There are almost 800 drugs for rare diseases either in clinical trials or awaiting review by the FDA, according to a new report by the Pharmaceutical Research and Manufacturers of…
AstraZeneca’s COVID-19 vaccine becomes completely ineffective against the Omicron variant by 15 weeks, according to real-world British data released yesterday. Source: Drug Industry Daily
Calliditas Therapeutics’ Tarpeyo (budesonide) has won FDA accelerated approval for reducing a harmful urine protein in adults with a rare kidney disease, primary immunoglobulin A (IgA) nephropathy. Source: Drug Industry…
Stanton, Calif.-based Sanitor Corporation has drawn an FDA warning letter over current good manufacturing practice (cGMP) violations for finished drugs. Source: Drug Industry Daily
Sanofi and GlaxoSmithKline (GSK) said preliminary data from a phase 3 study showed that a booster dose of their experimental COVID-19 shot induces strong immunity but said they won’t release…
Did Gilead Sciences collude with other drug companies to delay its blockbuster HIV pills from reaching the end of their patents? Did the company offer sweet deals to a generic…
After a year of controversy for janus kinase (JAK) inhibitors, the FDA has now greenlighted two JAK inhibitors for inflammatory disease indications that had been delayed for months while the…
A global coalition of regulators has recommended permanent use of the remote inspections of drug manufacturing plants that regulatory bodies began to use during the COVID-19 pandemic. Source: Drug Industry…
President Biden’s pick to become FDA commissioner, Robert Califf, received bipartisan support yesterday during a Senate confirmation hearing in which he comfortably fielded questions from lawmakers. Source: Drug Industry Daily
Australian biotech firm CSL will purchase Swiss pharmaceutical company Vifor Pharma for $11.7 billion in a deal set to close in mid-2022, the companies announced. Source: Drug Industry Daily