Category Archives: Op-Ed

Will the Supreme Court Spur OTC Contraceptive Development?

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth […]
Also posted in FDA, healthcare, Regulatory | Tagged , , | 1 Comment

FDA’s Patient Outreach: Finding Ties that Bind

Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
Also posted in Events, FDA, Meetings, Regulatory, Safety | Tagged , , , | Leave a comment

Making the Most of Social Media (Within FDA’s New Guidelines)

By Ken Ribotsky. Pharmaceutical companies have begun using social media for business needs and promotion, yet have been hesitant to become too engaged since the FDA’s stance on social media activity remained unclear. But now that we know the FDA’s specific guidelines for pharma companies’ actions online, it’s time for brands to consider diving into […]
Also posted in compliance, E-Media, FDA, Guest Blog, Regulatory, social media | Tagged , | 1 Comment

The Rx Firm Tax Exodus: Is Something Wrong with the U.S. System?

As I read the latest reports of yet another big US Rx firm, this time AbbVie, trying to pull off a “tax inversion” takeover of the Irish-based Shire, I couldn’t help but wonder, what the heck is going on here? Right now, it feels like most major US corporations, especially pharmas, are literally running away […]
Also posted in Deals, Europe, Global, Guest Blog, Legal, Strategy | Tagged , , , , , , | Leave a comment

The Urge to Merge: Dealmaking Lessons from Pharma History

By Cliff Kalb. The major pressures hindering pharmaceutical industry success have not changed—payer constraints on drug costs, R&D productivity, an increasingly risk-averse regulatory climate, generic encroachment, and negative public perceptions linked to reputation. Looking at the latest rendition of the Pharma 50, prescription drug revenue rankings for the top 10 major global players in 2013 […]
Also posted in Deals, Global, Strategy | Tagged , , , | Leave a comment
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