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.
The US Food and Drug Administration has approved a new personalised medicine for HER2 positive breast cancer from Roche. But supplies of the drug will be limited pending the resolution of a manufacturing problem, according to the agency.
The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) for the management of postherpetic neuralgia in adults. This follows the drug’s approval in the US in 2011 for restless legs syndrome.
Ridaforolimus, an investigational treatment for metastatic soft tissue or bone sarcoma, has been turned down by the US Food and Drug Administration. The sponsor, Merck & Co Inc, announced receipt of a complete response letter on 5 June 2012.
The European Medicines Agency (EMA) has launched a new public website that contains information about suspected adverse events relating to medicines that have been authorised for sale in the European Economic Area (EEA).