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Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and detailed warning letter that cautioned the company against sharing equipment between the two operations. Read More
AstraZeneca’s blockbuster Fasenra (benralizumab) has stumbled in its quest to become a therapy for eosinophilic esophagitis, failing to hit the clinical target of its dual-primary endpoints in a critical phase 3 trial. Read More
The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness, safety and public health priority from consideration of the price of medicines and their cost-effectiveness. Read More
On the heels of a recent FDA write-up, another Catalent facility drew a Form 483 from the agency for multiple quality lapses following an inspection of its Brussels, Belgium, plant. Read More
The Centers for Medicare and Medicaid Services (CMS) should require clinical trial participation of patients seeking coverage for many new drugs, particularly those that have accelerated approval. Read More
Pharma giant Bayer has won the top spot at the inaugural WCG Innovation Challenge for its efforts to make the charitable donation of unused trial kits and supplies an industrywide practice. Read More
The Health Resources & Services Administration (HRSA) has warned Merck that it could get slapped with fines for refusing to grant 340B discounts to hospitals and clinics that participate in the program. Read More