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Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More
The UK’s price watchdog is not recommending reimbursement for Merck’s Keytruda for the treatment of advanced or metastatic lung cancer in patients who have had at least one previous chemotherapy regimen. Read More
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