GPE – Page 31 – Talk Bio

Walgreens Takes $6 Billion Hit from VillageMD Investment Amid Strategic Review

1 year ago talkbio0Tagged Clinic, Cost Savings Plan, Investment Value Decline, Quarter 2, strategic review, VillageMD, Walgreens, Write-down

Walgreens, VillageMD, Quarter 2, $6 billion loss, Write-down, Investment Value Decline, Strategic Review, Cost Savings Plan, Underperforming Clinics Closure

FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

1 year ago talkbio0Tagged Adolescent (age group), Adults/, Approved, Condoms, Male, COVID19 (disease), Emergency Use Authorization, Half-Life Extended Monoclonal Antibody, immune compromise, Immunocompromised Host, Invivyd, Moderate (severity modifier), Pemgarda, pemivibart, Pre-Exposure Prophylaxis, Prophylactic treatment, Severe (severity modifier), United States Food and Drug Administration, VYD222

Invivyd, Pemgarda (pemivibart; formerly VYD222), Half-Life Extended Monoclonal Antibody, COVID-19 Prophylactic, Immunocompromised Patients, Emergency Use Authorization (EUA), FDA Approval, Moderate to Severe Immune Compromise, Pre-exposure Prophylaxis (Prevention) of COVID-19 in Adults/ Adolescents

Orchard Therapeutics Sets $4.25 Million Price Tag for Leukodystrophy Gene Therapy

1 year ago talkbio0Tagged Grail, Lenmeldy, Leukodystropy, Orchard, Prices

Orchard Therapeutics, Leukodystropy, Gene Therapy, Lenmeldy, $4.25 million US price tag

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

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 Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment

1 year ago talkbio0Tagged Accelerated clearance, Adult, Antibody-Drug, Approved, Madrigal Pharmaceuticals, metabolic dysfunction-associated steatohepatitis, moderate-to-advanced liver fibrosis, Non-cirrhotic, resmetirom, Rezdiffra, United States Food and Drug Administration

FDA approval, Madrigal Pharmaceuticals, Rezdiffra (resmetirom), Metabolic dysfunction-associated steatohepatitis (MASH), Accelerated clearance, Adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis

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

2 years 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

Roche and Alnylam’s Hypertension Hopeful Zilebesiran Shows Promising Results in Combination Therapy Trial

2 years ago talkbio0Tagged Alnylam, Angiotensinogen, Combined Modality Therapy, control of blood pressure, Hypertensive disease, Intravascular systolic:Pressure:Point in time:Arterial system:Quantitative, RNA Interference, Roche (company), Safety, Zilebesiran

Roche, Alnylam, Zilebesiran, Hypertension, Combination Therapy, Phase 2 Trial, Blood Pressure Control, AngioTensinogen (AGT), RNA Interference (RNAi) Therapeutic, Significant Reductions in Systolic Blood Pressure, Encouraging Safety Profile

Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

2 years ago talkbio0Tagged amgen, Approved, Biosimilars, Cancer-related skeletal events, denosumab, interchangeable, Jubbonti, Osteoporosis, patent litigation, Prolia, sandoz, Secondary malignant neoplasm of bone, United States Food and Drug Administration, Wyost, Xgeva

Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation