Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

Pharma Marketing Network

MARCH 26, 2025

Artificial intelligence (AI) is no longer a futuristic concept in healthcareits here, embedded in nearly every touchpoint of modern pharma marketing. But as pharma marketers race to adopt these tools, a central question looms: Is AI fueling smarter engagement, or setting the stage for a compliance disaster?

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Compliance Marketing Regulation Pharma Companies 52

BioPharma Reporter

MARCH 19, 2024

With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.

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Regulation Production Drugs Marketing 98

Bio Pharma Dive

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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Drugs Regulation Production Marketing 198

STAT News

FEBRUARY 3, 2023

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Read the rest…

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Regulation Production Containment Marketing 98

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. One of the reasons for such bad TV is the lack of talent within DTC marketing. It’s estimated that DTC marketers spend 76% of their budgets on TV ads. Agencies are equally responsible for bad DTC TV.

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Contamination Production Marketing Drugs 297

Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Last month, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorisation for SKYCovione to prevent Covid-19 resulting from SARS-CoV-2 infection in people aged 18 years and above.

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Vaccination Vaccine Protein Clinical Trials 363

Camargo

JANUARY 27, 2021

The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation. Where is the regulation found? 21 CFR §814 Subpart H.

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Production Drugs Marketing Regulation 138

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Regulation Production Life Science Drugs 133

pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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Regulation Production Development Sales 122

STAT News

DECEMBER 19, 2022

WASHINGTON — The Food and Drug Administration’s Center for Tobacco Products is lacking clear goals — and that lack of vision is hampering its ability to regulate millions of tobacco products currently on the market, according to an external review of the center released Monday.

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Regulation Marketing Production Drugs 98

Camargo

OCTOBER 20, 2021

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Such products require more complex target profiling. Such products require more complex target profiling. Definition of Combination Products.

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Production Regulation Drugs Development 206

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health.

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Marketing Compliance Production Doctors 130

Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds.

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Drugs Manufacturing Production Marketing 298

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

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Regulation Manufacturing Production Marketing 189

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials 189

Trials Clinical Trials Clinical Trials Drugs 189

Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). A key natural regulator, NRF2 controls antioxidant genes’ expression.

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Development Gene Expression Licensing Licensing 264

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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Marketing Sales Manufacturing Drugs 173

NPR Health - Shots

NOVEMBER 29, 2022

The FDA seems poised to at last yank some products aimed at teens from the market. The advent of vaping revived nicotine addiction among young people after a dramatic decline. Will it work? Image credit: Helen H. Richardson/Denver Post via Getty Images)

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Regulation Production Marketing 134

Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

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Production Drugs Marketing In-Vitro 130

Camargo

MAY 19, 2021

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.

Production 142

Production FDA Approval Marketing Drugs 142

Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion Market Demand appeared first on Pharma Mirror Magazine. billion by 2023.

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Clinical Trials Clinical Trials Gene Marketing 130

Pharmaceutical Technology

DECEMBER 8, 2022

According to the revised deal, Daiichi Sankyo and Kite will transfer the Marketing Authorization for Yescarta to Gilead’s Japan subsidiary, Gilead Sciences K.K., The therapy’s sales and promotion works in Japan following the transfer of marketing authorisation will be carried out by the Kite Cell Therapy Business Unit at Gilead Sciences K.K.

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Licensing Licensing Gene Therapy Gene 305

World of DTC Marketing

OCTOBER 4, 2021

Earlier this year, I was asked by a client to write a position paper on using Facebook for the DTC marketing of an oncology product. From my estimates, most of it failed because pharma companies are afraid of misinformation concerning regulations around DTC marketing.

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Branding Marketing Pharmacy Pharma Companies 224

FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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Regulation Medicine Doctor Doctors 114

Pharma Marketing Network

MARCH 17, 2025

With increasing competition and stricter compliance regulations, pharma marketing teams must adopt data-driven and personalized marketing strategies to capture the attention of HCPs. But how can pharma brands stand out in a crowded market? For expert guidance on pharma marketing trends, visit Pharma Marketing Network.

Branding 52

Branding Marketing Compliance Pharma Companies 52

World of DTC Marketing

FEBRUARY 7, 2022

According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial approval of Aduhelm for Alzheimer’s. Finally, they need to withdraw Aduhelm from the market.

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Pharma Companies Marketing Sales Clinical Trials 253

Pharma Marketing Network

DECEMBER 31, 2024

Table of Contents Sr# Headings 1 Introduction: The Pharma Marketing Challenge 2 Building a Winning Pharma Marketing Strategy 3 The Role of Branded Drug Campaigns 4 Innovating for Future Success Introduction: The Pharma Marketing Challenge Marketing pharmaceuticals is no small feat.

Marketing 52

Marketing Branding Compliance Drugs 52

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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Marketing Compliance Regulation Drugs 97

XTalks

JULY 7, 2023

Earlier this week, the World Health Organization (WHO) released new guidelines that emphasized the critical role that marketers must play in safeguarding children’s health. The WHO underscored the need for tighter regulations to protect children from the adverse effects of food marketing.

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Marketing Production Regulation Branding 97

Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

Production 130

Production Drugs In-Vitro Containment 130

Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales.

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Sales Marketing Branding Production 98

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. They can assist with analytical method development and validation, stability testing, and characterization of drug substances and products.

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Compliance Manufacturing Production Regulation 98

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. It can be used as a monotherapy or along with cholesterol-lowering medicines. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

World of DTC Marketing

MARCH 6, 2022

The excitement about these technologies partially stems from their potential to address health care system challenges that have slightly improved with traditional health care processes, payment models, regulations, guidelines, and innovations such as drugs and devices. What about patients?

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Production Doctor Doctors Branding 244

Camargo

SEPTEMBER 8, 2021

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device.

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Development Regulation Production Drugs 186

Pharma Marketing Network

JULY 12, 2023

The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. They are individuals with unique needs, concerns, and experiences.

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Marketing Compliance Regulation Branding 98