STAT

OCTOBER 20, 2023

Today, the criteria used to assess the clinical value of new pharmaceuticals and medical devices varies widely across Europe, making it more challenging for biopharma companies to efficiently launch products in multiple countries and contributing to the disparities in access across the continent.

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215

Express Pharma

MAY 7, 2024

The product is used to treat amyotrophic lateral sclerosis (ALS) Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single-Dose Bags. The Company expects to launch this Product through its marketing partner within FY25.

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99

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation establishes that the cleaning procedure can effectively remove product residue from pharmaceutical equipment to an acceptable limit. Equipment that is used for processing medicines is one of the top sources of contamination if not cleaned effectively using a validated cleaning procedure.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

Express Pharma

MAY 7, 2024

Technologies and solutions that facilitate the maximisation of profit are thus under intense scrutiny by pharmaceutical producers, who are particularly focused on production flexibility, robotics implementation and sustainability, especially in terms of recycling and reducing consumption and waste. in the EU).

Packaging 101

Packaging Pharmaceutical Manufacturing Labelling 101

GMPSOP

MARCH 3, 2024

To prevent cross-contamination, pharmaceutical companies implement strict hygiene and sanitation procedures, robust cleaning programs, use dedicated equipment & facilities, and perform regular quality control tests and QA release activities throughout the supply chain.

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

FADIC

MARCH 22, 2024

Causes of Fever A fever may be classified as idiopathic in nature, but it can also be the result of numerous factors, such as an infectious or pathologic process, a vigorous exercise, or a response to the use of certain pharmacological agents, also known as a drug fever. APAP and ibuprofen are the 2 most extensively used antipyretics.

Immunity 103

Immunity Immunization Dosage Packaging 103

GMPSOP

FEBRUARY 15, 2024

All staff in a production and laboratory environment are collectively responsible for maintaining good housekeeping practices. Approval of cleaning compounds The quality assurance manager is responsible for approving cleaning compounds that are safe to use during housekeeping cleaning activities. Who is responsible for housekeeping?

Documentation 52

Documentation Labelling Compounding Packaging 52

Express Pharma

MARCH 14, 2024

New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day Syngene International is set to announce that its newly upgraded biologics facility – Unit 3 – would be operational for clinical and commercial supply in the second half of 2024, at DCAT 2024.

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98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

Documentation 87

Documentation Method Validation Packaging Labelling 87

European Pharmaceutical Review

SEPTEMBER 20, 2023

In recent years, the pharmaceutical industry has undergone a remarkable revolution, ushering in new and innovative products to address a wide range of unmet medical needs. This is the point at which mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development. Where now with quality by design?

Drug Development 81

Drug Development 81

FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

Documentation 115

Documentation 115

Express Pharma

MARCH 19, 2024

Versavo is the first Dr Reddy’s biosimilar product to be approved and launched in the UK. It is available in strengths of 100 mg and 400 mg single use vials. In Colombia, the product was launched under the brand name Persivia. Dr Reddy’s launched Versavo in India in 2019.

Biosimilars 86

Biosimilars 86

PharmaTech

MAY 2, 2024

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

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59

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Dr Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC. Miriam Guest, Principal Microbiologist at AstraZeneca.

Vaccines 126

Vaccines Research Laboratories Documentation Compounding 126

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

Labelling 105

Labelling Data Entry Communication Hospitals 105

Express Pharma

MAY 10, 2023

We are also seeing a shift away from the old ways when patients used to go to pharmacists to pick up the medicines they needed. Today the pharma, healthcare, and retail industries offer not just products, but personalised experiences and value-added services to patients.

Labelling 92

Labelling Vaccines 92

European Pharmaceutical Review

FEBRUARY 12, 2024

But scaling up production and ensuring global supply of sensitive biological pharmaceuticals is a remarkable process that embodies Industry 4.0 – the rapid technological advancement that is characterising the fourth industrial revolution – and the very latest in advanced manufacturing technologies.

Process Improvement 88

Process Improvement Packaging 88

Pharma Marketing Network

OCTOBER 13, 2023

Multichannel marketing is an effective digital strategy for pharmaceutical companies to reach consumers and encourage them to purchase products. Defining Multichannel Marketing Multichannel marketing is the practice of using multiple channels to communicate with customers and promote products or services.

Communication 98

Communication Pharmaceutical Companies Pharmaceutical Companies 98

Quality Matters

MARCH 13, 2024

Yet, most of these deaths could be prevented with better access to simple, widely available maternal health (MH) products. While challenges to access have long existed in sub-Saharan Africa (SSA), supply chain issues for pharmaceutical products were greatly exacerbated during the COVID-19 pandemic.

Packaging 69

Packaging Pharmaceutical Manufacturing Hospitals 69

European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications.

Immunity 83

Immunity Immunization Chemotherapy Diabetes 83

European Pharmaceutical Review

APRIL 24, 2024

Sterile tryptone soya agar 55mm diameter tryptone soya agar RODAC contact plates were used in the investigation. stated that they aimed to determine “a convenient manual sampling procedure that can be routinely used to provide more consistency of practice”. Eaton et al. Eaton et al. However, Eaton et al.

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78

European Pharmaceutical Review

NOVEMBER 24, 2022

The number of unauthorised and unregulated online outlets selling counterfeit pharmaceutical products is continuously growing, with many selling counterfeit medications via the internet typically posing as legitimate vendors. One area in which the problem can be tackled effectively is product packaging.

Packaging 97

Packaging Labelling Documentation Dosage 97

Express Pharma

JULY 6, 2023

No Product Name Batch No Expiry Date 1 Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20045 Nov.2023 The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number – IB20056), where leakage was observed through the inhaler valve.

Packaging 88

Packaging 88

epicur

MAY 6, 2024

But then, I always recommend having a mix of vendors and distributors, hopefully, a mix of smaller and larger ones, so that you might be able to find a product from another partner. But if it’s completely unavailable, start by looking at alternatives, whether compounded or a similar product. What about expired medications?

Customer Service 52

Customer Service Compounding Chemotherapy Online Pharmacies 52

Express Pharma

MAY 14, 2024

The key characteristic of the Alpha Go algorithm is that, instead of only reacting to the information that is provided, it learns the game’s rules, uses tactics that have never been considered by humans, and even finds new rules as it goes. www.science.org/doi/10.1126/science.adf2465).

Drug Development 59

Drug Development Communication Pharmaceutical Companies Pharmaceutical Companies 59

Digital Pharmacist

DECEMBER 20, 2023

By shifting your focus, you can meet your patient base on the devices and platforms they use every day, establish an online presence, and market yourself on multiple channels. For example, this could be cost, convenience, location, or specialty products and services. How Can Pharmacies Attract Customers?

Communication 98

Communication Immunity Immunization 98

Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Increasing product yield is the most fundamental way to achieve this.

Documentation 94

Documentation Communication 94

European Pharmaceutical Review

MAY 8, 2024

Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the approval of the first two commercial donor-derived products, Rebyota and VOWST, in 2022 and 2023, respectively.

Medical Schools 68

Medical Schools Drug Development 68

European Pharmaceutical Review

AUGUST 31, 2023

Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. To cope with the growing demand for production flexibility and agility, IMA Group is structured according to highly specialised pharmaceutical divisions that concentrate on specific processing and packaging areas.

Vaccines 83

Vaccines Packaging Pharmaceutical Companies Pharmaceutical Companies 83

Quality Matters

SEPTEMBER 21, 2023

These advances impact not only TB, but also other diseases, like HIV/AIDS, and improve maternal, newborn, and child health, making health systems stronger across the board, ensuring patients have access to quality-assured medical products.

Health Care Clinics 69

Health Care Clinics Vaccines Hospitals 69

PharmaState Academy

MARCH 7, 2024

Participation by using another name & email id will lead to disqualification. Participation by using another name & email id will lead to disqualification. The Quiz has to be attempted in a single go. Use a strong internet connection for attempting the Quiz. Note: You can participate only 1 time.

Packaging 64

Packaging Drug Development Pharmaceutical Manufacturing 64

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. All but one patient in the trial received a single dose of Caldolor. Cumberland sponsored a multi-centre trial in 21 hospitalised infants in order to validate its expanded usage.

Labelling 98

Labelling 98

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

Drug Pricing 84

Drug Pricing Packaging Vaccines Drug Development 84

Express Pharma

MAY 22, 2023

An eminent panel of pharma experts and leaders came together to explore approaches to build an ecosystem for developing scientifically proven, evidence-based nutraceutical products. This article is a summation of the inferences drawn and lessons learnt from the views, concerns and insights shared by experts on this knowledge-sharing platform.

Dosage 100

Dosage Method Validation Labelling Immunity 100

Express Pharma

OCTOBER 31, 2023

The manufacturing suites will be equipped for intensified processing using single-use bioreactors and advanced downstream purification capability to serve it’s rapidly expanding biologics customer base.

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100

Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. Companies are testing the use of digital platforms along with pharmacological treatments.

Packaging 111

Packaging 111