Archive for November 2022

In response to the nationwide shortage of the antibiotic amoxicillin, the FDA yesterday released guidance that allows compounders to produce beta-lactam antibiotic liquid suspensions to help satisfy the increased demand. Source: Drug Industry Daily

In a win for Pfizer, the Patent Trial and Appeal Board (PTAB) has declared that EtranaDez (etranacogene dezaparvovec), CSL Behring’s investigational gene therapy developed by uniQure for hemophilia B, isn’t unique at all, but merely a tweak of Pfizer’s patented method to increase clotting factor IX with adenovirus-delivered genetic codes. Source: Drug Industry Daily

Lysogene’s investigational gene therapy LYS-SAF302 preserved cognitive function and brain volume in a small set of infants with a devastating type of childhood dementia, mucopolysaccharidosis Type IIIA (MPS IIIA). Source: Drug Industry Daily

Merck is making a sizable investment in expanding its hematology portfolio with the purchase of Imago BioSciences for $1.35 billion. Source: Drug Industry Daily

The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Source: Drug Industry Daily

Regeneron Pharmaceuticals and CytomX Therapeutics have partnered to develop bispecific cancer drugs in a deal whose value could exceed $2 billion. Source: Drug Industry Daily

The World Health Organization (WHO) is working on an international pandemic response accord that would, in part, require pharmaceutical companies to publicly disclose prices or deals for any of their products that might be used in future health emergencies. Source: Drug Industry Daily

While accelerated approval (AA) is a valuable and appropriate path for many promising drugs, for others — particularly those that don’t finish or even start confirmatory trials after they win approval — it’s a thorn in the FDA’s side. Source: Drug Industry Daily

Lupin has again run afoul of the FDA, drawing a Form 483 over deficiencies observed at its injectable drug manufacturing plant in Nagpur, Maharashtra, India, following a pre-approval inspection conducted from Oct. 17 to 29. Source: Drug Industry Daily

The FDA has approved Eli Lilly’s Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar insulin on the U.S. market. Source: Drug Industry Daily