Biologically Active Substance – Page 4

May the (Power of the) Pool be with you: Accelerating time from DNA to GMP – STI-based CLD Platform

2 months ago talkbio0Tagged Biopharma, cell line development, DNA, Endpoints, Guanosine Monophosphate, Platform, STI-based, time acceleration, webinar

DNA to GMP; STI-based CLD Platform; bioprocessing; Endpoints News; webinar; cell line development; biopharma; time acceleration

FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

2 months ago talkbio0Tagged Andembry, Angioedemas, Hereditary, Approved, dosing, factor XIIa, garadacimab-gxii, Inhibitor, SMPX gene, Subcutaneous Injections, Takeda, Takhzyro, United States Food and Drug Administration

Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection

Gilead Lays Off 36 Employees After Cancelling Oceanside, California Expansion

2 months ago talkbio0Tagged Biological Factors, biotech industry, California, co-location, expansion, Facility (object), Foster City, Gilead Sciences, layoffs, Oceanside

Gilead Sciences; layoffs; Oceanside; California; biologics; facility expansion; job cuts; biotech industry; co-location; Foster City

UCB Announces Major Investment to Expand US Biologics Manufacturing Capacity

2 months ago talkbio0Tagged Biological Factors, biomanufacturing, economic impact, expansion, Investments, Manufacturing, U.S., UCB

UCB; biologics manufacturing; US expansion; biomanufacturing; biopharmaceutical; investment; jobs; economic impact

Merck’s Oral PCSK9 Inhibitor Enlicitide Significantly Reduces LDL Cholesterol in Phase 3 Trials

2 months ago talkbio0Tagged Administration of prophylactic statin, cholesterol, CORALreef, CORALreef AddOn, enlicitide, HeFH, Hypercholesterolemia, Familial, Hyperlipidemia, LDL-C, Merck, Oral Therapy, PCSK9 inhibitor

Merck; PCSK9 inhibitor; enlicitide; phase 3 trials; cholesterol; LDL-C; oral therapy; hyperlipidemia; familial hypercholesterolemia; CORALreef HeFH; CORALreef AddOn; statin therapy

EMA Identifies Very Rare Eye Condition as Side Effect of Semaglutide

3 months ago talkbio0Tagged Adverse effects, Blindness, Infrequent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, NAION, Ozempic, Rybelsus, semaglutide, Wegovy

EMA; semaglutide; rare side effect; NAION; vision loss; Ozempic; Wegovy; Rybelsus

Vigil’s Iluzanebart Fails Phase 2 in Rare Neuro Disease; Sanofi Takeover Remains On Track

3 months ago talkbio0Tagged Agonist, amgen, Hereditary Diffuse Leukoencephalopathy with Spheroids, iluzanebart, Neuro Disease, Sanofi acquisition, TREM2, VG-3927, Vigil

Vigil Neuroscience; iluzanebart; Phase II IGNITE trial; rare neuro disease; ALSP; Sanofi acquisition; Amgen; TREM2 agonist; VG-3927

Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

3 months ago talkbio0Tagged Acne Vulgaris, Ascletis, Biosciences, Chinese study, clinical endpoints, Clinical Trials, Denifanstat, Inhibitor, Lesion, oral FASN, Phase 3, Sagimet

Ascletis; Sagimet Biosciences; denifanstat; oral FASN inhibitor; phase 3 clinical trial; acne vulgaris; clinical endpoints; lesion reduction; Chinese study

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

3 months ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

BioAge Signs Option Agreement for Obesity Asset from Chinese Biotech Following APJ Agonist Setback

3 months ago talkbio0Tagged Agonist, APJ, BioAge, Exercise, incretin therapy, Metabolic Diseases, mimetics, nanobody, Obesity, small molecule agonists

BioAge; JiKang Therapeutics; obesity; APJ agonist; option agreement; nanobody; small molecule agonists; exercise mimetic; incretin therapy; metabolic diseases