Dose of Digital
- What “Big Pharma” Can Learn from “Little Startups” What “Big Pharma” Can Learn from “Little Startups”
First things first, hello. If you’re a new reader to the blog, you probably don’t remember me, but if you’re a veteran, you just might. It’s me, Jonathan Richman, the original founder and author of Dose of Digital ba [...]
- “Journalism” “Journalism”
My favorite line from the piece, got added AFTER it ran for days. “Correction: This video was actually created by marketing students at Berghs School of Communication, and is not made by Google, nor is Google Gesture a real service. W [...]
- 5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations 5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations
The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media. The first was entitled, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about pre [...]
- 5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation 5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation
Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformat [...]
- Who Responds To The Responders? Who Responds To The Responders?
As I thought it might, my last post about social media stirred quite a bit of discussion. As such, I thought it would be useful to perhaps dedicate another post as a means of both clarifying my position, and providing some counter-points t [...]
- 2014: The Year for FDA Guidance on Social Media 2014: The Year for FDA Guidance on Social Media
Many in the pharma industry have been anxiously awaiting social media guidance from FDA. Going all the way back to November 2009, FDA has repeatedly promised to provide more clarity around how it intends to regulate pharmaceutical promotion [...]
- FDA Draft Guidance Opens Up Social Options for Pharma FDA Draft Guidance Opens Up Social Options for Pharma
Whew! On Monday FDA quietly issued draft guidance titled, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” In language that you an [...]
- Let's Give Our Friends at Med Ad News a Proper Send-off Let's Give Our Friends at Med Ad News a Proper Send-off
I was shocked and sad to learn that industry publication Med Ad News will no longer exist. The publisher recently sent this email to customers:December 13, 2013RE: Closure of MedAdNews/Pharmalive/Pharmalot/eKnowledgeBase/R&DDear Valued [...]
- What Every Pharma Procurement Group Needs: A "Rogue Agency" Roster What Every Pharma Procurement Group Needs: A "Rogue Agency" Roster
I read with interest the report in the June issue of MM&M, "Healthcare Marketers Trend Report 2013." The report benchmarks and analyzes topics that affect pharma marketers such as budgets, channel mix, perceived challenges, and more. On [...]
- Pharma's First Branded Facebook Ad? Pharma's First Branded Facebook Ad?
I was goofing around on Facebook last night when I noticed what looked suspiciously like a branded pharmaceutical advertisement:It was indeed an ad for Axert, a Janssen migraine treatment, and one click took me to the home page for Axert.c [...]
Eye on FDA
- Cloudy Forecast on Sunshine Act Data Release? Cloudy Forecast on Sunshine Act Data Release?
In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of … Contin [...]
- Weekly Roundup 8.15.14 Weekly Roundup 8.15.14
It is hard to believe that I see on Facebook many of my friends who are parents talking about their kids headed back to school this week. Back to school? Back to school? Why when I was a lad, which … Continue reading →
- Weekly Roundup 8.7.14 Weekly Roundup 8.7.14
August is supposed to be slow. And lazy. Laying around doing nothing. That is what Marky the Cow is doing in this picture. (For those of you who are new to Eye on FDA, Marky is a dairy cow in … Continue reading →
- To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter
On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza. The agency announced the approval by sending out a press release. The agency also sent out this tweet: [...]
- Upcoming AdComms By Subject Matter Upcoming AdComms By Subject Matter
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often. Today is every so … Continue reading →
Pharma Marketing Blog
- FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe
In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for a [...]
- FDA Targets Companies for Facebook 'Likes.' Is Twitter 'Favorites' Next? FDA Targets Companies for Facebook 'Likes.' Is Twitter 'Favorites' Next?
FDA Targets Companies for Facebook 'Likes.' Is Twitter 'Favorites' Next?
- Why I Will Be Attending Digital Pharma East Why I Will Be Attending Digital Pharma East
Rich Meyer initiated quite a controversy on his World of DTC Marketing blog when he posted a "guest" article by an anonymous "Senior Director for a top pharmaceutical company" who explained why he won't be attending [...]
- #mHealthEthics: A Call for Pharma to Develop Mobile Health "Guiding Principles" #mHealthEthics: A Call for Pharma to Develop Mobile Health "Guiding Principles"
According to a "Client Alert" from Pillsbury Winthrop Shaw Pittman LLP, FDA’s new draft guidance that would exempt from premarket 510(k) review many low-risk medical devices may "smooth the path to market for many medical mob [...]
- What Types of Health Info Do Mobile Users Seek and Is It Relevant to Advertisers? What Types of Health Info Do Mobile Users Seek and Is It Relevant to Advertisers?
You don't hear much about it, but pharma advertises on mobile devices. An Astellas marketing campaign for its overactive blade drug, Myrbetriq, for example, included an interstitial ad in a mobile app that drove viewers to a mobile-opti [...]
- A new blog to follow: Chaos Theory and Human Pharmacology A new blog to follow: Chaos Theory and Human Pharmacology
- Pharmalot is THE BEST Pharmalot is THE BEST
- Illinois Suspends Michael Reinstein's Medical License Illinois Suspends Michael Reinstein's Medical License
- Why might Alltrials be mired at the EMA one wonders? Why might Alltrials be mired at the EMA one wonders?
- Broken Broken
- Compounder Strikes Preliminary $100M Deal Over Meningitis Outbreak Compounder Strikes Preliminary $100M Deal Over Meningitis Outbreak
More than a year after an outbreak of fungal meningitis was traced to the New England Compounding Center and caused the worst public health crisis in the US in decades, the owners, operators and insurers of the bankrupt com [...]
- What Competition? Actelion Loses Case Over Stifling A Rival Drug What Competition? Actelion Loses Case Over Stifling A Rival Drug
For the second time this year, Actelion has been tagged for questionable behavior toward rivals. In the latest instance, a California state court judge has upheld a $407 million jury award that was made after the drugmaker [...]
- The Affordable Care Act Gives Drugmakers A Boost: CMS The Affordable Care Act Gives Drugmakers A Boost: CMS
What hath the Affordable Care Act wrought? For drugmakers, there looks to be a big boost in spending on prescription medicines. Projected spending is forecast to grow 5.2 percent next year, compared with 0.6 percent growth [...]
- Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All? Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All?
In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill. The move was expect [...]
- Pharmalot... Pharmalittle... Good Morning Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We hope the weekend was relaxing and invigorating, especially for those of you who are resuming something resembling the usual routine this morning. Of course, we recognize thi [...]
The IN VIVO Blog
- Deals of the Week Takes Stock in M&A Deals of the Week Takes Stock in M&A
Here at Deals of the Week, we don’t often take note explicitly of buyouts outside the biopharma sphere. But one well-publicized tech deal last month piqued our interest – and it parallels another recent pharma deal in a way we found curious [...]
- What Is the Buoyant Biotech IPO Scene Doing to Private Biotech M&A Trends? FOTF Says: Not Much What Is the Buoyant Biotech IPO Scene Doing to Private Biotech M&A Trends? FOTF Says: Not Much
Despite a slight slowdown, there's considerable cash already sloshing around the biotech IPO space. There's (still!) plenty more stacked up in investor suitcases from California to the New York Island just waiting to back anything with a pu [...]
- Stakeholders in Consumer Genomics, Read This Stakeholders in Consumer Genomics, Read This
Noting a flurry of recent commentaries in peer-review journals, our February Science Matters column in START-UP (link here, free access) discussed how the personal genomics company 23andMe has accelerated the consumer genomics debate throug [...]
- DOTW Keeps Tabs As Tax Trimming Fuels Deals DOTW Keeps Tabs As Tax Trimming Fuels Deals
As an industry, biopharma actually fares pretty well when it comes to taxes. Among profitable companies, biotech and pharma have some of the lowest effective U.S. tax rates compared to companies in other sectors. But that doesn’t mean they [...]
- Deals Of The Week: Novartis Places Bid To Dominate In Cancer Deals Of The Week: Novartis Places Bid To Dominate In Cancer
While the largest deal of the week, and certainly the one receiving the most attention, has been Actavis' expansion of its branded portfolio via its $25 billion purchase of Forest Laboratories, the deal that could have major implications fo [...]