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Drug manufacturers are pressing for faster approval of antimicrobial susceptibility tests, because without them, physicians are reluctant to prescribe new antibiotic drugs, even when they have received FDA approval. Read More
The FDA has rejected Pain Therapeutics extended-release oxycodone Remoxy for the third time, issuing a complete response letter that hinges on the agency’s request for new studies to substantiate the product’s abuse-deterrence label claims. Read More
The UK’s price watchdog has recommended reimbursement for Alexion Pharma’s Strensiq to treat perinatal- and infantile-onset hypophosphatasia and Gilead’s Epclusa to block the spread of hepatitis C virus genotypes to new cells, provided the companies discount the prices. Read More
Earlier this summer the FDA recommended a five-point scale to rate topical patch adhesion for drugmakers submitting abbreviated new drug applications (ANDA). However, the recommendations have only raised more questions. Read More