Phase 3 Clinical Trials

Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

1 week ago talkbio0Tagged Clinical Trials, Depression, Postpartum, Montgomery-Åsberg Depression Rating Scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Neuroscience discipline, Phase 2 Clinical Trials, Phase 3 Clinical Trials, psychedelic therapy, RE104, RECONNECT, remission rates, Reunion

Reunion Neuroscience; RE104; psychedelic therapy; postpartum depression (PPD); Phase II trial; Phase III trial; RECONNECT trial; clinical trial results; Montgomery-Åsberg Depression Rating Scale (MADRS); remission rates

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

3 weeks ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab

4 weeks ago talkbio0Tagged Alzheimer 's disease, amyloid-lowering drug, Biological Markers, Brainshuttle, Drug Development, Interventional procedure, Phase 3 Clinical Trials, Roche (company), TRONTIER, Trontinemab

Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention

Viatris Ophthalmic Drug Fails Phase 3 for Blepharitis; Company Weighs Next Steps

1 month ago talkbio0Tagged Blepharitis, Clinical trial failure, Drug Development, MR-139, ophthalmic preparation, Phase 3 Clinical Trials, pimecrolimus, pipeline, strategic review, Viatris

Viatris; ophthalmic drug; Phase 3 study; blepharitis; MR-139; clinical trial failure; drug development; pimecrolimus; pipeline; strategic review

Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings

1 month ago talkbio0Tagged Clinical Trials, File (record), Narcolepsy, Narcolepsy type 1, orexin agonist, oveporexton, Phase 3 Clinical Trials, Takeda, United States Food and Drug Administration

Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results

Roche Advances Prasinezumab Into Phase III Trials for Parkinson’s Despite Mixed Phase II Results

2 months ago talkbio0Tagged alpha-synuclein antibody, Biological Markers, Clinical Trials, disease-modifying treatment, PADOVA study, Parkinson 's disease, Pasadena, Phase 3 Clinical Trials, Prasinezumab, Prothena, Roche (company)

Roche; prasinezumab; Parkinson’s disease; Phase III trial; clinical trials; alpha-synuclein antibody; Prothena; PADOVA study; PASADENA study; biomarker; disease-modifying treatment

Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results

3 months ago talkbio0Tagged Clinical Trials, Engaged to be married, Insmed, PAH, Phase 3 Clinical Trials, Pulmonary arterial hypertension, TPTE2 gene, treprostinil palmitil inhalation powder, United States Food and Drug Administration

Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement

Prothena Halts Drug and Plans Major Layoffs After Second Rare Disease Trial Failure

3 months ago talkbio0Tagged AL, birtamimab, business options, drug failure, layoffs, Phase 3 Clinical Trials, Primary amyloidosis, Prothena, spending

Prothena; birtamimab; AL amyloidosis; Phase III trial; drug failure; layoffs; biotech; spending cuts; business options

AstraZenecas Truqap Posts Another Pivotal Disappointment as Phase III Prostate Cancer Study Fails

4 months ago talkbio0Tagged ADT, androgen-deprivation therapy, AstraZeneca, CAPItello-280, capivasertib, Clinical Trials, Discontinuation (procedure), docetaxel, Failure (biologic function), Inhibitor, Metastatic castration-resistant prostate cancer, oncology setback, Phase 3 Clinical Trials, Progression-Free Survival, Proto-Oncogene Proteins c-akt, Radiographic, Survival, Truqap

Truqap, capivasertib, AstraZeneca, Phase III trial failure, CAPItello-280, metastatic castration-resistant prostate cancer (mCRPC), AKT inhibitor, docetaxel, androgen-deprivation therapy (ADT), oncology setback, clinical trial discontinuation, radiographic progression-free survival, overall survival

Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss

4 months ago talkbio0Tagged Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Hemoglobin A1c measurement, Injectables, Oral cavity, orforglipron, Phase 3 Clinical Trials, Safety, Weight Loss

orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables