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.
In an unusual public rebuke, the European Medicines Agency has cited Roche for deficiencies in its medicine-safety reporting system. It has given the company until 27 June to submit a comprehensive plan for dealing with outstanding cases.
The US Food and Drug Administration has approved a new combination vaccine for infants and children aged six weeks through 18 months for the prevention of two types of meningococcal disease and Haemophilus influenzae type b (Hib disease).
Sanofi SA has announced regulatory filings in both the US and Europe for alemtuzumab (Lemtrada) to treat relapsing multiple sclerosis. The monoclonal antibody is already approved in the US for second-line CLL and trades as Campath.