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.…
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…
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:…
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
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 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…
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…
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…
After the challenges of global in-person facility inspections throughout the pandemic, the FDA is at the start of “a return to a steady state,” of onsite work, said an FDA…
More than 150 industry organizations and drugmakers have submitted a letter to Congressional leaders urging passage of the Pasteur Act, a languishing bill first introduced in 2020 to incentivize development…