Ben Comer

Articles by Ben Comer

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FDA Abroad

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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.

Promoting Adherence: From Force to Finesse

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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.

2014 Brand of the Year

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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.

Sickle Cell Disease In Three Acts

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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.

New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

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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.

Compliance Congress: Walking the Line

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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.

The Active Patient: Faces Of Change

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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.

IMS's Top 10 Pharma Social Media Engagers

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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.

J.P. Morgan: Pharma's Agenda for 2014

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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.

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Ibrutinib's Breakthrough to Market

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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.

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PharmExec's Orphan Drug Pipeline Picks

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Orphan drugs were given short shrift in PharmExec’s 2014 Pipeline Report, but a couple of pipeline candidates targeting small populations did make the list, and are expected to earn big dollars in the next few years.

Top Medical Innovations for 2014

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At the conclusion of the Cleveland Clinic's Medical Innovations Summit each year, 10 innovative technologies are unveiled before the audience, and designated as new and revolutionary tools for the treatment of disease and disability.

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How to Win in the Diabetes Space

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Novo Nordisk’s SVP of national diabetes sales speaks with PharmExec about a new field force technology initiative, implications of the Sunshine Act, and why Victoza sales won’t slow down anytime soon.

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Take a Chill Pill

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In the spirit of lawn chair cogitation and hammock-spun reverie, Pharm Exec invites you to submit your own verses-pharma-related, of course-to be published on our website in late August.

Lanham Act Peer Review on Trial

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Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage?

Takeaways from the Post-Approval Summit

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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.

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Regeneron: New York State of Mind

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Led by two New Yorkers with a mindset that marries novel scientific insights to the processing power of novel technologies, Regeneron's success is a revolutionary challenge to the industry status quo.

From Locked Box to Data Sphere

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Project Data Sphere aims to liberate clinical trial data sets from industry and academic vaults, in an attempt to catalyze cancer research and discovery.

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