US regulators have approved Bayer’s Xofigo as a treatment for prostate cancer, just three months after it was assigned a priority review.
News
Data transparency “a very strange debate” says new Lilly head
The new head of Lilly UK believes that the clinical trial transparency agenda in the UK is a “very strange debate”.
BIO, ViS partner to accelerate paediatrics trials
US trade group the Biotechnology Industry Organization (BIO) has linked up with the ViS Research Institute, a New York-based company specialising in data analytics for clinical-trial planning, to improve the efficiency of paediatric drug-development programmes.
Biosimilar drugs’ global revenues “to hit $2.44B this year”
The world market for biosimilar drugs will reach a value of $2.44 billion for the whole of 2013, representing growth of more than 20% from 2012 and accounting for around 2% of the overall biological drugs market, according to a new study.
Datatrak teams with STAT Research for LatAm markets
US-based eClinical solutions specialist Datatrak International is raising its profile in Latin America by teaming up with local contract research organisation (CRO) STAT Research.
Elan spends $1bn on access to Theravance royalties
Dublin, Ireland-based biotech Elan has hooked up with US group Theravance under a $1-billion deal that gives it access to a portion of royalties from four of the latter’s drugs.
Janssen gets speedy review for Hep C drug
US regulators have agreed to conduct an accelerated review of Janssen Research & Development’s investigational hepatitis C drug simeprevir.
MHRA considers drug sales on planes and trains
UK watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) has this month opened a public consultation on proposals to allow the sale of medicines on planes and trains.
NICE to develop quality standards in public health
The National Institute for Health and Care Excellence has been asked by the government to develop quality standards (QS) in public health, adding to its existing programme of work within health and social care.
Pharma and CCGs: “moving medication back to positivity”
Medication needs to move back to positivity, and the challenge of achieving this represents huge opportunities for the pharmaceutical industry, a recent meeting of the PharmaTimes Directors Club (PDC) has heard.
Pharma bulk-buying “may put patients at risk,” govts warned
Governments which opt for prescription drug bulk purchasing agreements can save taxpayers money but at the risk of reducing patient health by limiting access to optimal medicines, according to new research.
Quintiles raises US$947.4 million in second IPO
Quintiles Transnational made a big splash with its second initial public offering since the company started up in 1982, raising US$947.4 million in an IPO that was substantially larger than the US$789.5 million best-case scenario presented around two weeks earlier.
SMC ‘yes’ for Shire’s ADHD drug Elvanse
Children in Scotland with attention-deficit hyperactivity disorder (ADHD) have gained access to a new treatment option after regulators agreed to fund Shire’s Elvanse on the National Health Service.
Lilly pulls lymphoma drug enzastaurin after Phase III failure
Eli Lilly has suffered a setback in the lab after its lymphoma drug enzastaurin failed to met its survival goals in late-stage trials.
NHS hospital staffing levels dangerous, say nurses
A group of nursing and patient organisations in the UK are warning that staffing levels on a number of hospital wards in the NHS in England are “unsafe”.
