Goal in NSCLC Study, FDA Decision Looms

8 months ago talkbio0Tagged AstraZeneca, Clinical Research, Daiichi, Dato-DXd, Datopotamab deruxtecan, Decision, Non-Small Cell Lung Carcinoma, Overall Survival, Sankyo, TROPION-Lung01, United States Food and Drug Administration

AstraZeneca, Daiichi Sankyo, Dato-DXd (datopotamab deruxtecan), Non-small cell lung cancer (NSCLC), Overall survival (OS), FDA decision, TROPION-Lung01 study

WHO Publishes First Guidance to Combat Antibiotic Pollution from Manufacturing

8 months ago talkbio0Tagged Administration occupational activities, AMR, antibiotic pollution, Antimicrobial Resistance, Environmental Health, Microbicides, pharmaceutical manufacturing, solid waste management, Wastewater, World Health Organization

WHO, antibiotic pollution, antimicrobial resistance (AMR), wastewater management, solid waste management, pharmaceutical manufacturing, environmental health

BIOSECURE Act Clears House Hurdle, Heads to Senate for Vote on Restricting Chinese Biotech Ties

8 months ago talkbio0Tagged BIOSECURE, Biotech Companies, Biotechnology, Chinese Language, Drug Industry, drug supply chain, innovation, National Security, Risk, Senate, United States, US House of Representatives, Voting

BIOSECURE Act, House of Representatives, Senate Vote, Chinese Biotech Companies, National Security Risks, U.S. Pharmaceutical Industry, Biotechnology Innovation, Drug Supply Chain