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The FDA granted Merck’s new melanoma drug Keytruda accelerated approval and orphan drug status after a clinical trial indicated improved efficacy. Read More
Pharmaceutical companies want to maintain the current exemption on reporting financial support for continuing medical education (CME) programs under the Physician Payment Sunshine Act, a position that is under threat from a new proposed rule. Read More
Both PhRMA and public health advocacy group Pew Charitable Trusts want CMS to account for its delay in publishing one-third of the data that manufacturers must submit on payments to physicians and teaching hospitals. Read More
Teva is clear to market its version of AstraZeneca’s chronic obstructive pulmonary disorder drug Symbicort in the United Kingdom, after the High Court there struck down an AZ indication patent on grounds of obviousness. Read More
Johnson & Johnson is pulling its OTC nausea and vomiting drug domperidone from the UK market following a decision by regulators that the medicine must require a prescription to obtain due to risks of serious cardiac effects. Read More
Starting this month, active substances found only in medicines authorized at the country level in the EU are subject to centralized review of period safety update reports by the European Medicines Agency. Read More
A federal judge has ruled that Par Pharmaceutical’s generic version of the Novartis Alzheimer’s treatment Exelon Patch did not infringe on the brand manufacturer’s patent. Read More