Uncategorized – Page 5

Recent Developments in Logistical Coordination for Decentralized Clinical Trials (DCTs)

7 days ago talkbio0Tagged Clinical Trials, decentralized, Digital Trial, Guidance 2024, Logistics, platforms, Preventive monitoring, Remote, supply chain management, United States Food and Drug Administration

Decentralized Clinical Trials; Logistics; FDA Guidance 2024; Remote Patient Monitoring; Supply Chain Management; Digital Trial Platforms

RFK Jr. Faces Bipartisan Senate Criticism After CDC Shakeup

7 days ago talkbio0Tagged bipartisan criticism, Centers for Disease Control and Prevention (U.S.), director firing, Policy, public health medicine (field), RFK Jr., Senate hearing, Shakeup, Trump administration reforms, Vaccines

RFK Jr.; CDC shakeup; bipartisan criticism; Senate hearing; public health; vaccine policy; CDC director firing; Trump administration reforms

Enveda Raises $150M Series D, Advances Nature-Inspired Drug Programs

7 days ago talkbio0Tagged Biosciences, Dermatitis, Atopic, Enveda, Immune System Diseases, Investments, Mikael, nature-inspired drug discovery, Series D

Enveda Biosciences; Series D funding; $150 million; nature-inspired drug discovery; atopic dermatitis; immune diseases; Mikael Dolsten; biotech investment

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

7 days ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, Translucent, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Atlas Venture Raises $400M Opportunity Fund to Bolster Biotech Portfolio

7 days ago talkbio0Tagged Biopharma, biotech startups, Cervical Atlas, Investments, Late stage, M growth fund, Opportunity Fund III, portfolio support, venture

Atlas Venture; $400M growth fund; biotech startups; Opportunity Fund III; portfolio support; venture capital; late-stage funding; biopharma investment

FDA Pushes Back Agios’ Pyrukynd Thalassemia Decision to December

7 days ago talkbio0Tagged Agios, decision delay, Liver damage, PDUFA, Pyrukynd, REMS, Thalassemia, United States Food and Drug Administration

FDA; Agios; Pyrukynd; thalassemia; PDUFA; decision delay; REMS; hepatocellular injury

Survival Benefit of Amgen’s Bemarituzumab in Gastric Cancer Attenuates at Final Analysis

7 days ago talkbio0Tagged amgen, Attenuated by (contextual qualifier), bemarituzumab, Benefit, final analysis, FORTITUDE-101, FORTITUDE-102, Malignant neoplasm of stomach, nivolumab, Opdivo, Overall Survival, Zai Lab

Amgen; bemarituzumab; gastric cancer; Phase 3 trial; overall survival; attenuated benefit; final analysis; FORTITUDE-101; FORTITUDE-102; Zai Lab; Opdivo; nivolumab