PERSON – Page 69

Eli Lilly Anticipates Zepbound Label Expansion Following Positive Phase III Sleep Apnea Study Results

2 years ago talkbio0Tagged Eli, Eli Lilly, expansion, Identifier, Improvement, Phase III Sleep Apnea Study, Sleep Apnea, Obstructive, SURMOUNT-OSA, Symptoms, Zepbound

Eli Lilly, Zepbound (tirzepatide), Phase III Sleep Apnea Study, SURMOUNT-OSA, Obstructive Sleep Apnea (OSA), Label Expansion, Fast Track Designation, Symptom Improvement

Barinthus Bio’s HPV Immunotherapy Fails to Demonstrate Statistically Significant Efficacy in Early Study

2 years ago talkbio0Tagged Barinthus, Bio, Effectiveness, HPV immunotherapy, underwhelming, VTP-200

Barinthus Bio, HPV immunotherapy, VTP-200, early study, underwhelming results, efficacy

Vertex Initiates FDA Rolling Review for Non-Opioid Pain Medication Suzetrigine (VX-548)

2 years ago talkbio0Tagged Acute onset pain, Non-opioid painkiller, Rolling Review, Suzetrigine, United States Food and Drug Administration, VX-548

Vertex Pharmaceuticals, Suzetrigine (VX-548), Non-opioid painkiller, FDA rolling review, Acute pain

Eli Lilly’s Zepbound Shows Promising Results in Reducing Sleep Apnea Severity in Pivotal Trials

2 years ago talkbio0Tagged Continuous Positive Airway Pressure, Eli, Eli Lilly, Glucagon-Like Peptide-1 Receptor, Obesity, Sleep Apnea, Obstructive, tirzepatide, trials, Weight Loss, Zepbound

Eli Lilly, Zepbound, Sleep Apnea, Obstructive Sleep Apnea (OSA), Pivotal Trials, Obesity, GLP-1 Receptor Agonist, Tirzepatide, CPAP, Weight Loss

Detailed PHOENIX Study Reveals Relyvrio’s Failure in ALS Treatment

2 years ago talkbio0Tagged Amylyx, Amyotrophic Lateral Sclerosis, Clinical Research, Clinical Trials, Failure (biologic function), Phoenix Pharmaceuticals, Relyvrio

Relyvrio, PHOENIX study, Amyotrophic Lateral Sclerosis (ALS), Trial failure, Amylyx Pharmaceuticals

CMS to Increase Reimbursement for New Sickle Cell Gene Therapies through Outcomes-Based Agreements

2 years ago talkbio0Tagged Administrative action, Burden, Casgevy, Cells, Centers for Medicaid and Medicare (CMS) Pnl, Central, CGT, Equitable Access, Fertility, Grail, Increased, Lyfgenia, Medicaid Access, Medicare & Medicaid Services, OBAs, Outcomes-Based Agreements, Reimbursement, sickle cell gene therapies

CMS (Centers for Medicare & Medicaid Services), Sickle Cell Gene Therapies, Increased Reimbursement, Outcomes-Based Agreements (OBAs), Cell and Gene Therapy (CGT) Access Model, Medicaid Access, Casgevy, Lyfgenia, Fertility Preservation Services, Equitable Access, Administrative Burden Reduction

Boehringer Ingelheim Leverages Late-Stage Pipeline for 25 New Launches over the Next Decade

2 years ago talkbio0Tagged Administration occupational activities, approvals, boehringer ingelheim, Decade, expansion, Heart failure, Jardiance, late-stage pipeline, launches, pipeline, reshuffle

Boehringer Ingelheim, Late-stage pipeline, 25 new launches, Decade, Jardiance, Heart failure approvals, Ofev, Pipeline expansion, Management reshuffle

Eli Lilly’s State Law Attempt to Halt Florida Compounding Pharmacy’s Tirzepatide Sales Dismissed

2 years ago talkbio0Tagged Cosmetic Act, eli lilly, FDCA, Florida compounding pharmacy, Frivolous lawsuits, Judge Roy Altman, Mounjaro/ Zepbound, RXCompoundStore.com, tirzepatide

Eli Lilly, Florida compounding pharmacy, RXCompoundStore.com, Tirzepatide (Mounjaro/ Zepbound), Judge Roy Altman, Federal Food/ Drug/ and Cosmetic Act (FDCA), Frivolous lawsuits

US Drug Shortages Hit Record High Since 2001: ASHP Report

2 years ago talkbio0Tagged ASHP, Attention deficit hyperactivity disorder, Biden administration, Central Nervous System Stimulants, Chemotherapy Drugs Adminstered, controlled substance, Defense Production Act, DPA, Drug Enforcement Administration, Drug shortages, hormone agents, Hospitals, Incentives, intravenous fluids, Microbicides, Quality concerns, Record high, American Society of Health-System Pharmacists, shortage, Supply Chain Resilience, White House Council

Drug shortages, Record high, American Society of Health-System Pharmacists (ASHP), 323 drugs in shortage, Chemotherapy drugs, ADHD therapies, Central nervous system stimulants, Antimicrobials, Hormone agents, Intravenous fluids, Drug Enforcement Administration (DEA), Biden administration, White House Council on Supply Chain Resilience, Defense Production Act (DPA), Incentives for hospitals, Quality concerns, Controlled substances

FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS

2 years ago talkbio0Tagged Agreement, Amyotrophic Lateral Sclerosis, BrainStorm Cell Therapeutics, Early-stage, NurOwn, SPA, Special Protocol Assessment, Trial Phase 3B, United States Food and Drug Administration

BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)