Simplifying Global Compliance
An EU panel of drug reviewers Friday urged approval of Boehringer Ingelheim and Eli Lilly’s diabetes drug empagliflozin, lauding the candidate just two weeks after the FDA turned it down. Read More
The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday. Read More
Of the approximately 7.7 million new cases of dementia each year, Piramal says, about 60 to 80 percent are Alzheimer’s disease. Read More
The goal of the ICMRA would not be to develop identical standards, but to provide the public with “high-level, strategic advocacy” around quality, Hamburg said at a recent conference in London hosted by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA March 12 banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
House Democrats are asking Gilead Sciences to justify the cost of its pricy hepatitis C pill Sovaldi, saying many of their constituents affected by the disease may not be able to afford it. Read More
Efforts by generic drugmakers to initiate patent litigation early by sending premature Paragraph IV certification notices to innovators are prompting the FDA to crack down on the practice, though it’s not yet clear what actions the agency intends to take. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is proposing three rules changes to reduce the amount of information included in physician advertising. Read More
Janssen hopes to submit an NDA for the drug later this year.
The FDA has approved Paladin Therapeutics’ oral drug Impavido to treat leishmaniasis, a tropical disease caused by parasites. Read More
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