Archive for March 2022
DOJ Begins Investigation Into Widespread Counterfeit HIV Meds Trafficking Scheme
The Department of Justice (DOJ) is reportedly investigating a large prescription drug-trafficking network that allegedly has and is selling hundreds of millions of dollars of counterfeit HIV medications. Source: Drug Industry Daily
Read MoreAkebia’s Vadadustat Receives FDA Complete Response Letter
Akebia Therapeutics will have to conduct a new clinical trial if it wants to move its kidney disease drug vadadustat forward, the FDA said in a Complete Response Letter (CRL) denying approval for the investigational drug. Source: Drug Industry Daily
Read MoreClovis’ Rubraca Will Advance on Positive Phase 3 Topline Numbers
Clovis Oncology’s Rubraca (Rucaparib) nearly halved the risk of disease progression in women with newly diagnosed advanced ovarian cancer following treatment combined with platinum-based chemotherapy. Source: Drug Industry Daily
Read MoreFDA Details COVID-19 Booster Dose Immunogenicity Studies in Final Guidance
The FDA included detailed recommendations for booster shot studies in a final guidance on Emergency Use Authorizations (EUAs) for COVID-19 vaccines released yesterday. Source: Drug Industry Daily
Read MoreAbbVie, Teva Settle Opioid Cases With Florida for Almost $330 Million
AbbVie’s Allergan subsidiary and Teva Pharmaceuticals have agreed to pay nearly $330 million to settle claims that they played a role in the opioid abuse and overdose crisis in Florida. Source: Drug Industry Daily
Read MoreHouse Passes Bill to Cap Insulin Prices
In a 232-to-193 vote yesterday, the House passed a bill that would cap out-of-pocket insulin costs at $35 per month. Source: Drug Industry Daily
Read MoreFDA Advisory Panel Votes Down Amylyx Pharmaceuticals’ ALS Drug Candidate
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday declined by a vote of 6-4 to recommend approval of Amylyx Pharmaceuticals’ AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Source: Drug Industry Daily
Read MoreFDA Officials Look to Set the Record Straight on Definition of ‘Digital Biomarker’
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Source: Drug Industry Daily
Read MoreBiogen Submits Four-Year Phase 4 Study Protocol for FDA Approval
Biogen will complete its FDA-mandated phase 4 Aduhelm study in four years — less than half the time the agency allotted when it granted accelerated approved for the controversial antiamyloid antibody last year. Source: Drug Industry Daily
Read MoreRoche’s Investigational Drug Tiragolumab Fails in Phase 3 Lung Cancer Study
Roche has said its investigational monoclonal antibody, tiragolumab, combined with Tecentriq (atezolizumab) and chemotherapy did not meet the endpoints of overall survival or progression-free survival in a phase 3 study in patients with extensive-stage small-cell lung cancer (ES-SCLC). Source: Drug Industry Daily
Read More