ORG – Page 5 – Talk Bio

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

Sanofi Phase 3 Eczema Win Falls Short of Analyst Expectations

1 week ago talkbio0Tagged Amlitelimab, Dermatitis, Atopic, Dupixent, EASI-75, Eczema, Expectations, Market, Reaction, sanofi

Sanofi; amlitelimab; phase 3 trial; eczema; atopic dermatitis; analyst expectations; Dupixent; EASI-75; market reaction

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

1 week ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

Wave RNA Editing Restores Enzyme in Genetic Disorder but Fails to Impress Investors

1 week ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, enzyme restoration, Investor Reaction, RNA Editing, Wave Life Sciences, WVE-006

Wave Life Sciences; RNA editing; AATD; alpha-1 antitrypsin deficiency; enzyme restoration; clinical trial; investor reaction; WVE-006

Treeline Announces $200M Funding Boost, Moves Three Cancer Drugs into Clinic

1 week ago talkbio0Tagged BCL6 gene, cancer drugs, Clinical Trials, Degrader, EZH2 protein, human, Funding, Inhibitor, K-ras Oncogene, Lymphoma, Series, Solid Neoplasm, TLN-121, TLN-254, TLN-372, Treeline

Treeline Biosciences; cancer drugs; clinical trials; TLN-121; TLN-372; TLN-254; BCL6 degrader; KRAS inhibitor; EZH2 inhibitor; Series A funding; lymphoma; solid tumors

Novartis Again Partners with Argo Biopharma in $5.2B+ RNAi Cardiovascular Deal

1 week ago talkbio0Tagged ANGPTL3, Biopharma, biotech collaboration, cardiovascular pipeline, Drug Development, Dyslipidemias, milestone payments, Novartis, RNA Interference, RNA, Small Interfering

Novartis; Argo Biopharma; RNA interference (RNAi); siRNA; cardiovascular pipeline; ANGPTL3; dyslipidemia; biotech collaboration; drug development; milestone payments

FDA Announces New Rare Disease Approval Programme

1 week ago talkbio0Tagged Accelerated, Approved, Biological Factors, conditional approval pathway, drug review, Endpoints, Infrequent, real-world data, streamlined process, Surrogate, United States Food and Drug Administration

FDA; rare disease; conditional approval pathway; accelerated approval; biologics; drug review; surrogate endpoints; real-world data; streamlined process

Gilead Unveils New Manufacturing Site in California as Part of $32B U.S. Investment Plan

1 week ago talkbio0Tagged Billion, Biological Factors, California, economic impact, expansion, Foster City, Gilead Sciences, Investments, Manufacturing, Manufacturing Facilities, R&D, Surgical construction, United States

Gilead Sciences; Foster City; California; manufacturing facility; biopharmaceuticals; $32 billion investment; economic impact; expansion; R&D; job creation; U.S. manufacturing

Wave Life Sciences Shares Dip After Mixed Data Update on GSK-Partnered AATD Therapy

1 week ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, protein levels, RNA Editing, SmithKline Beecham, Wave Life Sciences, WVE-006

Wave Life Sciences; GSK; AATD; RNA editing; WVE-006; clinical trial; protein levels; stock dip; biotech