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Tensions 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.

On June 17, 2013 the Supreme Court decided FTC v. Actavis by a 5-3 vote. Justice Breyer delivered the majority opinion with Justices Kennedy, Ginsburg, Sotomayor and Kagan concurring.

Last week, the US Supreme Court issued a long-awaited decision in Myriad Genetics, which sent shockwaves through the very foundation of the biotech industry

Along 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.

NHS 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.

A 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’

The 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.

Speakers at the 2nd annual Financial Times US Healthcare and Life Sciences conference in New York last week discussed the cost of health, and the implications of an increasingly vocal and influential stakeholder group: the local populace.

In its 16th year, the Pharma 50 provides a unique window on the pace of industry change, with a focus on global, not just US revenues, and on revenues specifically from pharmaceuticals: patented, branded and generics. This approach gives a fuller, more rounded insight that tracks where the industry is heading ? and how well the science that drives progress in medicine is performing.

Value-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.

Dr. Richard Gliklich, president of Quintiles Outcome and a professor at Harvard Medical School, highlights the most prominent post-approval issues and risks coming out of this year’s Post-Approval Summit, held on May 7th-8th.

One of the most promising pharmaceutical markets of the future is Brazil, a nation of nearly 200 million people with a universal healthcare system.

Within the billions of daily comments from individuals across open social sources lies deep intelligence into markets, brands, patients, caregivers, healthcare providers and competitors.

The latest stage of Europe’s attempt to update its clinical trials rules offered a mildly distressing spectacle of the intrusion of politics into policy, writes Peter O’ Donnell.

Getting patients to take their medicine on spec and on time is the challenge that never goes away-it's the deadweight baggage accompanying every industry innovation since the arrival of aspirin a century ago.

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PharmExec sat down with Colleen A. McHorney, PhD, former Senior Scientist at Merck’s U.S. Outcomes Research to review her long record of scientific research on adherence in advance of her retirement last month.

Pharmaceutical Executive offers a unique platform to engage with high level executives at pharmaceutical companies across multiple platforms

New 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).

I’m sure you’ve heard already - Internet geriatric Yahoo just bought six-year old Tumblr for $1.1 billion. The deal, likely to complete in the second half of this year, is almost all cash - reportedly almost all the cash Yahoo had in hand at the close of the first quarter.

For CEOs who have spent long years and countless funds building a solid pharmaceutical brand and life-changing drugs, discovering defamatory remarks about your company online can come as quite a shock.

If you are an Rx regional sales director or a product marketing manager, I have a somewhat provocative question for you: How exactly are you planning your 2014 Medicaid strategy?

The 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.

US-based Bayer Healthcare Pharmaceuticals, as its executives were quick to point out, has now received three new approvals for cancer indications in the last eight months

The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain

The problem we see with the polarity of views is that both sides seem to be cranking up the extrapolation machine and use single studies/data points to draw broad conclusions to gin up opinions about ACA’s success or lack thereof.

At a time when Big Pharma is struggling with new business models geared to the demands of a changing marketplace, the Medicines Patent Pool (MPP) is offering a way forward through voluntary licensing and patent deals that it insists will deliver what the drug majors say they want: more innovation; better market access; and the opportunity to demonstrate measurable improvements in public health. Is the MPP, as founding chair Phillipe Douste-Blazy claims, that “new business model for the future?”

It’s exciting times for patents in Europe. Not everyone’s excitement is pleasurable, but there’s certainly plenty going on, writes Reflector, Pharm Exec‘s EU correspondent.