Governmental or Regulatory Activity
Johnson & Johnson to Appeal $150 Million Verdict in HIV Meds Off-Label Marketing Case
Johnson & Johnson, HIV Meds, Off-Label Marketing, Appeal, $150 Million Verdict
FDA Advisory Panel Rejects Lykos’ MDMA Treatment for PTSD Despite Promising Results
MDMA, PTSD, FDA, Lykos Therapeutics, Psychopharmacologic Drugs Advisory Committee, psychedelic therapy
Galapagos Partners with Adaptimmune for $665M T-Cell Therapy Collaboration
Galapagos, Adaptimmune, T-cell therapy, MAGE-A4 TCR, Uza-cel, Biobucks collaboration, Licensing deal, Financing, Next-generation therapy
Sen. Wyden Scrutinizes Pfizer’s Tax Rate Amidst Ongoing Investigation
Sen. Wyden, Pfizer, tax rate, investigation, corporate taxation, tax avoidance, pharmaceutical industry, financial transparency
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.