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Massachusetts last week became the first state to ban Zogenix’s controversial painkiller Zohydro, a move that could lead other states to follow suit. Read More
The FDA Friday approved Janssen Pharmaceuticals’ Topamax for the prevention of migraines in adolescents, the first such drug for this age group. Read More
Drugmakers seeking certification that their products comply with the European Pharmacopoeia will soon face a two-step process for having their applications approved by the European Directorate for the Quality of Medicines & HealthCare. Read More
An FDA proposal to only allow stool for fecal matter transplants (FMT) from donors known to patients or their physicians has come under heavy fire from critics who argue it will actually make the procedure more risky and shut down stool banks. Read More
The European Medicines Agency approved a new, time-saving formulation for Roche’s MabThera Friday, positive news for the Swiss drugmaker as it tries to recoup the loss of European patent protection for its blockbuster cancer drug. 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 UK’s health cost-benefit watchdog is developing new “burden of illness” and “societal impact” measurements to use when assessing new drugs for government reimbursement. 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
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More