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Regulation & Policy
FDA approves genetic test for colorectal cancer
Sunday 8 July 2012
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.
Location
United States
FDA approves new DNA test
Thursday 5 July 2012
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.
Location
United States
FDA approves first home-use HIV test
Tuesday 3 July 2012
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).
Location
United States
GSK to pay $3 billion to US to settle litigation
Monday 2 July 2012
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.
Location
United Kingdom
EFPIA Meeting: Pharma raises concern over drug price erosion
Monday 2 July 2012
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.
Location
Belgium
Witty says pharma price decline speeds up
Wednesday 27 June 2012
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.
Location
Belgium
AZ antibiotic receives positive CHMP opinion
Friday 22 June 2012
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.
Location
United Kingdom
EMA cites deficiencies in safety reporting at Roche
Thursday 21 June 2012
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.
Location
United Kingdom
GSK combination vaccine approved by FDA
Friday 15 June 2012
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).
Location
United States
Sanofi files alemtuzumab in MS
Tuesday 12 June 2012
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.
Location
France
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Recent Appointments
Pascale Witz to head strategic development at Sanofi
Monday May 6 2013
Srinivas Akkaraju joins Sofinnova Ventures
Monday May 6 2013
Vicente Anido nominated to Nicox board
Monday May 6 2013
Jeremy Farrar named director of the Wellcome Trust
Monday May 6 2013
Harry Kirsch becomes CFO at Novartis
Monday May 6 2013