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Just days after the Trans-Pacific Partnership pact cut exclusivity protections for drugmakers outside the U.S., a proposal that would extend a waiver allowing poor countries to ignore drug patent laws is raising more ire. Read More
The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility. Read More
The UK’s healthcare costs regulator Tuesday launched the Office of Market Access, providing drugmakers with a dedicated team to address queries about cost-benefit assessments. Read More
The FDA is seeking feedback on the chemistry, manufacturing and controls information that it wants drugmakers to include in INDs for gene therapies containing microbial vectors. Read More