Ben Comer

As the UK exits the European Union, the pharmaceutical and life sciences industries should prepare for changes by identifying key business issues, mitigating risks and creating plans for multiple scenarios.

 Specialty drug sales, record-breaking M&A paired with tax synergies, and global expansion helped to bring a new face into this year’s Pharma 50 top 10, and substantially boosted the rankings of several others.    

Successfully commercializing a proprietary drug in China can be a Kafkaesque affair.

FDA officials willing to relocate to far-flung global cities should be congratulated for their herculean efforts to protect American patients. But funding cuts hamper the Agency's international presence.

“It doesn’t turn me on to send a warning letter.” –Tom Abrams, during a Q&A at DIA.

Non-adherence, in the US alone, is a $100-billion-a-year problem. Healthcare players are touting patient education and engagement as the keys to better adherence rates. Ben Comer reports.

The Cancer Research Institute is clearing a path to the future of immunotherapeutics. Ben Comer speaks to its CEO and director of scientific affairs, Jill O'Donnell-Tormey

Pharm Exec’s Brand of the Year selections from the last few years are still alive and kicking, although some have aged more gracefully than others.

We check back with previous Pharm Exec Brand of the Year winners to see how things are going.

Pharm Exec's Brand of the Year recipients for 2014 are multiple sclerosis treatment Copaxone and KORLYM for diseases driven by excess production of the metabolic hormone, cortisol. We profile the journey of both drugs.

Ben Comer reports on how new pipeline therapies, public research investments, and a renewed sociopolitical focus are working toward a happier outcome for sickle cell disease patients.

If the American public could shed girth as quickly as many medical journals have in recent years, we’d all be a lot healthier.

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch.

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch.

Cash-strapped states are shifting patients from traditional fee-for-service Medicaid coverage to managed Medicaid plans.

Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree.

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not.

When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.

New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect.

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.

Advocacy organizations and individual patients are getting more involved in every facet of the healthcare system, from drug R&D, to federal and state policy all fueled by the hour-to-hour passion of living with a disease.

For Big Pharma, the merits of strategic focus and operational discipline are more important than ever. It is time to be decisive - muddling through is so yesterday.

The IMS Institute for Healthcare Informatics worked up a methodology for assessing the effectiveness of pharma’s social media efforts across Facebook, Twitter and YouTube.

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action.

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014.

Happy New Year! We at PharmExec are looking forward to a busy and hopefully fortuitous 2014. For our colleagues in the Northeast bracing for yet another snow storm – and for those of you with better short-term environmental prospects – here are the 10 most-read stories published on PharmExec‘s blog during 2013, in case you missed them:

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.

Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, GSK’s blockbuster fluticasone propionate/salmeterol xinafoate combo inhaler.

Why do some doctors prescribe more generic drugs than others?

Can big pharma solve its fixed cost problem by going virtual? Not entirely, but drug companies can get more out of their CRO partners by treating them less like avatars and more like equals, according to conference-goers at a CBI event in The Triangle.