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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. Read More
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. Read More
Regeneron Pharmaceuticals and CytomX Therapeutics have partnered to develop bispecific cancer drugs in a deal whose value could exceed $2 billion. Read More
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. Read More
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. Read More
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 of new treatments for combating drug-resistant pathogens. Read More