European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

Pharmaceutical 82

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products 82

World of DTC Marketing

MARCH 10, 2022

market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. billion last year, the highest total for any pharmaceutical product and they will do anything to keep that money. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”.

Prescription 205

Prescription Pharmaceutical products Pharmaceutical Manufacturing 205

European Pharmaceutical Review

APRIL 27, 2023

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

Manufacturing 76

Manufacturing Food and Drug Administration Pharmaceutical products Food 76

PM360

SEPTEMBER 7, 2023

Therapeutic Talk: Doctors’ Reactions to Recent FDA Approvals in Respiratory, Gastro, Infectious Disease, and More The number of times HCPs mentioned new products approved by the FDA over the course of the month of May. The most shared links by HCPs were for Arexvy , Rinvoq , and Inpefa.

Healthcare 52

Healthcare Healthcare FDA Doctors 52

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

European Pharmaceutical Review

JANUARY 26, 2023

The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review. The draft ICH M10 guideline was published for comments in 2019.

Food and Drug Administration 87

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 87

European Pharmaceutical Review

AUGUST 23, 2022

1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. 2 The global counterfeit pharmaceuticals trade is estimated to be worth billions annually, 3 bolstered significantly by the increased illicit online pharmacies that emerged during the COVID-19 pandemic. This allows for a cyber?physical All protein?based

Medicine 90

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 90

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Internet] [link].

Food and Drug Administration 73

Food and Drug Administration Pharmaceutical products FDA Pharmacology 73

European Pharmaceutical Review

MARCH 27, 2024

In turn, this impedes growth of the market because of the resulting delay in product approvals. The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor.

Safety 68

Safety Marketing Food and Drug Administration Pharmaceutical 68

European Pharmaceutical Review

MAY 17, 2023

QMS are the integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured and distributed in compliance with regulatory requirements and meet the desired quality standards. This is compared to a value of $1.48 billion in 2022.

Management 79

Management Marketing Manufacturing Pharmaceutical 79

Pharmaceutical Technology

DECEMBER 14, 2022

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration Pharmaceutical products FDA Marketing 59

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

InCrowd

JUNE 13, 2023

Adoption of Newly-Approved 1L mNSCLC Regimens Driven by Promotional Activities Promotion plays a major role in the successful launch of a new pharmaceutical product. Companies must develop a marketing strategy that effectively communicates the benefits of the therapy and differentiates it from competitors.

Pharmaceutical products 40

Pharmaceutical products Marketing Patients Manufacturing 40

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

Healthcare 40

Healthcare Healthcare Marketing Pharma 40

Contrarian Sales Techniques

FEBRUARY 25, 2023

The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) regulates and ensures the safety, efficacy, and quality of pharmaceutical products on the market.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 75

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 75

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Retail 40

Retail Distribution Pharmaceutical Pharmaceutical products 40

European Pharmaceutical Review

JANUARY 9, 2024

Adding these developments with the addition of connected IoT devices, supply chain restructuring and consideration for our code of ethics will give us a glimpse at how pharmaceutical production will look in future. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

PM360

DECEMBER 20, 2023

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. Regulatory body – NMPA : all pharmaceutical products sold in the Chinese market need to be granted market authorization by NMPA.

Marketing 105

Marketing Insurance Medical Manufacturing 105

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. How can these issues be addressed?

Pharmaceutical 93

Pharmaceutical Food and Drug Administration Transportation Manufacturing 93

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. JSB : When working with regulatory bodies in the life science industry, data integrity is of utmost importance.

Government 87

Government Pharma Ethics Training 87

pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days. Between 2012 and 2020, it averaged 3% each year, whereas Spain’s share, for example, had increased from 2.6%

Government 93

Government Recruitment Medicine Competition 93

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Following QbD to guarantee a drug product's safety. For biosimilars, however, this process is slightly more complex.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical products 52

Rep-Lite

MARCH 14, 2024

Even the knowledge of healthcare economics helps communicate the value proposition of their products in the context of cost-effectiveness and improved patient outcomes. Pharmaceutical Knowledge Thorough pharmaceutical product knowledge in pharmaceutical sales includes therapeutic indications, dosing, and side effects.

Medical sales reps 52

Medical sales reps Medical sales Medical Sales 52

Pharmaceutical Technology

MARCH 22, 2023

The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma FDA 105

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.

Pharmaceutical 126

Pharmaceutical Food and Drug Administration Manufacturing FDA 126

European Pharmaceutical Review

AUGUST 9, 2022

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

Food and Drug Administration 82

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 82

European Pharmaceutical Review

DECEMBER 27, 2023

Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. Approved cellular and gene therapy products [Internet]. FDA; 2022 [cited 2023 Mar]. 2021;3(S1):6–10. Center for Biologics Evaluation and Research.

Manufacturing 82

Manufacturing Food and Drug Administration Patients Pharma 82

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Many test methods have thus been developed.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

Cadensee

JULY 20, 2021

So, you see on one side, there's a special body of the FDA trying to listen to patients to find new targets for health and for pharmaceutical technology. But there's a lot of other things that bother patients and might be a target for healthcare technology, or pharmaceutical products. I've been preaching for that.

Food and Drug Administration 52

Food and Drug Administration Doctors Healthcare Healthcare 52

Pharmaceutical Technology

APRIL 26, 2023

The choice of the primary packaging material for pharmaceuticals is influenced by factors such as the product’s physicochemical properties, stability, route of administration, and regulatory requirements.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52

Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive steps to ease the pharmaceutical’s industry transition to these advanced processes, states the announcement.

Manufacturing 84

Manufacturing Pharma FDA Pharmaceutical products 84