An FDA decision to revoke designation of a drug (or a biological product) as an orphan drug is a rare event. (Though it’s not as rare as revocation of orphan drug exclusivity, which has happened only once – see our previous post here). Until recently, we were aware of only three orphan drug designation revocations in the 30-plus year history of the Orphan Drug Act. That number more than doubled in April 2016 when FDA revoked four orphan drug designations for various drugs for the treatment of hypertension in pediatric patients.
FDA’s orphan drug regulations (21 C.F.R. § 316.29(a)) provide three independent bases under which orphan drug designation can be revoked – if FDA finds that:
(1) The request for designation contained an untrue statement of material fact; or
(2) The request for designation omitted material information required by [21 C.F.R. Part 316]; or
(3) FDA subsequently finds that the drug in fact had not been eligible for orphan drug designation at the time of submission of the request therefor.
The four new revocations share several similarities. There are the obvious similarities of indication and timeframe of designation. But also note that in each instance FDA’s Orphan Drug Designations and Approvals database identifies the dosage form of the designated drug. That’s unusual and likely indicates that orphan drug designation was granted based on a plausible hypothesis of clinical superiority (perhaps “greater safety” or “major contribution to patient care”) because FDA had previously approved the same drug (i.e., active moiety) for the same rare disease.
As to FDA’s basis for revoking orphan drug designation for the four drugs above, we suspect that FDA stumbled upon some information that the Agency believed supported withdrawal and then determined that each drug “had not been eligible for orphan drug designation at the time of submission of the request” because the United States prevalence of pediatric hypertension exceeded the 200,000 person cut-off.
Public service advertising doesn't often go viral (indeed, PSAs rarely appear on Google and Adweek's monthly leaderboard of the most-watched ads on YouTube). But the Ad Council knocked it out of the park last month—notching almost 50 million views (it has since topped that) for the R/GA-produced "Love Has No Labels" spot.
Samsung, which often dominates the leaderboard, placed another two spots in March, battling Durex's "#Connect" ad for the No. 2 slot.
Elsewhere, Geico's unskippable pre-roll ads proved to be just that, as the family-dinner ad got more than 5 million views. And YouTube itself placed two spots on the March list, for one of its #DearMe spots and for YouTube Music Awards welcome video.
The marketing industry has a crisis on its hands. Most marketers don't know how to successfully craft and execute a digital strategy or measure ROI, according to a recent study. This is the marketing skills gap, and ninety percent of marketers say their team suffers from it. So what can they do?
The problem isn't that the marketer's role has fundamentally changed in the digital era. Rather, the technology they're expected to use is continuously transforming. Meticulous data management, stellar content and an optimized cross-channel approach have become expected. Unfortunately, many managers at agencies have a hard time keeping up.
"The Future-Proof Marketer in 2015," a new guide from Grovo, explains how organizations can educate a new kind of marketer—one with a keen sense of how customers interact with brands, content and products. These are the skills the guide covers in detail....
The controversy over the pricing of Gilead’s Sovaldi for Hepatitis C is a textbook example of price discrimination in action. I hope that my quick review of some of the principles involved will help explain what’s going on.
Although the anti-Gilead people have a valid perspective, my sympathy is mainly with Gilead. The concept of price discrimination: charging different prices to different customers based on willingness or ability to pay, maximizes a monopolist’s profits but it also maximizes societal benefit. As the simplified chart below illustrates, Gilead makes the most money if it can sell the medication at different prices in different countries. That also leads it to sell the highest quantity of product, meaning more people can be treated.
Crafting excellent social media posts and calendars is vital if you want your social stay to be a powerful and successful one. However, you might be hitting the proverbial brick wall with your posts, and might not be sure just how to go about crafting great posts all the time. Fret no more; I have gathered several great templates that can help you begin planning excellent social posts and content!
Throughout this post, I will be focusing on a great resource from Content Marketing Institute with a great list of awesome templates. Take a look and see which will be perfect for you and your brand....
How effective is social media in comparison to other digital marketing channels? Do consumers actually listen to brands? Do brands actually listen to consumers? How does B2B social media marketing differ in effectiveness from B2C use? Which netork drives half of all social traffic to B2B websites and blogs?
What type of posts generate the most engagement on Facebook? What do 91% of consumers check daily? What do more than half of marketers identify as their most critical areas of focus over the next 12 months?
Find the answers to those questions and many more here in 106 digital marketing facts (well, mostly) and statistics from two dozen sources....
Findings based on a survey of 1,150 patient groups (from 58 countries and of differing specialties)Survey conducted mid-November 2014 to mid-January 2015Patient-group feedback on the corporate reputation of the entire pharma industry during 2014Patient-group feedback on the corporate reputation of 37 individual pharma companies in 2014Results for 2014 are compared with those of 2013, 2012, and 2011
The 37 pharma companies reviewed in the study are: AbbVie l Actavis l Allergan l Amgen l Astellas l AstraZeneca l Baxter International l Bayer l Biogen Idec l Boehringer-Ingelheim l Bristol-Myers Squibb l Celgene l Eisai l Eli Lilly (Lilly) l Gilead l GlaxoSmithKline (GSK) l Grũnenthal l Ipsen l Janssen l Lundbeck l Menarini l Merck & Co (USA) l Merck KgA (Germany) l Mylan l Novartis l Novo Nordisk l Otsuka l Pfizer l Roche l Sanofi l Servier l Shire l Stada Arzneimittel l Takeda l Teva l UCB l ViiV Healthcare
The corporate reputation of individual pharma companies (as seen from a patient perspective) shows some significant changes between 2014 and 2013 (37 companies assessed in 2014; 33 companies in 2013).
Evidence for strong employee engagement levels has never been clearer, with recent research conducted by Business in the Community (BITC) and Ipsos Mori indicating a critical link between strong human capital management and organisational performance.
FTSE 100 companies that have robust arrangements for reporting on employee wellness and engagement have been found to outperform the rest by 10%. We also know that investors are demanding a clearer and more consistent way to understand how organisations are managing their most important asset – people. But there is a lack of transparency in public reporting about employee engagement and wellbeing.
In April, BITC published the Workwell FTSE 100 benchmarking results, which track companies' public reporting in five key areas: better physical and psychological health, better work, better specialist support, better relationships and working well.
The other thing I have to emphasize is that in order for a lot of these ideas to work for you, you need to think of content as something way beyond simply a marketing tactic – you need to embrace it in everything you do on your site and offsite – take for example Ian Lurie’s (from Portent – an organisation whose thoughts on content clearly mirror mine ) post on Content as part of UX over at Moz. And like I point out in the Content is King post, and as Ammon Johns points out in this piece “The Great Content marketing Swindle“, content without a real distribution channel is simply content, not content marketing.
Every single one of these ideas below need a distribution and display strategy for them to work.By no means is this list exhaustive, but it can form a good start to any content plan. Some of the areas may not apply to all businesses, while others will – I have taken the approach of top down- starting with the core corporate communication and then working my way into the more creative areas....
I prepared the chart on the left for the Pharma Marketing News article "DTC Ad Spending Rises from the Grave," which was published this Monday. You should compare this version of the chart to the one I published here on Pharma Marketing Blog last week (here).
This chart says 5% of pharma's 2014 DTC ad budget went to the Internet (excluding search), whereas the previous version says only 3%.
This chart says 63% of the budget went to TV, whereas the previous version says 70%.
I'll ignore print for now.
Determining the exact amount that the pharmaceutical industry spends on advertising via different media (TV, print, Internet, etc.) is a daunting task. Numbers regarding pharma DTC spending come from two sources: Nielsen and Kantar Media. Both report "measured media" spending, which includes TV, magazines, news-papers, radio, outdoor, and Internet (display ads only, not including search). Kantar tracks over 3,000 media sources throughout the US and Canada, which is a different methodology than that used by Nielsen. As a result, the numbers from these sources often do not match (for more on that, read "Making Sense of Pharma DTC Spending Trends").
The Intellectual Property and Science business of Thomson Reuters, the world’s leader in intelligent information for businesses and professionals, today released the 2015 edition of its annual Drugs to Watch report. The study reveals a significant increase in the number of expected blockbusters from three drugs in 2014 to eleven in 2015. Three of the new drugs are expected to reach over $3 billion in sales by 2019.
In this post we won’t give you any graphic design elements for creating infographics, but instead we will showcase 20 best social media infographics with useful info you will definitely want to check out! These great social media infographics will teach you lots of useful things, from how to spot trolls and how to deal with them, to secret formulas for viral shares on social media!...
Are you running a startup? Read this post about how Groove HQ has grown their startup through content marketing if you need to be convinced.
Below is an epic list of content marketing resources. We reference this list often at our agency. We hope you can use it for your startup or company. It’s a selection of content marketing articles, tips, resources, examples, case studies, tools, inspiration, and more...
From thinking of what to write, doing the research, to constructing the first few sentences of our work – it will never be the same process because it’s always a unique struggle every time. Fortunately in this age, we are blessed with apps, online tools, and websites that can lessen the struggle of writers.
If you’re a blogger, content writer, journalist, or novel writer, here are 10 FREE online tools that I recommend you to use to make your writing life a whole lot easier:...
When it comes to social media, lately I’ve been surprising myself by how often I’m turning to LinkedIn. With the addition of LinkedIn Publishing, there seems to be more awesome content on the business social network than ever before.
And I don’t think I’m alone. LinkedIn has more than 347 million users across more than 200 countries and territories worldwide.
Did you know that 80 percent of LinkedIn users say they want to connect with companies? Which is great news, because users are almost 50 percent more likely to buy from a company they engage with on LinkedIn.
I thought I would share all the stats I’ve found with you here in the hopes that we can fine-tune our LinkedIn marketing and improve our LinkedIn Company pages together....
Did you know that more than 4 out of 5 consumers value word of mouth recommendations over all other sources? Amazing isn’t it? The power of a trusted opinion!Local influencers are people Small Businesses should target.
This recent blog talks about the importance of connecting with local influencers to increase your word of mouth. There are 2 data points are worth considering:
- Consumer-to-consumer word of mouth generates more than double the sales of paid advertising (Source: McKinsey)
- 84% of consumers say they trust word of mouth recommendations from friends and family above all other sources of advertising. (Source: Nielsen)...
For the second year in a row, ViiV Healthcare, a joint venture between Pfizer, GlaxoSmithKline, and Shionogi and headquartered in the U.K. (which may also have the biggest IPO for a pharma company ever later this year), emerged as number one.
According to PatientView, the six indicators of corporate reputation include patient centricity, patient information, patient safety, useful products, transparency, and integrity. ViiV took the top spot for its outstanding performance in three key areas: patient centricity, providing high-quality patient information, and patient safety, and providing useful products.
Manuel Goncalves, Head of Government Affairs, Patient Advocacy, Community Partnerships, Access, and Communications at Viiv Healthcare, told BioPharma Dive, “We are delighted that for the second year running, we have been ranked first in the PatientView survey ‘The Corporate Reputation of Pharma in 2014 – the Patient Perspective’. Everyone at ViiV Healthcare is committed to put patients’ interests at the forefront of what we do every day.”
Focusing on patients
A key takeaway from the survey's results is that patient centricity has become as a top indicator of a biopharma company’s reputation. But what exactly ispatient centricity?
Sharing your scoops to your social media accounts is a must to distribute your curated content. Not only will it drive traffic and leads through your content, but it will help show your expertise with your followers.
How to integrate my topics' content to my website?
Integrating your curated content to your website or blog will allow you to increase your website visitors’ engagement, boost SEO and acquire new visitors. By redirecting your social media traffic to your website, Scoop.it will also help you generate more qualified traffic and leads from your curation work.
Distributing your curated content through a newsletter is a great way to nurture and engage your email subscribers will developing your traffic and visibility.
Creating engaging newsletters with your curated content is really easy.