FDA | pharma naming

FDA approves first automated insulin delivery device for type 1 diabetes

FDA / US Food and Drug Administration

3 min read

FDA approves first automated insulin delivery device for type 1 diabetes

The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device...

What's the Prescription for a Perfect Name?

By Paul Norman / Pharmaceutical Executive Europe

7 min read

What's the Prescription for a Perfect Name?

With Viagra and Prozac rivaling McDonald's and Coca-Cola among today's most frequently used brand names, it's no surprise that...

India’s Drug Approvals Near Record Despite FDA Inspection Blitz

by Ari Altstedter and Manish Modi / Bloomberg

3 min read

India’s Drug Approvals Near Record Despite FDA Inspection Blitz

Even as the FDA has increased scrutiny of India, it’s been approving generic drug applications from the country’s firms at a record pace....

FDA issues draft guidance on nonproprietary naming of biosimilars

Healio.com

2 min read

FDA issues draft guidance on nonproprietary naming of biosimilars

The FDA announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products....

Delay of drug labeling policy can make generic drugs more dangerous

By Tara Culp-Ressler / Thinkprogress

4 min read

Delay of drug labeling policy can make generic drugs more dangerous

Several Americans who say they’ve been dangerously harmed by generic drugs — and were unaware of the risk because the drug maker did not...

Featured Posts

How sustainable are branded generics?

Branded generics are delivering great growth and profitability in emerging markets, but how much longer can they continue to do so? A new...

Drug Name Confusion: why you need professional naming

original article by Kathleen Doheny on Medscape Medical News / Drug Name Confusion: More Than 80 New Drug Pairs Added to the List -...

How drugmakers come up with evocative brand names like Viagra and Lunesta

There’s an art and a science to naming pharmaceutical drugs. When you pick up a prescription of Viagra, Lunesta, Advair, or Paxlovid, you...

Help to find a new name for the monkeypox virus

A group of global experts convened by WHO has agreed on new names for monkeypox virus variants, as part of ongoing efforts to align the...

How Do Drugs Get Named?

Drug names are the product of complex, multiparty negotiations in which the needs and desires of various stakeholders (patients,...

Sanofi launches Impact® brand of medicines for low-income countries

Sanofi Global Health ⁠— a nonprofit unit of Sanofi set up in 2021⁠ — has launched Impact®, a new brand of standard of care medicines...

Branded Generics: What They Are and Why They’re Profitable

Branded generic drugs attach proprietary names to generic drug molecules and may be marketed similarly to how branded drugs are. picture...

The top 20 drugs by worldwide sales in 2021

It took a global pandemic to end the nine-year reign of AbbVie’s Humira as the world’s best-selling pharmaceutical product—and the final...

Drug submissions: Procedures to reach regulatory approval

Before a new drug or biologic can go to market, a drug submission must be compiled and filed with all relevant regulatory agencies to...

How pharmaceutical names influence the way consumers and doctors view medicines

Does the way pharmaceuticals are named matter when it comes to consumer and healthcare providers? The FDA wants to find out. Although the...

All in a name: safety first

Most companies when naming a drug want to use something catchy and simple, which will not confuse doctors or patients and maintain safety...

Drug Name Development: Regulatory Changes You Need to Know

Naming your asset – or more specifically, navigating the regulatory obstacles and variables of gaining name approval – is critical to...

Drug repurposing and skinny labels

Generic drug manufacturers obtain FDA approval for non-patented indications by carving out from its label any approved use that is still...

Pharma product launch optimisation tool

US — Vivisum has launched Brand Builder, a solution that provides strategic market insight for pharmaceutical brands. Brand Builder...

Naming Your Brand

In a crowded field, how to choose a name real enough to please the feds and original enough to differentiate your product Choosing a name...

Biosimilar Naming Policy Will Help Ensure Patient Safety and Transparency

The American College of Rheumatology (ACR) today praised the Food and Drug Administration (FDA) for issuing draft guidance requiring...

How does the FDA 'approve' medical products?

You may have seen medical products that claim to be "FDA cleared," "FDA registered," "FDA listed" or "FDA approved" - but what do these...

The Secret Formula Behind Every Drug Name

Most people have no problem with famous names like Enbrel®, Prozac®, and Viagra®. But when it comes to understanding new drug names, such...

Branding and design in the medical/pharma industry

Communication is often seen as a touchy subject when it comes to the healthcare sector, given the tight regulations and fierce...

Pharma Brand Strategy 2.0

Learn about the building blocks of a great brand strategy that will have the potential to capture the full commercial value from a...

What Is an Active Pharmaceutical Ingredient (API)?

The Active Pharmaceutical Ingredient (API) is the part of any drug that produces the intended effects. Some drugs, such as combination...

The Drug Naming Process

Drugs often have several names. A marketed drug may have up to four different types of names: a chemical name, a company name, a generic...

The twists and turns of naming diseases

When a new disease is identified in a group of patients it needs a name so it can be described, researched and treated. But, unlike...

Branding: When One is Not Enough

Launching a second brand is a marketing strategy to address an unmet need distinct from the current brand. In the pharmaceutical industry...

Liposomal medicine names to be changed to avoid errors

The EMA has requested that liposomal medication names be changed to avoid the risk of confusion. All marketing authorisation holders of...

The difference between pharmaceutical and biotechnology

While sitting in a meeting recently I was asked, 'what exactly is the difference between pharma and biopharma?' For most of us, we may...

Biosimilar names may affect pharmacist dispensing habits

How biosimilars are named could influence the willingness of pharmacists to substitute such drugs for more expensive biologics, a survey...

Branders give products an identity

In the world of branding, there's a language all its own: Casodex, Grazax, Latisse, Symbicort and Vusion. Each one of those words is the...

The top 10 drugs of 2024

EvaluatePharma analysts predict AbbVie's Humira will top pharma's sales charts in 2024, followed by Merck's Keytruda and Celgene's...

FDA Draft Guidance Requiring Distinct Naming for Biosimilars

Biosimilar Naming Policy Will Help Ensure Patient Safety and Transparency ATLANTA – The American College of Rheumatology (ACR) today...

A drug by any other name would work just as well — making sense of drug names

How are drugs named, and how do names aid in prescription and generic substitution? In William Shakespeare's play Romeo and Juliet,...

FDA Approves First Sensor Pill to Alert Doctors When It’s Ingested

The U.S. Food and Drug Administration (Silver Spring, MD) has approved a pill that includes a sensor that digitally tracks if patients...

Can you teach old drugs new tricks?

Faced with skyrocketing costs for developing new drugs, researchers are looking at ways to repurpose older ones — and even some that...

'Accelerated approval' drugs: How well are they studied?

When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and...

The FDA just approved the first direct competitor to a billion-dollar cancer drug

As it stands right now, biosimilars can't be used interchangeably with branded versions, meaning if you were to get a prescription for a...

Role of brand is 57% more likely to influence a recommendation compared to two years ago

A new report conducted by health branding agency InterbrandHealth measures the value that brands alone provide pharmaceutical companies....

What’s in a name? Billions of dollars in tech costs for biosimilars

A new US FDA guidance on how biological products licensed under the Public Health Service Act (PHS Act) need to be named is playing havoc...

How drug development is speeding up in the cloud

Developing a drug from a promising molecule to a potential life-saver can take more than a decade and cost billions of dollars. Speeding...

Globalization in the pharmaceutical industry

Where are drugs invented, and how can easily innovation be seeded in new areas? This is the first of DrugPatentWatch's publications...

Why Biosimilar Drug Names Contain Unhelpful Gibberish

Have you ever wondered how drugs are named? Is there ever a discernible meaning behind drug names? Who manages this mess anyway–drug...

Behind potent drug names, a complex mix of ingredients

Firms must navigate legal and linguistic hurdles for approval They are the public face of products that can take many years and hundreds...

Introducing The New Association For Accessible Medicines (AAM)

The Generic Pharmaceutical Association (GPhA), the US largest trade group representing generic pharmaceutical and biosimilar companies,...

FDA Reiterates Decision on Suffixes in Biosimilar Naming

A Federal Register notice from FDA addressed comments on the guidance on Proprietary Naming of Biological Products and the agency’s...

Behind potent drug names, a complex mix of ingredients

Drug names start out as alien words: random collections of syllables that can sometimes seem almost as mind-boggling as the complicated...

New diagnostic name for stigmatizing term obesity

The American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) proposed Adiposity-Based Chronic...

The creative science of coining drug names

With more than 30,000 proprietary drugs in the United States alone, coming up with a unique brand name is no easy task. Cialis, Eliquis,...

UK medicines regulation: responding to current challenges

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have...

Probiotics in Favor of Life

We all use the term “probiotic" so often, but may not think of what it means. The Russian Nobel Laureate Elie Metchnikoff, best known for...

Maintaining Relevance In The Age Of Consumerism: Lessons From The Healthcare Industry

The rise of global consumerism has shifted the healthcare landscape tremendously. People expect sophisticated levels of transparency and...

'Creation engineering': The art and science of naming drugs

CNN)Yearly lists of the "most popular baby names" show how tastes change over time. While Jennifer, Heather, Michael and Jason may have...

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