EU Tense as CrunchTime for Counterfeits Approaches
June 24th 2013Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out of the legal supply chain. The manufacturing industry will have to carry the cost of much of the chosen system - and there is wide disagreement about what sort of system should be introduced, and who should pay for it.
Video: Flemming Ornskov on Shire Strategy
June 18th 2013Along with the details of an ambitious new organization restructuring and strategic product plan, Shire CEO Flemming Ornskov emphasizes talks about the importance of alignment with the customer and the untapped potential from Shire’s expertise in that sweet spot in specialty – rare diseases.
Helping Patients Lead the Way in the New NHS
June 18th 2013NHS England is currently undergoing profound changes to introduce a new culture where clinicians and patients are the new stars, where competition is mandatory, where everything rests on patient outcomes and where collaboration and innovation are being encouraged at the highest levels of command.
2013: The Year of Mobile Health
June 18th 2013Mobile health is getting some serious attention this month - from an unusual but inspiring new Apple ad to some grandiose forecasts for mHealth’s potential impact on European budgets, the first reimbursable mobile app to an ambitious new study setting out to spotlight the best examples of mHealth by the leading Pharma companies.
England's Latest Innovation Scorecard: A Patchy Picture
June 14th 2013A common gripe from those in the pharma industry in England is that even when their products have been found to be cost effective by the National Institute for Health and Care Excellence (NICE) (not always easy to do these days), uptake in the NHS can be ‘low and slow’
Myriad Decision: Praise and Perils for Biotechnology Patent Policy
June 14th 2013The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics. Although some commentators regarded the decision, Association for Molecular Pathology v. Myriad Genetics, as a “major reversal” in longstanding patent policy, many leaders of the biopharmaceutical research community described the ruling as likely to spur innovation and the development of therapies and companion diagnostics necessary for advances in personalized medicine.
FDA Issues Warning Letter to Novartis's Austrian Plant
June 10th 2013FDA has issued a Warning Letter to Novartis for cGMP violations at its manufacturing facility for finished pharmaceuticals in Unterach, Austria. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009.
UK Value-Based Pricing: Will Scotland Take a Different Approach?
June 10th 2013Value-based pricing (VBP) continues to confuse many in the UK and further afield. The Scottish Parliament’s Health and Sport Committee is the latest parliamentary committee to question civil servants about what it’s all about.
Woodcock Urges Forward March Toward Personalized Medicine
May 29th 2013New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
The UK's New "Revolutionary" Medicines Optimization Plan
May 21st 2013The UK’s Royal Pharmaceutical Society has joined forces with a number of other organizations, including the Association of the British Pharmaceutical Industry (ABPI), to issue new guidance on medicines optimization. Sir Bruce Keogh, Medical Director of NHS England, says it could be revolutionary.