The US Food and Drug Administration is expected to raise the fees it charges the pharmaceutical industry and other companies for its services in order to pay for a proposed increase in its budget for the fiscal year starting on 1 October.
The US Food and Drug Administration has refused to approve a new indication for Novartis’s meningococcal vaccine, Menveo, which would have extended its use to infants and toddlers. The vaccine is already approved for older age groups.
Shire Plc reported revenue of $4.3 billion in 2011, up by 23%, reflecting strong demand for the attention deficit hyperactivity disorder (ADHD) treatments, Vyvanse and Intuniv. Sales were also helped by a regenerative medicines acquisition.
Zealand Pharma A/S said it is set to receive a $20 million milestone payment from its partner, Sanofi SA, following the successful completion of the global Phase 3 programme for its glucagon-like peptide-1 agonist, lixisenatide, for type 2 diabetes.
In seeking to increase R&D productivity, Big Pharma should consider outsourcing all of its discovery activity and focus instead on building capacity in translational medicine, Simon Moroney, the MorphoSys chief executive, told a meeting in London.
The UK National Institute for Health and Clinical Excellence is considering expanding its programme of scientific advice to include medical device companies and possibly venture capitalists, Andrew Dillon, the chief executive, told a meeting in London.
Venture-capital backed ArGEN-X BV of the Netherlands said that it has advanced a third therapeutic antibody candidate into preclinical development, in this instance an antibody targeting the c-Met signalling pathway which is implicated in many cancers.
Sanofi SA reported mixed results for 2011 with a modest rise in sales, a decline in operating income and a rise in net profit resulting from a lower tax liability.
H. Lundbeck A/S reported an 8% increase in revenue for 2011. But restructuring and other costs increased at a faster pace leaving a profit from operations up by a smaller 1%. A higher tax bill meant that net income fell by 7% to DKK 2,282 million.
Anacor Pharmaceuticals Inc said that enrolment of patients into four studies of a new agent against Gram-negative bacteria, GSK052, has been stopped pending investigation of a microbiologial finding in a small number of patients.