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Republican lawmakers Tuesday blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More
While manufacturers support a strong pharmacovigilance system to ensure patient safety, the proposed costs are a source of concern, “especially in light of the annual saving for the pharmaceutical industry of 145 million euros (US $201 million) that was anticipated in the 2008 European Commission ‘impact assessment,’” a coalition of five trade groups says. Read More
The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More
Members of the U.S. House of Representatives are asking the HHS Inspector General to investigate whether a drug industry-funded organization improperly influenced the FDA’s approval of pain drugs such as Zogenix’s Zohydro ER. Read More
The FDA’s adoption of the U.S. Pharmacopeia’s strict naming rules for drugs with salt-based active ingredients could lead to drug development delays, manufacturers warn. Read More
Global drug giant Pfizer said Tuesday that its Phase III Profile 1014 postmarketing commitment study of anaplastic lymphoma kinase-inhibitor Xalkori met its primary objective of prolonging progression-free survival in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) compared with platinum-based chemotherapy. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
The European Medicines Agency (EMA) on Mar. 11 launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More