Research Activity – Page 66

FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients

1 year ago talkbio0Tagged 12.5 mg, Approved, aprocitentan, aspects of adverse effects, Availability of, Clinical Trials, Combined Modality Therapy, Edema, Endothelin receptor antagonist, Idorsia, Intravascular systolic:Pressure:Point in time:Arterial system:Quantitative, Liquid substance, Precision - temporal, Recommended dosage, Resistant hypertensive disorder, Retention (Psychology), Second Half of 2024, Tryvio, Uncontrolled hypertension, United States Food and Drug Administration

FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects

Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing

1 year ago talkbio0Tagged Acromegaly, Crinetics, Oral treatment, Paltusotine, Phase 3 Clinical Trials, Submission, Symptom reduction, United States Food and Drug Administration

Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction

Bayer’s Menopause Drug Elinzanetant Achieves Successful Long-Term Results in Phase III Trial, Rivalling Astellas’ Veozah

1 year ago talkbio0Tagged Astellas, Bayer, competition, Elinzanetant, Hot flushes, Long-term, Menopause, Phase 3 Clinical Trials, vasomotor symptom, Veozah

Bayer, Elinzanetant, Menopause drug, Phase III trial, Long-term results, Hot flashes, Vasomotor symptoms, Astellas, Veozah, Competition

Contineum Launches IPO Campaign to Accelerate Multiple Sclerosis Pipeline

1 year ago talkbio0Tagged Backed, Contineum, IPO, Johnson and Johnson, Multiple Sclerosis, Phase 2 Clinical Trials, PIPE-307, Public Offering

Contineum Therapeutics, Initial Public Offering (IPO), Johnson & Johnson (J&J) Backed, Multiple Sclerosis (MS) Pipeline, Phase II Trial, PIPE-307

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.

Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal

1 year ago talkbio0Tagged Amylyx, Amyotrophic Lateral Sclerosis, Clinical Trials, Failure (biologic function), Market, Phase III PHOENIX Study, Placebos, Relyvrio, Statistical Significance, Withdraw (activity)

Amylyx, Relyvrio, ALS, Failure, Phase III PHOENIX Study, Market Withdrawal, Clinical Trial, Placebo, No Statistical Significance

Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks

1 year ago talkbio0Tagged Accelerated, Antibodies, Bispecific, Approved, BeiGene, Brukinsa, Chimeric Antigen Receptor T-cells, Clinical Trials, Combined Modality Therapy, competition, Disease Progression, Gazyva, Lymphoma, Follicular, obinutuzumab, ORR, Overall response rate, Rosewood, Toxicity aspects, United States Food and Drug Administration, zanubrutinib

Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

1 year ago talkbio0Tagged Accelerated, Approved, broadest label, Brukinsa, BTK Inhibitor, CHMP, Chronic lymphoma, Combined Modality Therapy, Lymphoma, Follicular, obinutuzumab, Oregon (geographic location), Overall response rate, Phase 2 Clinical Trials, Phase II ROSEWOOD trial, Recommendation, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Relapsing course, Rosewood, United States Food and Drug Administration

Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR

Merck KGaA Abandons BTK Inhibitor Program, Emphasizes External Innovation

1 year ago talkbio0Tagged BTK Inhibitor, Clinical Trials, evobrutinib, External innovation strategy, Failed, Merck KGaA

Merck KGaA, BTK inhibitor, Evobrutinib, External innovation strategy, Failed clinical trials

AstraZeneca Commits £650M Expansion for UK Vaccine Hub and Research Campus

1 year ago talkbio0Tagged AstraZeneca, Cambridge/, Economic Growth, England, Environment, Government support, Investments, Life sciences sector, Occupations, operationally, pandemic preparedness, public health protection, Renewable Energy, research, Research and Development, Speke/ Liverpool, Surgical construction, Taxes, UK vaccine

AstraZeneca, £650 million investment, UK vaccine hub, Speke/ Liverpool, Renewable energy, Operationally net-zero facility, Research and Development (R&D) campus, Cambridge/ England, Job creation, Pandemic preparedness, Public health protection, Economic growth, Government support, Tax environment, Life sciences sector