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“I thought the efficacy data was very strong,” said committee member Dean Follmann, assistant director for biostatistics at the National Institute of Allergy and Infectious Diseases. “When we do a pooled analysis to compare it to primaquine we see they’re very similar.” Read More
The surcharge on pharmaceutical manufacturers and wholesale distributors will “punish those companies for the opioid epidemic, the roots of which are… Read More
The Healthcare Distribution Alliance has sued the state of New York over a new law that imposes a $600 million surcharge on opioid manufacturers and distributors. Read More
Citing favorable clinical trial data, an FDA advisory committee voted Thursday in favor of the safety and efficacy of GlaxoSmithKline’s new drug application for tafenoquine indicated for radical cure and prevention of relapse of malaria. Read More
Materials at the booth indicated that Crenolanib is safe and effective for AML treatment when combined “with chemotherapy at full doses,” despite a lack of safety and efficacy data. Read More
Cosmo Technologies filed a second lawsuit against Actavis alleging the drugmaker infringed upon Cosmo’s patent with its newly approved generic for the colitis drug Uceris (budesonide). Read More
The FDA issued an untitled letter to Arog Pharmaceuticals for promotional claims it made on a display booth and a webpage about an unapproved investigational new drug’s safety and efficacy. Read More
The Justice Department issued a final rule Wednesday that will strengthen the Drug Enforcement Administration’s ability to crack down on drug diversion. Read More
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work with product sponsors to help make the development and approval of innovative gene therapies more efficient. Read More