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GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets, according to a Feb. 22, 2012, FDA enforcement report

In 1983-with the help of Abbey Meyers and the drive she had to help her son (more on that here)-the Orphan Drug Act was passed to incentivize pharma to step up and play an active role in drug development for the 30 million children and adults in the U.S.

With an all-important FDA decision on carfilzomib scheduled for July 27, Onyx hopes to graduate to the next stage of commercial success. For a feature-length profile of Onyx and CEO Tony Coles

Publicis Healthcare continues its expansion into Asia with this week’s announcement of its acquisition of U-Link Business Solutions (UBS), one of China’s leading agencies specializing in healthcare communications.

So far, the creative approaches industry has taken to develop tamper-resistant and abuse-deterrent opioid drugs have been largely matched by the ingenuity of those users who manage to tamper with and abuse those same formulations.

Whichever way you look at it, 2012 will be a dramatic year for Servier. The French company has a number of collaborations that could lead to a new generation of products, but any positive news from these developments is likely to be overshadowed by the ongoing safety scandal of its diabetes treatment Mediator (benfluorex hydrochloride).

A new collaboration will move FDA closer to predicting adverse events – before they happen – as part of the regulatory process

As health reforms sweep in major changes to our nation’s healthcare system, patient assistance and access programs (PAPs) are rapidly evolving to assess and meet new needs.

As the hurdles to successful commercialization of new medicines continue to mount, the ability to find and exploit cost efficiencies in the development process has become a critical source of competitive advantage.

As the perceived urgency for transparency and compliance in global pharma grows ever stronger, the ‘Sunshine provisions’ of the US’s Patient Protection and Affordable Care Act (ACA) seem increasingly aptly named

All-told the Mayo Clinic’s recent pilot study on clinical trial patient recruitment using social media and online networks not only helped researchers assemble large and demographically diverse patient groups more quickly, but also less expensively than they could through other means

William Looney’s posting for this blog, “Calculating the Cost of R&D: Defending Tufts Research” (January 11, 2012), raises a number of interesting and important points.

A report released on Feb. 8, 2012 from the California Healthcare Institute, BayBio and PwC shows that the shrinking economy, changes in investment strategies, and pressures on the pharmaceutical market have put the brakes on one of the US’s most robust biotechnology centers

Following the premise that good news needs to be shared, Pharm Exec is proud to announce that one of our sister Advanstar publications, Medical Economics, has been selected as Media Brand of the Year by Medical Marketing and Media (MM&M) magazine.

Of the 399 senior executives in the life sciences industry surveyed by the Economist Intelligence Unit (EIU) recently, 64% of respondents said that demonstrating value is a key challenge facing their business. The major issue, most agree, is that stakeholders have different perceptions of what value is.

David Torstensson, Senior Consultant, Pugatch Consilium, considers what the London Declaration on Neglected Tropical Diseases reveals about research and development efforts into neglected and tropical diseases.

HCLBlog

At the digital marketing-focused ePharma Summit in New York this week, many of the problems and frustrations related to the “big three” – Facebook, Twitter and YouTube – were hashed out for umpteenth time.

The Healthcare Businesswomen’s Association (HBA) has announced that its 2012 Woman of the Year (WOTY) is Carolyn Buck Luce, global pharmaceutical sector leader at Ernst & Young.

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.

In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research“

Brand of the Year : Abbott's Humira

William Looney looks at the three P’s of effectiveness research: PCORI, Priorities, and Politics

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry.

New pharma supply chains, where chill control and traceability challenges will be far more critical, will emerge over the next decade, So it’s time, argues Julian Mosquera, for the industry to upgrade its capabilities.

Even though Roche-owned Genentech wasn’t required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway.

The 2011 Edelman Health Barometer suggests that-in the same way that we spread colds, diseases, and other illnesses from person to person-good health and healthy behaviors can also be spread. Can pharma play a pivotal role in the good-health epidemic?

One of the few positive notes struck in this week’s 30th Annual J.P. Morgan Healthcare Conference (held in San Francisco) was the announcement by Kevin Willsey, J.P. Morgan’s co-head of investment banking for North America, that the U.S. economy would grow 2.5 percent in 2012

Estimates of what it takes to deliver a compound to market are more than an academic exercise - such data has an increasingly important on-the-ground impact on industry revenues, because if you cannot justify your costs how do you expect to prevail on price?