The US Food and Drug Administration has approved a new use for the Gilead Sciences, Inc antiretroviral drug, Truvada (emtricitabine and tenofovir disoproxil fumarate), for use in individuals who are at high risk of HIV infection.
Some 300 clinical trials are underway in Europe testing prospective cell, gene and tissue-engineered therapies. Known as advanced therapy medicinal products (ATMPs), these medicines are being investigated for a broad range of diseases- from macular degeneration to Parkinson’s disease.
GlaxoSmithKline Plc announced that it has withdrawn an application from the US Food and Drug Administration for a new indication for its marketed cancer drug, Tykerb (lapatinib), a kinase inhibitor.
The US Food and Drug Administration has approved the first genetic test that will detect whether patients with colorectal cancer are eligible for treatment with the antibody drug, Erbitux (cetuximab). The test was developed by Qiagen NV.
The US Food and Drug Administration has approved the first DNA test to help healthcare professionals evaluate the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
The US Food and Drug Administration has approved the first over-the-counter, self-administered test to detect the presence of antibodies to the human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).
GlaxoSmithKline Plc said that it will pay $3 billion to settle several criminal and civil cases brought against it by the US government, several states and the District of Columbia relating to past sales and marketing practices, including sales of Avandia.
The steep rise in pharmaceutical prices over recent decades has finally come to a halt and prices are now showing signs of declining at an accelerating pace. As a result, Big Pharma is asking European policy makers to do something about it.
The erosion of pharmaceutical prices in Europe has accelerated with the debt crisis and prices now look set to decline by 5% or more, according to Andrew Witty, president of the European pharmaceutical industry federation, EFPIA, and chief executive of GlaxoSmithKline Plc.
An antibiotic from AstraZeneca Plc is one of four new medicines to be recommended for marketing in Europe by the EMA’s Committee for Medicinal Products for Human Use. The drug, Zinforo, is a cephalosporin antibiotic.