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A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
The FDA has withdrawn at least 10 draft guidances for drugmakers published before the end of 2013 because they had become outdated or were superseded by higher agency priorities. Read More
After nearly four years of litigation, DaVita Healthcare Partners agreed Monday to pay up to $495 million to resolve a whistleblower lawsuit accusing the kidney dialysis provider of wasting drugs in exchange for sizable Medicare and Medicaid reimbursements. Read More
Manufacturers must submit all NDA, ANDAs, BLAs and drug master files electronically by May 15, 2017, and all commercial INDs one year later, under an FDA final guidance. Read More
Sponsors of INDs, NDAs, ANDAs and supplemental applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
The International Society for Pharmaceutical Engineering is developing a tool to help manufacturers locate gaps in production and quality systems, with the aim of averting shortages in the international drug supply. Read More
Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials. Read More