La pharma dans tous ses états
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La pharma dans tous ses états
Partage autour de l'univers Pharma, ce qui bouge, ce qui reste, et ce qui devrait bouger.... Actualités, temps forts, tendance,...
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#Journée de la #scléroseenplaques #SEP : "Aujourd'hui on compte trois femmes atteintes pour un homme" #hcsmeufr 

#Journée de la #scléroseenplaques #SEP : "Aujourd'hui on compte trois femmes atteintes pour un homme" #hcsmeufr  | La pharma dans tous ses états | Scoop.it
À l’heure actuelle en France, 100 000 patients vivent avec la sclérose en plaques. Parmi eux, une majorité de femmes, jeunes, de race blanche, et vivant dans les pays urbanisés. Comment expliquer qu’elles soient les premières touchées ? A l’occasion de la Journée mondiale de la sclérose en plaques, nous avons interrogé Jérôme de Sèze, neurologue au CHRU de Strasbourg.

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GIE_GERS's curator insight, May 30, 1:03 PM

À l’heure actuelle en France, 100 000 patients vivent avec la sclérose en plaques. Parmi eux, une majorité de femmes, jeunes, de race blanche, et vivant dans les pays urbanisés. Comment expliquer qu’elles soient les premières touchées ? A l’occasion de la Journée mondiale de la sclérose en plaques, nous avons interrogé Jérôme de Sèze, neurologue au CHRU de Strasbourg.

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Drug pipeline: 1Q18

Drug pipeline: 1Q18 | La pharma dans tous ses états | Scoop.it

Box 1: Historic US regulatory approvals by drug class

 

Approvals were down last quarter. Vertex (Cambridge, MA, USA) got a green light for its small-molecule combination to combat cystic fibrosis; Theratechnologies (Montreal, Quebec, Canada) and Sun Pharmaceuticals (Mumbai, India) received registrations for monoclonal antibodies (mAbs) to treat HIV and psoriasis, respectively. A gene therapy suffered a clinical setback in Duchenne muscular dystrophy. Decisions await several new therapeutic modalities, including short-interfering RNA (siRNA) and ASO therapies against transthyretin-related (TTR)-hereditary amyloidosis; an antibody–drug conjugate for hairy cell leukemia, a nanobody against thrombotic thrombocytopenic purpura and the first new anti-malarial in 60 years.


Via Krishan Maggon , Lionel Reichardt / le Pharmageek
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Why Amazon Needs AI At The Center Of Its Healthcare Strategy

Why Amazon Needs AI At The Center Of Its Healthcare Strategy | La pharma dans tous ses états | Scoop.it
In December 2017, Amazon, JPMorgan Chase and Berkshire Hathaway announced the formation of a new healthcare company which would use technology to provide high-quality healthcare to patients and families more simply, and at a more reasonable cost. This move and rumors of entry into pharmaceutical distribution shook up stock prices for more established healthcare companies and pharmacy chains.

Amazon’s entry into healthcare is intriguing because medicine is ripe for disruption. In 2016, U.S. per-person healthcare expenses were $10,348, more than double that of other first-world countries that offer universal health coverage ($4,752 in Canada, $4,600 in France, $4,708 in Australia, and $4,192 in the UK). Despite these costs, U.S. medical care is not altogether accurate or safe; medical errors kill more Americans annually than AIDS and motor vehicle incidents. Yet somehow modern medicine has escaped large-scale reform from automation and systems engineering.

Amazon has the potential to change this market. Its decision is modeled after tech giants like Alibaba and Tencent, which have been experimenting with employee healthcare software in China for many years and whose initial targets included online medical advice, drug tracking systems and more recently, artificial intelligence.

However, if Amazon intends to succeed where other industry giants have failed, it is essential for it to build infrastructure that can leverage cutting-edge medical technologies. As the saying goes, "If you want something you have never had, you must be willing to do something you have never done." In 2018, this means Amazon needs to implement AI software for continuous analytics of automatically structured big data and advanced research technology.

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IBM Watson Health ranks top 15 hospitals #hcsmeufr #esante #digitalhealth

IBM Watson Health ranks top 15 hospitals #hcsmeufr #esante #digitalhealth | La pharma dans tous ses états | Scoop.it
The renamed Truven Health Analytics research initiative found that the highest performers achieved better care consistency and alignment across facilities.

Via Art Jones, Lionel Reichardt / le Pharmageek
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Art Jones's curator insight, April 24, 3:23 PM

Watson providing objective analysis to determine the best hospitals in the land.

 

Excerpt: Using the study’s findings, IBM Watson health said that if all Medicare inpatients received the same level of care as delivered by the top 15 systems, more than 60,000 lives could have been saved, more than 31,000 more patients could have a complication-free care episode, HAI’s would drop 16 percent and ER wait times would be reduced to 40 minutes or less.

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FDA approves primary care AI imaging device to detect eye disease in diabetics

FDA approves primary care AI imaging device to detect eye disease in diabetics | La pharma dans tous ses états | Scoop.it
Primary care physicians may now be able to identify moderate to severe levels of retinopathy in adult patients with diabetes using a recently FDA-approved artificial intelligence (AI) imaging device.

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La pharmacie française doit-elle avoir peur d’Amazon ?

La pharmacie française doit-elle avoir peur d’Amazon ? | La pharma dans tous ses états | Scoop.it
Ce n’est pas tant Amazon qui menace la pharmacie d’officine mais l’usager ! Car au final c’est bien lui qui mène la danse par l’adoption de nouveaux usages. Le client « BIOPAU© », pour Bavard, Impatient, Omnipotent, Partageur, Autonome et Unique, résume bien les exigences des nouveaux consommateurs à l’école du numérique[10].

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Les comptes de la sécurité sociale en 2017 s’améliorent de 2,7 milliards d’euros par rapport à 2016 - Ministère de la Santé

Les comptes de la sécurité sociale en 2017 s’améliorent de 2,7 milliards d’euros par rapport à 2016 - Ministère de la Santé | La pharma dans tous ses états | Scoop.it

Les comptes de la sécurité sociale en 2017 s’améliorent de 2,7 milliards d’euros par rapport à 2016 : Agnès BUZYN, ministre des Solidarités et de la Santé, et Gérald DARMANIN, ministre de l’Action et des Comptes publics, annoncent pour 2017 le plus faible déficit annuel de la sécurité sociale depuis 15 ans.


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Health Care In 2030: AI And The Shifting Role Of Your Pharmacist 

Health Care In 2030: AI And The Shifting Role Of Your Pharmacist  | La pharma dans tous ses états | Scoop.it
Healthcare is set to undergo some radical changes that will put your pharmacist at the center of your care.

Via Lionel Reichardt / le Pharmageek
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Des #médicaments imprimés en #3D sur des codes QR comestibles #esante #hcsmeufr 

Des #médicaments imprimés en #3D sur des codes QR comestibles #esante #hcsmeufr  | La pharma dans tous ses états | Scoop.it
Avec tous les progrès accomplis au quotidien dans le domaine de la santé, nous assistons aujourd’hui à l’avènement des soins personnalisés, comme avec les médicaments en 3D par exemple. Des chercheurs danois et finlandais ont mis au point une méthode pour imprimer des doses individuelles de médicaments sur un matériau comestible grâce à des motifs codés QR.

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MyPharmag's curator insight, February 26, 1:49 PM

Avec tous les progrès accomplis au quotidien dans le domaine de la santé, nous assistons aujourd’hui à l’avènement des soins personnalisés, comme avec les médicaments en 3D par exemple. Des chercheurs danois et finlandais ont mis au point une méthode pour imprimer des doses individuelles de médicaments sur un matériau comestible grâce à des motifs codés QR.

Coulmain Thierry's curator insight, February 27, 3:04 PM

Encore pour sourire et peut-être, être utile

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Alerte sur les retards d'accès aux médicaments innovants en France

Alerte sur les retards d'accès aux médicaments innovants en France | La pharma dans tous ses états | Scoop.it
Amgen alerte, dans un communiqué, sur les conséquences des difficultés d’accès aux médicaments innovants en France : plus de deux a
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China declared world’s largest producer of scientific articles

China declared world’s largest producer of scientific articles | La pharma dans tous ses états | Scoop.it
Report shows increasing international competition, but suggests that United States remains a scientific powerhouse.

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2017 FDA drug approvals

2017 FDA drug approvals | La pharma dans tous ses états | Scoop.it

The first-in-class monoclonal antibody (mAb) acts on both IL-4 and IL-13 signalling, modulating T helper 2-type responses, which are a unifying [...] anti-CD20 mAb rituximab held promise for the treatment of multiple sclerosis, but Roche did not


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Krishan Maggon 's curator insight, January 19, 11:37 AM
46 NCE/NME new drugs approved in 2017
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#Santé : Histoire et promesses des #médicaments #biosimilaires #hcsmeufr 

#Santé : Histoire et promesses des #médicaments #biosimilaires #hcsmeufr  | La pharma dans tous ses états | Scoop.it
Santé : Histoire et promesses des médicaments biosimilaires

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GIE_GERS's curator insight, January 10, 6:11 AM

Santé : Histoire et promesses des médicaments biosimilaires

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Amazon crée une nouvelle équipe "health & wellness" au sein de sa division Alexa

Amazon crée une nouvelle équipe "health & wellness" au sein de sa division Alexa | La pharma dans tous ses états | Scoop.it
Amazon souhaite aussi mettre à profit ses compétences reconnues dans le e-commerce et se lancer dans la distribution de médicaments. Même si ses ambitions dans ce domaine semblent assez floues, Amazon s'est déjà rapproché des laboratoires Mylan et Sandoz. Le géant du e-commerce souhaite-t-il se positionner comme un grossiste ou opter pour une démarche de distribution B2C ?
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Can the healthcare industry really expect to drive patient engagement?  #hcsmeufr #esante #digitalhealth

Can the healthcare industry really expect to drive patient engagement?  #hcsmeufr #esante #digitalhealth | La pharma dans tous ses états | Scoop.it
Increasing patient engagement as a tool for improving care and outcomes has been a tough code to crack for the healthcare industry. This is particularly true in comparison to the consumer engagement models adopted by companies such as Facebook, Amazon, and Netflix.
 
“It's unclear whether or not we'll ever achieve comparable levels of success,” said Paul LeVine, VP for analytic services for TrialCard, speaking at the Formulary, Copay and Access Summit in San Francisco April 11-12. During his presentation, “If patient engagement is the holy grail we all seek, what does it really provide us?,” he urged the time has come to adjust expectations and design targeted, timely, and simple interventions to address the inherent barriers to patient engagement.
 
“It is not necessarily a reasonable comparison to say we should be as good as Facebook,” LeVine explained. “We are never going to get that. If we can adjust our expectations, be smart, and design the kind of targeted approaches that play to our strengths and where the patient needs it the most, we are probably going to be better off.”
 
LeVine opened his presentation with a quote from Health Affairs that defines patient engagement: “Engagement generally captures the notion that patients are involved in the process of their care — actively processing information, deciding how best to fit care into their lives, and acting on their decisions.”
 
However, there is no universally agreed upon definition of patient engagement, which may be part of the challenge facing the healthcare sector. IBM cites 22 different reasons that compel patients to engage. These include health conditions, health cost planning, accessibility and availability, medical management, and social interaction. Athenahealth offers a more streamlined perspective: “Patient engagement is active collaboration between patients and providers.”
 
There is evidence the use of portals is increasing, LeVine noted. 
 
74% of patients are able to pay their bills through portals, compared to only 56% in 2013
45% of patients scheduled appointments through portals, compared to 31% in 2013
44% of patients now refill their prescriptions through portals, compared to only 30% in 2013
63% of patients communicate with providers through portals, compared with 55% in 2014
37% of portals provide patient-generated health data, versus 14% in 2013 
 
While the portal adoption rate is increasing, it is only when one compares it to engagement statistics from consumer platforms such as Facebook, Netflix, and Amazon that the disparity becomes clear. For example:
 
67% of Facebook users check the social media platform at least once daily (Statista, 2017)
23% of Netflix users stream something every day (Leichtman, 2017)
35% of Amazon Prime users shop on the site every week (Walker Sands, 2016)
 
“Those are some real engagement numbers,” said LeVine. “There are major issues to explore there.”
 
Patient versus consumer engagement

 

Patient engagement differs significantly from consumer engagement. One dilemma facing the healthcare industry is that patients' engagement is episodic by nature, noted LeVine. The consulting firm Deloitte identifies this in its 2015 consumer engagement report: Patients newly diagnosed are ravenous about finding out information about their condition, but that interest tails off once they are better educated. Similarly, functions such as choosing a PCP or a health plan – typical measures of engagement – are usually sporadic, rather than consistent ones.    
 
There are other hurdles to strong patient engagement, too. “Patients don't necessarily want to be reminded about their health condition. A lot of people want to push it away for a while and not be engaged,” explained LeVine.
 
Also, healthcare providers and payers have to be mindful of the unintentional impediments they put in the way of engaging with patients. LeVine cited a case in which a woman was listed as a having a high-risk pregnancy. She became “the designated high-risk pregnancy lady,” and every time she checked her portal those are the first words she would see. This type of labeling can be a strong deterrent to an individual's engagement with a payer's or provider's portal. 
 
The overarching question LeVine posed is, “Should we hold patient engagement to the same standard we use for consumer engagement?”
 
Despite some interesting outliers, there's generally strong support for promoting engagement. According to Health Affairs, patient engagement is one strategy to achieve the "triple aim" of improved health outcomes, better patient care, and lower costs.
 
In a study conducted by Judith Hibbard at the University of Oregon, patients with the lowest activation scores — those who had few skills and the lowest rate of confidence in actively engaging in their own care — incurred costs of up to 21% higher than patients with the highest activation levels.
 
“Given its inherent limitations, what would we consider ideal attributes of a ‘patient engagement' intervention?” LeVine asked.
 
He described a case study that looked into the inadequate use of co-pay cards and adherence. Conducted in 2016, the program used email and telephone interventions to re-engage diabetes patients. Using its QuickPath information platform, which connects HCPs, pharmacists, and payers with the patient through a variety of means, including smartphones, wearables, text, EHRs, and eWallet platforms, TrialCard was able to significantly improve the percentage of patients activating and using a co-pay card, from 19% to 34.5%.
 
Yet despite those improvements, LeVine believes more can be done. “We're still not reaching enough patients because our methods aren't fully aligned with the reasons for their lack of engagement,” he explained.
 
So how can payers and providers promote higher levels of activation from patients? LeVine pointed to the model used by the entertainment industry. For example, Netflix, he noted, has been highly successful in identifying consumer preferences and behavior through analytics. In fact, more than 80% of the movies and TV shows users watch on Netflix are discovered through the platform's recommendation system, LeVine said, citing an article from Wired
 
Netflix is not alone in using sophisticated analytics to improve engagement. According to McKinsey & Co., 35% of Amazon's revenue is generated by its recommendation engine.
 
“We need to get better behavioral analytics,” LeVine said. “These are the key models for understanding what motivates patients to act. We have to get a whole lot better at using some of those learning models (patient activation model, transtheoretical model, motivational interviewing, and others) as ways of improving that type of engagement.”
 
“The healthcare industry,” stressed LeVine, “is considerably less advanced in deploying these types of behavioral analytic strategies than the consumer sector – but that doesn't mean we don't know a lot about what motivates patient behavior. We just have more we need to learn.”

Via Plus91, Lionel Reichardt / le Pharmageek, VAB Traductions
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#Sérialisation du #médicament: le SNPHPU alerte sur des délais de mise en oeuvre trop courts dans les #pharmacies à usage intérieur (#PUI) #pharma #hcsmeufr 

#Sérialisation du #médicament: le SNPHPU alerte sur des délais de mise en oeuvre trop courts dans les #pharmacies à usage intérieur (#PUI) #pharma #hcsmeufr  | La pharma dans tous ses états | Scoop.it
Le Syndicat national des pharmaciens praticiens hospitaliers et praticiens hospitaliers universitaires (SNPHPU) s'inquiète des délais "courts" et "contraints" accordés pour la mise en oeuvre de la sérialisation du médicament dans les pharmacies à usage intérieur (PUI), dans une lettre adressée en avril à la ministre des solidarités et de la santé, Agnès Buzyn.

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GIE_GERS's curator insight, May 5, 4:00 AM

Le Syndicat national des pharmaciens praticiens hospitaliers et praticiens hospitaliers universitaires (SNPHPU) s'inquiète des délais "courts" et "contraints" accordés pour la mise en oeuvre de la sérialisation du médicament dans les pharmacies à usage intérieur (PUI), dans une lettre adressée en avril à la ministre des solidarités et de la santé, Agnès Buzyn.

Coulmain Thierry's curator insight, May 7, 12:45 PM

hormis l'aspect polémique de l'article, l'extrait ci dessus, que j'ai choisi ici, montre bien l'interêt de la sérialisation coté utilisateur (pharmacien)

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FDA Approvals in 2017 Represent a 21-Year High

FDA Approvals in 2017 Represent a 21-Year High | La pharma dans tous ses états | Scoop.it
In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high.

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Médicaments: les Français craignent contrefaçons et désertification - Sciencesetavenir.fr

Médicaments: les Français craignent contrefaçons et désertification - Sciencesetavenir.fr | La pharma dans tous ses états | Scoop.it
Les Français craignent en grande majorité que les contrefaçons de médicaments et les zones rurales dépourvues de pharmacies se multiplient, indique un sondage publié jeudi et commandé par la profession des répartiteurs pharmaceutiques.
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Could a pharma company shun sales reps and be successful?

Could a pharma company shun sales reps and be successful? | La pharma dans tous ses états | Scoop.it

Could there be a pharma, healthcare or life sciences company that decides to shun sales representatives?

Matt Lowe, pharma agency veteran and founder (just this week) of healthtech agency performance.io, believes that such a company, relying heavily on search and performance marketing, may be a possiblity in the next few years (albeit once somebody has the courage to take the leap).

I spoke to Lowe about what he has seen across pharma and healthcare marketing, and the skills that are currently lacking in the industry. He painted a picture of pharma companies that are "certainly patient centric, they just don’t always behave like it online." 

B2B and B2C are blurring

"The healthcare and life sciences industry needs to understand, I believe, that doctors are consumers like anyone else, and so are patients and carers and nurses and pharmacists," says Lowe.

He adds that though most people's first point of contact when looking for medical advice is a search engine [62% of UK patients], "currently pharma has this decentralised model - a plan gets handed out and it’s very much based on sales force and market access – understandably, because that model has delivered significant returns for many, many years."

Such an approach has to change if pharma is to keep up with agile tech companies. Lowe mentions Amazon and JPMorgan Chase, saying "they have digital woven into the fabric of how they operate - pharma doesn’t, so trying to be agile and define how it engages with audiences is going to be a slow process."

Patient-focused content will impact the bottom line

The process of building website infrastructure and online content is one where Lowe sees a breakdown in patient focus – he describes websites as "built based on the ambition, critical success factors, brand and strategic imperatives of the pharma company," but adding that "patients don't care about any of those things. They care about solutions when they need it most, whether it’s a stubbed toe or multiple myeloma."

"For the companies that have the most data on these solutions, the way they use that data is really bad. I get asked sometimes - ‘Do people want information from a big pharma company?’ - and I genuinely think people don’t care where the information comes from, if it’s well balanced, useful, relieves anxiety, or helps with the next best step."

This sort of content often benefits communities dealing with a particular condition, such as diabetes or cardiovascular problems, but Lowe asserts that the value of this approach for pharma also impacts on harder metrics, not just the softer ones.

"From a financial aspect," he says, "if people are better controlled then concordance is better (compliance, persistence, adherence) people stay on drugs longer, there's more effective up-titrating and it affects the P&L very positively."

Analytics and planning skills are lacking, for now

Pharma is stereotyped as being a laggard in some areas of digital. Though this is perhaps too easy an assumption to make, Lowe characterises the typical campaign or website build involving perhaps "a social listening exercise, maybe a keyword planner" but not truly understanding "insights informed infrastructure".

According to Lowe, marketers need to look at a slew of search and behavioural data and decide "what to avoid, what is useful based on semantic search behaviours, what kind of content is engaged with, on which platforms, with what frequency, and in which formats."

This type of activity will help set "domain strategy, url taxonomy, site structure, and onsite and offsite keywords", but according to Lowe the industry needs to recruit better skills in technology such as "tag management, advanced analytics, Google search console etc." 

Pharma needs to join the dots with performance marketing

Once campaigns and content are live, the next task is optimisation of performance marketing. Again, knowing how to track users and understand the success of content is key.

Lowe gives the example of event tracking, such as how many doctors are watching videos on up-titration of a complex medicine, or tracking consumers downloading a helpful PDF. Combining event tracking with acquistion through social media, and landing page optimisation is the kind of marketing industry standard conversion funnel that pharma needs to properly implement.

In order to do this, says Lowe, "investment in new people, new behaviours and new skills" is needed.

The rest of the world isn’t standing still

Many of these techniques of performance marketing are fairly well established now, but pharma marketers shouldn't be complacent and think that bringing their capability up to standard will be simple. Tech continues to evolve, with innovation such as blockchain creeping into paid media.

As ever, digital transformation is a journey, not an endpoint. Whether pharma needs its sales reps or not, the skillset for pharma marketers is changing.


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Amazon has quietly launched an exclusive line of over-the-counter health products

Amazon has quietly launched an exclusive line of over-the-counter health products | La pharma dans tous ses états | Scoop.it
Amazon has quietly launched an exclusive line of over-the-counter health products  
6:41 PM ET Tue, 20 Feb 2018 | 00:51
Amazon has quietly launched an exclusive line of over-the-counter health products in a possible challenge to pharmacy retail chains that could spark a price war and put pressure on store-brand profit margins.

Technically, the company doesn't own these products, which are produced by private-label manufacturer Perrigo, but it does put Amazon in a position to squeeze other retailers. The e-commerce giant launched the Basic Care line in August, including 60 products ranging from ibuprofen to hair regrowth treatment.
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Stratégie nationale de #santé : le changement à marche forcée #hcsmeufr #reforme #esante 

Stratégie nationale de #santé : le changement à marche forcée #hcsmeufr #reforme #esante  | La pharma dans tous ses états | Scoop.it
C’est parti pour les consultations sur la réforme du système de santé. Comme dans les autres axes de sa politique, le gouvernement veut aller vite. Trop vite ? Si tous les sujets importants semblent avoir été repérés par le ministère, les professionnels de la santé souhaitent en outre que les questions du financement, des regroupements territoriaux et des différentes formes de médecine soient aussi mises sur la table.

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GIE_GERS's curator insight, March 10, 3:43 AM

C’est parti pour les consultations sur la réforme du système de santé. Comme dans les autres axes de sa politique, le gouvernement veut aller vite. Trop vite ? Si tous les sujets importants semblent avoir été repérés par le ministère, les professionnels de la santé souhaitent en outre que les questions du financement, des regroupements territoriaux et des différentes formes de médecine soient aussi mises sur la table.

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Noms de marques des #médicaments > L’@ANSM publie ses recommandations : arrêt des « marques ombrelles » #sante #hcsmeufr #Pharma #officine #pharmacie 

Noms de marques des #médicaments > L’@ANSM publie ses recommandations : arrêt des « marques ombrelles » #sante #hcsmeufr #Pharma #officine #pharmacie  | La pharma dans tous ses états | Scoop.it
Afin de prévenir les risques potentiels liés au choix du nom des médicaments, l’ANSM a élaboré des “Recommandations à l’usage des demandeurs et titulaires d’autorisations de mise sur le marché et d’enregistrements relatives aux noms de médicaments”.
Le choix du nom d’un médicament n’est pas anodin et peut entraîner des risques pour les patients ou les professionnels de santé : confusion avec un autre médicament ou produit, erreur sur la population cible, les indications, la composition ou les modalités d’utilisation…
Afin de prévenir ces risques, l’ANSM, qui est notamment chargée d’examiner les noms proposés par les industriels dans leurs dossiers de demandes ou de modification d’autorisation de mise sur le marché (AMM), a élaboré des recommandations à leur intention.
Ces recommandations relatives aux noms des médicaments ont fait préalablement l’objet d’une large consultation publique sur le site internet de l’ANSM et d’un avis favorable à l’unanimité de la Commission d’évaluation initiale du rapport entre les bénéfices et les risques des produits de santé et de la Commission de suivi du rapport entre les bénéfices et les risques des produits de santé, lors d’une séance commune le 16 novembre dernier.
Dans ce cadre, les Commissions ont également auditionné les parties prenantes impliquées dans ce dossier. Ces auditions publiques diffusées en direct sont disponibles sur la chaîne Dailymotion de l’ANSM .
Les recommandations ont été établies en cohérence avec la ligne directrice publiée par l’Agence européenne des médicaments (EMA) et ont été soumises pour consultation à l’ensemble de parties prenantes concernées.
Elles rappellent les critères retenus par l’ANSM pour l’examen des noms des médicaments et proposent également des orientations nouvelles concernant, notamment, une recommandation d’expression du nom des médicaments génériques en dénomination commune (DC), un encadrement plus strict de la mention de l’arôme dans le nom, ainsi que l’arrêt de l’utilisation des « marques ombrelles » pour des produits de statuts différents ou pour des médicaments en prescription médicale facultative (PMF) ayant des compositions et/ou des indications différentes.
La publication de ces recommandations vise à garantir leur bonne application par les industriels et s’inscrit dans la volonté de l’Agence d’assurer l’homogénéité et la transparence de ses décisions et garantir la lisibilité de sa politique.

Via MyPharmag
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MyPharmag's curator insight, February 24, 3:27 AM

L’ANSM publie ses recommandations sur les noms des médicaments : l’arrêt de l’utilisation des « marques ombrelles » pour des produits de statuts différents ou pour des médicaments en prescription médicale facultative (PMF) ayant des compositions et/ou des indications différentes.

 

Afin de prévenir les risques potentiels liés au choix du nom des médicaments, l’ANSM a élaboré des “Recommandations à l’usage des demandeurs et titulaires d’autorisations de mise sur le marché et d’enregistrements relatives aux noms de médicaments”.

Afin de prévenir ces risques, l’ANSM, qui est notamment chargée d’examiner les noms proposés par les industriels dans leurs dossiers de demandes ou de modification d’autorisation de mise sur le marché (AMM), a élaboré des recommandations à leur intention.

Elles rappellent les critères retenus par l’ANSM pour l’examen des noms des médicaments et proposent également des orientations nouvelles concernant, notamment, une recommandation d’expression du nom des médicaments génériques en dénomination commune (DC), un encadrement plus strict de la mention de l’arôme dans le nom, ainsi que l’arrêt de l’utilisation des « marques ombrelles » pour des produits de statuts différents ou pour des médicaments en prescription médicale facultative (PMF) ayant des compositions et/ou des indications différentes.
La publication de ces recommandations vise à garantir leur bonne application par les industriels et s’inscrit dans la volonté de l’Agence d’assurer l’homogénéité et la transparence de ses décisions et garantir la lisibilité de sa politique.

Scooped by Pharmacomptoir / Corinne Thuderoz
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