Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

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Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Finding the best commercial packaging suppliers in contract marketing.

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Packaging Packaging Marketing Containment 100

XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

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XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

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Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

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XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers.

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Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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Regulation Compliance Contamination Marketing 52

FDA Law Blog

FEBRUARY 13, 2025

While a PCCP can address many types of post-market device changes, FDA specifically recognizes that software development is an iterative process, and software developers continually try to improve and update devices.

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Pharmaceutical Technology

MAY 24, 2023

The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial.

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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pharmaphorum

JUNE 16, 2021

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. They point out that consumers can make it more difficult to be tracked by disabling advert identifiers, adjusting app permissions, and using advert blockers.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R. Design controls (21 C.F.R.

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Compliance Marketing Regulation Development 98

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. The vaccine is top of the list of 35 potential coronavirus vaccines in clinical development, according to a list maintained by the World Health Organization.

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World of DTC Marketing

MAY 24, 2022

In a review of 52 apps for anxiety , an international team of psychologists found that sixty-seven percent had been developed without any guidance from a healthcare professional. It means that mental help apps and services must be tightly regulated and reviewed. Does this mean we should give up?

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XTalks

OCTOBER 13, 2023

The magic lies in its patented De-Sugaring technology developed by NTFC. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Impressively, this sugar free cranberry juice retains every bit of the fruit’s nutritional value. Sugar is ubiquitous.

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Containment Production Marketing Branding 105

XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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Vaccination Vaccine Production Manufacturing 105

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Integrated analytical services for pharmaceuticals.

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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness 2 ,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.

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Clinical Development Medicine Development Containment 52

Camargo

MAY 19, 2021

The HUD designation provides an incentive for sponsors developing medical devices to be used in the treatment or diagnosis of diseases affecting small populations. CFR – Code of Federal Regulations Title 21. Timeline and Maintenance. The FDA should respond to the request within 45 days. Author: Marissa Berry, PhD, RAC.

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WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. If the objectives of the study contain a health claim the substance being studied will be considered a drug and the FDA likely will require an IND.

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XTalks

JANUARY 12, 2022

“One of the most efficient ways to enhance food safety and reduce spoilage and waste is to develop efficient biodegradable non-toxic food packaging materials.”. According to the US Environmental Protection Agency (EPA), plastic containers and packaging make up a major portion of municipal solid waste, accounting for 82.2

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Packaging Packaging Scientist Bacteria 98

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. Timely intervention is imperative to contain and mitigate potential impact.

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The Pharma Data

NOVEMBER 2, 2020

The biotechnology production development program commenced in October 2020 with completion expected in September 2021. “Our goal is the development of precise and predictable psychedelic drug formulations for clinical study and therapeutic use.” “Psychedelic agents are a promising new class of therapeutic drug.

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XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis.

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FDA Approval Development Containment Licensing 98

pharmaphorum

MAY 5, 2022

We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data that is as accessible as it is illuminating” ( CDISC , 2021).

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XTalks

AUGUST 26, 2024

Supermarket baby food is often a critical aspect of early childhood development. A recent study published in the journal Nutrients highlights significant concerns, revealing that many baby foods contain excessive amounts of sugar and salt, coupled with misleading marketing claims.

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Containment Production Regulation Protein 52

pharmaphorum

MARCH 4, 2021

The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis. In a separate development, Israel-based Azura Ophthalmics said its potential dry eye drug AZR-MD-001 hit its target in a phase 2 trial, paving the way for further development.

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The Pharma Data

AUGUST 18, 2020

Johnson & Johnson statement on the launch of new CARE (Corona Accelerated R&D in Europe) consortium, Europe’s largest, multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19. The reader is cautioned not to rely on these forward-looking statements.

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