Pharmacologic Substance
Tremfya Phase III Maintenance Study Results Presented by J&J for Ulcerative Colitis Treatment
J&J, Johnson & Johnson, Tremfya, guselkumab, Phase III trial, maintenance study, ulcerative colitis, inflammatory bowel disease, treatment, efficacy, safety, remission.
EU Upholds Approval of PTC Therapeutics’ Duchenne Muscular Dystrophy Treatment
EU, PTC Therapeutics, Duchenne Muscular Dystrophy (DMD), treatment, approval, rejection, committee.
Translarna by PTC Therapeutics: Awaiting Another EU Regulatory Review for Muscular Dystrophy Treatment
PTC Therapeutics, Translarna, muscular dystrophy, EU review, regulatory approval, Duchenne muscular dystrophy (DMD), European Medicines Agency (EMA), ataluren, rare disease treatment.
AstraZeneca Ordered to Pay Pfizer Over $107 Million in Tagrisso Patent Infringement Case
AstraZeneca, Pfizer, Tagrisso, patent infringement, jury verdict, damages, lung cancer treatment
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
Moderna Secures Victory in EU Patent Dispute with Pfizer-BioNTech over COVID-19 Vaccine
Moderna, Pfizer, BioNTech, EU, patent dispute, COVID-19 vaccine, mRNA technology, European Patent Office (EPO), intellectual property rights, pharmaceutical industry.
Rapport Neuroscience Biotech Aims for Expansion with Initial Public Offering
Rapport, neuroscience, biotech, IPO, clinical-stage, expansion, pharmaceuticals, neurological disorders, mental health
AstraZeneca Invests $1.5 Billion in Singapore for State-of-the-art Antibody-Drug Conjugate Manufacturing Facility
AstraZeneca, Singapore, investment, antibody-drug conjugate (ADC), manufacturing facility, end-to-end production, biotechnology, pharmaceuticals, cancer treatment, innovation, global expansion.
EMA Recommends Halt on Preterm Birth Medications Due to Safety Concerns
European Medicines Agency (EMA), safety committee, preterm birth drugs, suspension, safety concerns, pregnancy, fetal development.
WHO Approval for Takeda’s Dengue Vaccine: A Breakthrough in Global Health
WHO, Takeda, dengue vaccine, prequalification, global health, regulatory tracker, breakthrough, approval.