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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
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 assistant commissioner in the keynote address at the WCG-FDAnews’ 17th Annual Inspections Summit in Washington, D.C., on Thursday. Read More
The company believes the drug will inhibit C5 in patients with certain complement-mediated diseases. There is currently no cure for myasthenia gravis. Read More
Aarkish Pharmaceuticals received a nine-observation Form 483 for missing records and other quality lapses observed during an inspection of its Fairfield, N.J., facility. Read More
A federal appeals court sided with AbbVie’s Pharmacyclics and Johnson & Johnson’s Janssen Biotech this week, affirming that a generic version of the blockbuster cancer drug Imbruvica (ibrutinib) infringes their patents. Read More
Sellas Life Sciences is amending the statistical analysis in an ongoing phase 3 trial for acute myeloid leukemia after a preliminary data review found that patients enrolled were living twice as long as originally projected. Read More