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FDA Approves Zarxio, First Biosimliar Drug - New York Times

FDA Approves Zarxio, First Biosimliar Drug - New York Times | pharmabranding | Scoop.it
The approval paves the way for alternatives to an entire class of complex and costly drugs to go on the market.
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products, but until now biosimilar drugs have been insulated from the competition of cheaper copies. The FDA has now finally approved the first biosimilar for use on the American market. A quite significant decision as it opens the door to a new class of potentially cheaper drugs made using living cells and not synthesized from chemicals like typical drugs.

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Actavis Plans Corporate Name Change to Allergan - Drug Discovery & Development

Actavis Plans Corporate Name Change to Allergan - Drug Discovery & Development | pharmabranding | Scoop.it
Actavis will change the company name after the completed acquisition of Allergan.
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Actavis, the world's third-largest generics prescription drug manufacturer, also markets a broad portfolio of branded pharmaceuticals and is developing and marketing biosimilars. After the acquisition of Allergan, producer of the successful Botox, Actavis announced that it intends to use the Allergan name as its corporate name and for its global branded pharmaceutical portfolio, and will retain the Actavis name for select geographic regions and product portfolios.

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FDA Tries to End Dispute Between Brand-Name and Generic Drug Makers - Wall Street Journal (blog)

FDA Tries to End Dispute Between Brand-Name and Generic Drug Makers - Wall Street Journal (blog) | pharmabranding | Scoop.it

The FDA is trying to bring brand name and generic drugmakers together after vociferous complaints from generic drug makers that their brand-name counterparts have been exploiting an FDA risk-mitigation program, which is designed to boost patient safety, in order to thwart generic competition.

The FDA has issued a so-called draft guidance that provides a road map for generic companies to obtain samples of medicines from brand-name rivals for product testing.
Michael Dijkstra Taurel, Globrands health & pharma's insight:

The FDA is trying to bring brand name and generic drugmakers together after vociferous complaints from generic drug makers that their brand-name counterparts have been exploiting an FDA risk-mitigation program, which is designed to boost patient safety, in order to thwart generic competition.

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Putting our lives in their brands - The Guardian

Putting our lives in their brands - The Guardian | pharmabranding | Scoop.it
What if brand loyalty was actually as serious as life and death? Nick Dutnall looks at how we might trust a brand with our lives
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Can doctors permit themselves to be brand loyal? So what can a well chosen brand name add to their prescription behaviour?

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French plan to push copycat biotech drugs worries Big Pharma - Chicago Tribune (blog)

French plan to push copycat biotech drugs worries Big Pharma - Chicago Tribune (blog) | pharmabranding | Scoop.it
French plan to push copycat biotech drugs worries Big Pharma Chicago Tribune (blog) The government quietly introduced the measure allowing pharmacists to substitute prescribed brand-name biotech drugs with cheaper, similar versions in its 2014...
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Copying biosimilar drugs is set to grow as more patents expire or are successfully challenged, but up till now health care insurers and countries only encourage the use of cut-price biosimilars but don’t force to prescribe them. France is the first European country to push the use of cheap copies of biotech drugs to pursue biologic substitution in an attempt to get a grip on the rising healthcare costs by permitting pharmacy substitution.

Michael Dijkstra Taurel, Globrands health&pharma naming

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How Big Pharma is "humanising" its brands - PharmaTimes

How Big Pharma is "humanising" its brands - PharmaTimes | pharmabranding | Scoop.it
How Big Pharma is "humanising" its brands PharmaTimes Major pharmaceutical companies are beginning to embrace the “brand personality” marketing strategy traditionally employed by consumer-focused companies such as Apple, Coca-Cola and...
Michael Dijkstra Taurel, Globrands health & pharma's insight:

What can pharma brands learn from fmcg brands in their battle against private labels and generics?

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What's in a name? Just about everything - The National

What's in a name? Just about everything - The National | pharmabranding | Scoop.it
What's in a name? Just about everything
The National
Nigerian pharmaceutical companies have been successful in building brand identity in the country.
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Drug patent cliff to drive pharma firms into innovation, research - BusinessDay

Drug patent cliff to drive pharma firms into innovation, research - BusinessDay | pharmabranding | Scoop.it
Drug patent cliff to drive pharma firms into innovation, research BusinessDay The generic drug industry covers the marketing and sale of medication containing the same active ingredients and dosages as brand-name drugs manufactured by the...
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Novartis and Merck: “Wanna Trade?” Companies Propose to Swap Businesses - Wall St. Cheat Sheet

Novartis and Merck: “Wanna Trade?” Companies Propose to Swap Businesses - Wall St. Cheat Sheet | pharmabranding | Scoop.it
Novartis and Merck: “Wanna Trade?” Companies Propose to Swap Businesses
Wall St.
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Utrecht Centre of Excellence for Affordable Biotherapeutics - Universiteit Utrecht

Utrecht Centre of Excellence for Affordable Biotherapeutics - Universiteit Utrecht | pharmabranding | Scoop.it
Michael Dijkstra Taurel, Globrands health & pharma's insight:

The Utrecht University and the World Health Organization (WHO) will work together to provide affordable patent free medicines in developing countries. Both organisations signed an agreement on March 2 in which the University makes its relevant knowledge available for the production of such medicines in The Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health (“UCAB”).

UCAB's mission is to improve global health by helping to make high quality and affordable biotherapeutics accessible to patients throughout the world in a sustainable fashion.

The first project, respiratory syncytial virus (RSV) is the leading cause of hospitalisations in infants and young children and the leading cause of acute lower respiratory infections (ALRI) in children globally. The annual global incidence of RSV infection has been estimated at 64 million and is estimated to cause approximately 33.8 million new episodes of ALRI in children annually, of which 96% occur in developing countries.

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Update on pharmaceutical brand name requirements in Canada - Lexology (registration)

Update on pharmaceutical brand name requirements in Canada - Lexology (registration) | pharmabranding | Scoop.it

In an effort to standardize the brand name review process, Health Canada released a new Guidance Document for Industry – Review of Drug Brand Names, which replaces the 2013 Draft Revised Guidance Document for Industry – Review of Drug Names for Look-Alike Sound-alike (LASA) Attributes. The new Guidance will come into effect on June 13, 2015.Sponsors filing a drug submission must also provide a brand name assessment as part of the drug safety and effectiveness evaluation. The objective of…

Michael Dijkstra Taurel, Globrands health & pharma's insight:

In an effort to standardize the brand name review process, Health Canada released a new Guidance Document for Industry – Review of Drug Brand Names, which replaces the 2013 Draft Revised Guidance Document for Industry – Review of Drug Names for Look-Alike Sound-alike (LASA) Attributes. The new Guidance will come into effect on June 13, 2015.

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Camargo Launches New Brand at GPhA as 505(b)(2) Development Continues ... - Business Wire (press release)

Camargo Launches New Brand at GPhA as 505(b)(2) Development Continues ... - Business Wire (press release) | pharmabranding | Scoop.it
Camargo Pharmaceutical Services, will reveal its new brand at the Generic Pharmaceutical Association (GPhA) Annual Meeting.
Michael Dijkstra Taurel, Globrands health & pharma's insight:

The FDA 505)b)(2) application

A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method gains approval for new drugs in a fraction of the time and cost required by traditional paths. In the fiscal year 2006, approximately 20% of new small molecule drugs were approved through the 505(b)(2) process; two years later, more than half of the new small molecule drugs approved in the United States were based on this strategy. Judging from the rate at which the Investigational New Drug (IND) applications are filed today, the percentage of 505(b)(2) approvals will be greater than 80% within the next few years. The reasons behind the remarkable success of 505(b)(2) are twofold. Because approval can rest in part on data already accepted by the FDA or otherwise available in the public domain, fewer and smaller studies may be required, thus mitigating costs and shortening development time. Unlike generic drugs approved under Section 505(j) where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five or even seven years of market exclusivity, depending on the type of clinical data included in the NDA.

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Making medicine emotional - Medical Marketing and Media

Making medicine emotional - Medical Marketing and Media | pharmabranding | Scoop.it
Medical Marketing and Media
Making medicine emotional
Medical Marketing and Media
How can pharma brands be “more human?
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Brands can personify a tangible thing into something powerfully intangible. A strong brand decommoditizes a commodity because it lives in our heads and in our hearts. 

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A guide for international pharmaceutical communications: What do we really mean by brand value? (Part 1)

A guide for international pharmaceutical communications: What do we really mean by brand value? (Part 1) | pharmabranding | Scoop.it
Sunil Ramkali presents some key insights on how to deliver a brand that truly addresses market needs in the pharmaceutical industry. Is developing differentiated brand communications that deliver real world value and drive brand uptake your goal?
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Pharmamerken realiseren zich steeds meer dat in de strijd tegen de generics ieder marketingtool dat benut kan worden ook daadwerkelijk benut moet worden, waarin de merknaam een prominente rol speelt.

Geen vage voor de gebruikende patient nietszeggende merknamen meer, maar een aansprekende merknaam die herkenning oproept en na het aflopen van het patent zijn waarde blijft houden en zo de aanval van de generics langer kan weerstaan. 

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As biosims win nods in Europe and India, debate over naming rights ...

As biosims win nods in Europe and India, debate over naming rights ... | pharmabranding | Scoop.it
What's in a name? In the pharmaceutical world, the answer to this question is no simple matter. Drugmakers, biotechs and their generic rivals are squabbling over the names that will be assigned to biosimilars, in a battle for a marketing edge.
Michael Dijkstra Taurel, Globrands health & pharma's insight:

Should biosimilars have the same International Proprietary Names or unique, non-proprietary, or generic names to distinguish the medicines from the original biologics?

Read more: As biosims win nods in Europe and India, debate over naming rights heats up - FiercePharma http://www.fiercepharma.com/story/biosims-win-nods-europe-and-india-debate-over-naming-rights-heats/2014-01-29#ixzz2rrv6dDDC ;

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What's in a name? Just about everything - The National

What's in a name? Just about everything - The National | pharmabranding | Scoop.it
What's in a name? Just about everything
The National
Nigerian pharmaceutical companies have been successful in building brand identity in the country.
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Why Don't You Trust Generic Drugs as Much as Brand Name ...

Why Don't You Trust Generic Drugs as Much as Brand Name ... | pharmabranding | Scoop.it
... and Administrative Pharmacy, Nov-Dec, 2012). A different study found that many people perceive generic medicine as less potent and not as good as "the real medicine" (Preventing Chronic Disease, online Aug.
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Trade-name Drugs vs. Generic Drugs | Health Article Directory

The difference between these two versions is that brand-name medication is manufactured by a certain pharmaceutical company that held a patent on the drug. Having a patent on particular medicine implies that other ...
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