PERSON
Eli Lilly’s State Law Attempt to Halt Florida Compounding Pharmacy’s Tirzepatide Sales Dismissed
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
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
BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)
FDA Oncology Chief Emphasizes Equitable Standards in Confirmatory Trial Rejections at AACR24
AACR24, FDA Oncology Chief, Richard Pazdur, Confirmatory Trial Rejection, Level Playing Field, Project
Sanofi Settles 4,000 Zantac Cancer Lawsuits, Faces Delaware Claims
Sanofi, Zantac, Cancer Lawsuits, Settlement, Delaware Claims, 4/000 Lawsuits, Delaware Superior Court, Daubert Ruling
Experts Commend Amylyx for Withdrawing ALS Drug Relyvrio Following Trial Failure
Amylyx, Relyvrio, ALS drug, Trial failure, Market withdrawal, Promise kept
Merck KGaA Partners with AI Techbio Caris Discovery for ADC Discovery, Up to $1.4 Billion in Milestones
Merck KGaA, AI techbio, Caris Discovery, Antibody-Drug Conjugates (ADC), $1.4 billion milestones, ADC discovery deal
Delaware Judge Rules in Favor of Roivant Subsidiary Arbutus in COVID-19 Vaccine Patent Dispute with Moderna
Moderna, Arbutus Biopharma, Roivant Sciences, COVID-19 vaccine, Patent infringement, Judge Mitchell Goldberg, Lipid nanoparticles (LNP), Claim construction order
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US
Genmab Acquires ProfoundBio for $1.8 Billion to Challenge AbbVie’s Elahere in ADC Market
Genmab, ProfoundBio, $1.8 billion acquisition, Antibody Drug Conjugates (ADCs), Competition with AbbVie’s Elahere, Rinatabart sesutecan (Rina-S), Folate Receptor Alpha (FRα), Midphase clinical trials