Biologically Active Substance

Eli Lilly’s Oral GLP-1 Orforglipron Outperforms Semaglutide in Diabetes and Weight Loss Trials

1 day ago talkbio0Tagged Diabetes Mellitus, Non-Insulin-Dependent, Eli Lilly, Glucagon-Like Peptide 1, Nordisk, Oral cavity, orforglipron, semaglutide, Weight Loss

Lilly; orforglipron; oral GLP-1; semaglutide; type 2 diabetes; weight loss; phase 3 trial; Novo Nordisk

Ollin Biosciences Launches with $100M to Challenge Roche in Eye Disease Market

1 day ago talkbio0Tagged Ang2, Biosciences, Clinical Trials, Disorder of eye, Macular edema due to diabetes mellitus, Ollin, OLN324, Roche (company), Vabysmo, Vascular Endothelial Growth Factor A, Wet AMD

Ollin Biosciences; Roche; eye disease; biotech; VEGF-A; Ang2; wet AMD; diabetic macular edema; clinical trial; OLN324; Vabysmo

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

1 week ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

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

1 week 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

1 week 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

1 week 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

1 week 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

1 week 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

2 weeks 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

2 weeks 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