Temporal Concept – Page 33

Acorda Therapeutics Concludes $185M Asset Sale with Merz amid Bankruptcy Filing Following Disappointing Sales

1 year ago talkbio0Tagged Acorda, asset, Bankruptcy filing, Biogen returns, Declining sales, ex-US, Fampyra, Generic competition, Merz, Multiple Sclerosis drug, Neurological diseases, year

Acorda Therapeutics, $185M asset sale, Merz, Bankruptcy filing, Years of disappointing sales, Multiple Sclerosis drug Fampyra, Biogen returns ex-US rights, Generic competition, Declining sales, Neurological diseases

Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges

1 year ago talkbio0Tagged Bankruptcy, Biological Factors, Chapter 11, Assets Sale, development aspects, Eiger, Infrequent, Metabolic Disease Therapy, Operational Wind Down

Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development

AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD

1 year ago talkbio0Tagged Approved, AstraZeneca, Autoimmune Diseases, dosing, Infrequent, Long-acting C5 complement inhibitor, Neuromyelitis Optica, Rating (action), ravulizumab-cwvz, Reduced, Relapse, Ultomiris, United States Food and Drug Administration, With frequency

AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency

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

Takeda’s $5.2B Ariad Deal Yields Label Expansion for Iclusig in Rare Leukemia

1 year ago talkbio0Tagged 5.2B, Ariad, expansion, Iclusig, Infrequent, Labels (device), leukemia, Takeda

Takeda, Ariad, $5.2B deal, Iclusig, Label expansion, Rare form of leukemia

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

FDA Grants First Approval for Orchard Therapeutics’ Gene Therapy Lenmeldy in Treating Rare Pediatric Neuron Disease

1 year ago talkbio0Tagged Approved, Autologous Gene Therapy, Infantile/, Juvenile, Lenmeldy, Leukodystrophy, Metachromatic, Orchard, Pre-Symptomatic Late, Rare Pediatric Disease, United States Food and Drug Administration

Orchard Therapeutics, Lenmeldy, FDA Approval, Metachromatic Leukodystrophy (MLD), Rare Pediatric Disease, Autologous Gene Therapy, Pre-Symptomatic Late Infantile/ Early Juvenile Patients

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.