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FDA Rejects Abeona’s PZ-CEL Topical Gene Therapy, Delaying Further Progress
Abeona, PZ-CEL, topical gene therapy, FDA, rejection, delay, clinical trials, EB-101, Epidermolysis Bullosa
FDA Issues Complete Response Letter to Abeona’s Cell Therapy for Rare Skin Disease
FDA, Complete Response Letter (CRL), Abeona, cell therapy, rare skin disease, Epidermolysis Bullosa (EB)
Ipsen and Skyhawk Therapeutics Join Forces in a $1.8 Billion Deal to Advance RNA Modulator Research
Ipsen, Skyhawk Therapeutics, RNA modulators, drug discovery, partnership, $1.8 billion, biopharmaceutical, R&D, therapeutic development
Eli Lilly Anticipates Zepbound Label Expansion Following Positive Phase III Sleep Apnea Study Results
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
Barinthus Bio, HPV immunotherapy, VTP-200, early study, underwhelming results, efficacy
Vertex Initiates FDA Rolling Review for Non-Opioid Pain Medication Suzetrigine (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
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
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
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
Boehringer Ingelheim, Late-stage pipeline, 25 new launches, Decade, Jardiance, Heart failure approvals, Ofev, Pipeline expansion, Management reshuffle