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The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday. 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
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. 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
Novo Nordisk has aced the first Phase III trial of its hemophilia candidate, giving the drugmaker a needed boost in a tight race with two other competitors vying to be first to market with a new therapy targeting a disease the FDA says demands industry attention. Read More
The Arkansas Supreme Court reversed a $1.2 billion verdict against Johnson & Johnson concerning its marketing practices for the antipsychotic Risperdal, giving the pharma giant another crucial legal victory. Read More