Biologically Active Substance – Page 8

Odyssey Therapeutics Secures $213M Series D to Accelerate Autoimmune Clinical Portfolio

3 months ago talkbio0Tagged Autoimmune Diseases, clinical pipeline, Immunoregulation, Inhibitor, investors, Odyssey, Precision - temporal, preclinical programs, Protac, RIPK2, Series D financing, Technology

Odyssey Therapeutics; Series D financing; $213 million; autoimmune diseases; clinical pipeline; preclinical programs; precision immunomodulation; RIPK2 inhibitor; PROTAC technology; investors

ICER Draft Report: High-Cost GLP-1 Obesity Drugs Deemed Cost-Effective—Affordability Still a Concern

3 months ago talkbio0Tagged Affordability, cardiovascular benefits, Cost-Effectiveness, CREM gene, Glucagon-Like Peptide 1, Health Policy, Obesity, semaglutide, tirzepatide, value-based pricing

ICER; GLP-1; semaglutide; tirzepatide; obesity drugs; cost-effectiveness; health policy; affordability; value-based pricing; cardiovascular benefits

Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates

4 months ago talkbio0Tagged agonists, alixorexton, Alkermes, Cataplexy, Clinical Trials, Daytime Somnolence, Excessive (qualifier value), Maintenance, MWT, Narcolepsy, orexins, oveporexton, Phase 3, Takeda, Wakefulness Test

Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)

BioNTech and BMS Announce First Global Data for PD-L1xVEGF Bispecific in Small Cell Lung Cancer, Set Phase 3 Dose

4 months ago talkbio0Tagged BioNTech, BNT327, Burning Mouth Syndrome, Myers, Overall response rate, PD-L1, PD-L1xVEGF, Pharmacotherapy, pumitamig, Small cell carcinoma of lung, squibb, Vascular Endothelial Growth Factor A

BioNTech; Bristol Myers Squibb; BMS; PD-L1xVEGF bispecific; BNT327; pumitamig; small cell lung cancer; SCLC; phase 2 trial; phase 3 dose; overall response rate; VEGF-A; PD-L1; chemotherapy

FDA Shifts Approach on GLP-1 Compounding: Announces Consumer Green List Instead of Immediate Crackdown

4 months ago talkbio0Tagged Compound, Consumer Safety, Drug shortages, Glucagon-Like Peptide 1, green list, import alert, Regulation, semaglutide, United States Food and Drug Administration

FDA; GLP-1; compounding; green list; drug shortages; semaglutide; tirzepatide; import alert; consumer safety; regulation

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

4 months 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

FDA Announces New Rare Disease Approval Programme

4 months 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

4 months 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

Editas Medicine Reboots With Cholesterol Gene Therapy (EDIT-401) as Lead Asset

4 months ago talkbio0Tagged Clinical Development, EDIT-401, Editas Medicine, Gene Modification, gene therapy, Hyperlipidemia, in vivo, LDL Cholesterol Lipoproteins, LDLR gene, strategic pivot

Editas Medicine; EDIT-401; gene therapy; hyperlipidaemia; LDL cholesterol; LDLR gene; in vivo gene editing; strategic pivot; clinical development

Merck’s Oral PCSK9 Inhibitor Enlicitide Decanoate Achieves Third Consecutive Phase 3 Success

4 months ago talkbio0Tagged Administration of prophylactic statin, Clinical Trials, CORALreef Lipids, enlicitide decanoate, Hypercholesterolemia, LDL Cholesterol Lipoproteins, Merck, Oral cavity, oral PCSK9, PCSK9 inhibitor

Merck; oral PCSK9 inhibitor; enlicitide decanoate; Phase 3 trials; CORALreef Lipids; hypercholesterolemia; lowering LDL cholesterol; statin therapy; first oral PCSK9; clinical trial results