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Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said last month. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation that instead allows compounders to volunteer for agency oversight. Read More
Drugmakers have 13 months to revamp how they track drugs after President Barack Obama signed into law a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
UK-based Egalet has signed a licensing agreement with Shionogi to develop and market oral abuse-deterrent hydrocodone opioid products, with Shionogi footing the bill for all development costs and holding on to global marketing rights. Read More
The FDA has agreed to review Purdue Pharma's NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Positive results from the first long-term trial of evolocumab, Amgen’s next-generation heart drug, are heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More