GPE – Page 22 – Talk Bio

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

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

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

1 year 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

1 year 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