Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage. The quality and purity of these ingredients can greatly impact the final product's efficacy and safety.

Generic Drugs 73

Generic Drugs Production Compliance Drugs 73

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…

Regulation 98

Regulation Production Containment Marketing 98

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.

Production 138

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.

Regulation 133

Regulation Production Life Science Drugs 133

Pharma Marketing Network

APRIL 11, 2025

In a highly regulated industry like pharmaceuticals, standing out online can feel like navigating a maze. This is where SEO marketing strategies become essentialallowing brands to boost visibility, earn trust, and support both HCP and patient journeys without violating regulatory guidelines.

Marketing 52

Marketing Branding Regulation Production 52

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

Regulation 122

Regulation Production Development Sales 122

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.

Production 206

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.

Marketing 130

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.

Drugs 298

Drugs Manufacturing Production Marketing 298

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The […].

Regulation 189

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.

Development 264

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.

Marketing 173

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)

Regulation 134

Regulation Production Marketing 134

Pharmaceutical Technology

DECEMBER 20, 2022

To assess the system’s real-world performance, eight different end users across various locations combined and analyzed product data after using the SA25 workcell. The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well. Moving forward.

Regulation 130

Regulation Contamination Manufacturing Production 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

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.

Licensing 305

Licensing Licensing Gene Therapy Gene 305

Drug Patent Watch

APRIL 8, 2025

Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation. Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs.

Pharma Companies 52

Pharma Companies Generic Drugs Production Regulation 52

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.

Branding 224

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.

Regulation 114

Regulation Medicine Doctors Doctor 114

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.

Pharma Companies 253

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.

Marketing 97

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.

Marketing 97

Marketing Production Regulation Branding 97

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

Marketing 130

Marketing Antibody Licensing Licensing 130

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

Production 230

Production Packaging Packaging Development 230

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.

Sales 98

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.

Compliance 98

Compliance Manufacturing Production Regulation 98

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?

Production 244

Production Doctors Doctor 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.

Development 186

Development Regulation Production Drugs 186

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

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.

Marketing 98

Marketing Compliance Regulation Branding 98

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharma Mirror

NOVEMBER 7, 2023

Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products.

Compliance 130

Compliance Regulation Manufacturing Production 130

Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. This trade has been able to continue for the most part, as the UK’s regulator (the MHRA) remains aligned in many areas with the EU’s regulator (the EMA).

Medicine 290

Medicine Production Generic Drugs Regulation 290

Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Regulations can be challenging, with ever-changing rules. And accurate labelling and translation are critical for this sector.

Medicine 130

Medicine Production Packaging Packaging 130

Pharmaceutical Technology

MAY 2, 2023

FirstLine® is Datwyler’s most advanced manufacturing standard and production environment, combining new levels of quality and innovation with guaranteed reliability. The discovery of large quantities of nitrosamines in many drugs has led to a high number of product recalls, and new regulatory guidelines have quickly followed.

Packaging 130

Packaging Packaging Production Contamination 130