Governmental or Regulatory Activity
Erasca Pivots Strategy, Secures $160M and Licenses Chinese Cancer Drugs Amidst Workforce Restructuring
Erasca, pipeline, workforce reduction, licensing, cancer drugs, China, $160M, strategic shift
Ex-Pharmaceutical Executive Receives Probation in Antitrust Violation Case
Pharmaceutical industry, antitrust violation, price-fixing, Sandoz, executive, sentencing, probation
ICER Raises Concerns Over Uncertainties in Lykos MDMA Clinical Trials Ahead of FDA Advisory Committee Meeting
ICER, Lykos, MDMA, clinical trials, uncertainties, FDA, AdComm, advisory committee meeting
FDA Imposes Three-Month Delay on Ascendis’ Hypoparathyroidism Treatment
Ascendis Pharma, hypoparathyroidism, FDA, drug approval, delay, three-month setback, regulatory hurdle, treatment, endocrine disorder.
FDA Approves Apple Watch’s Afib-Tracking App for Clinical Research
Apple Watch, afib-tracking app, FDA certification, clinical studies, heart health, medical technology, wearable devices, digital health.
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.
FDA Approval Milestones: X4 Pharmaceuticals, Pfizer, and Genmab Secure Nods for Rare Disease and Cervical Cancer Treatments
FDA, X4 Pharmaceuticals, Pfizer, Genmab, rare disease, cervical cancer, drug approval, treatment, healthcare, biotechnology.
Medicare Coverage Gap Linked to Reduced Prescription Rates for GLP-1 Weight Loss Drugs
GLP-1 drugs, Medicare coverage gap, Lower prescription rates, Obesity treatment, Semaglutide (Wegovy), Tirzepatide (Mounjaro), Liraglutide (Saxenda), Healthcare costs, Truveta study
Medicare Partially Covers Weight Loss Drugs Amidst High Price Concerns and Future Negotiation Prospects
Medicare, Obesity drugs, Wegovy, Semaglutide, Price negotiation, Affordability, Accessibility, Premium increases, Utilization management