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,…
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.…
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. Source: Drug Industry…
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…
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 FDA spelled out its latest thinking on demonstrating bioequivalence for topical generic drugs in four separate draft guidances released on Friday. Source: Drug Industry Daily
The FDA has granted Regeneron an additional six months of pediatric exclusivity for its intraocular injection Eylea (aflibercept) as a treatment for preterm infants with retinopathy of prematurity (ROP). Source:…
The FDA says it will push back its deadline for enforcing a statute that limits a compounding pharmacy’s out-of-state sales to 5 percent of its business if its state has…
Both clinical and surrogate endpoints are acceptable targets for trials investigating gene therapies (GT) for neurodegenerative diseases, according to finalized FDA guidance on developing these products. Source: Drug Industry Daily
Takeda, Zedira and Dr. Falk Pharma inked a collaboration and licensing agreement to develop TAK-227, an investigational therapy for patients with celiac disease, an autoimmune disorder characterized by inability to…