European Pharmaceutical Review

OCTOBER 22, 2024

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.

Medicine 89

Medicine Manufacturing Safety Consulting 89

European Pharmaceutical Review

MAY 2, 2024

In this Q&A, Sigma elucidated on the current key trends and challenges within field, with two major obstacles being the “translatability of the preclinical data to the human patient and the manufacturability of the drugs being developed” How has the development landscape for biologics evolved over the last several years?

Medicine 105

Medicine Manufacturing Biopharma Engineering 105

European Pharmaceutical Review

APRIL 10, 2025

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 52

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

Manufacturing 105

Manufacturing Medicine Consulting Engineering 105

European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

NOVEMBER 23, 2023

Following the UK government’s recent announcement of a £520 million funding boost for UK manufacturing, a new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland will develop innovative and sustainable techniques for these medicines. This is a first-of-its-kind collaboration for the pharma industry.

Manufacturing 104

Manufacturing Medicine Government Pharmaceutical 104

European Pharmaceutical Review

SEPTEMBER 28, 2023

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

Pharmaceutical manufacturing 105

Pharmaceutical manufacturing Manufacturing Pharmaceutical Medicine 105

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Medicine 98

Medicine Distribution Manufacturing Management 98

MedCity News

JULY 27, 2023

However, one-size-fits-all solutions have disadvantages in medicine today. Current applications Today, there is an escalated appetite to address emerging procedures because they offer an opportunity for device makers – and physicians like me who are interested in cutting-edge technology – to influence new areas of medicine.

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Specialization Medical Medicine Leads 241

European Pharmaceutical Review

MARCH 1, 2023

million collaboration between the Centre for Process Innovation (CPI), AstraZeneca, Novartis, and The University of Manchester aims to revolutionise oligonucleotide manufacture. The three-year project is planned to translate “…approaches to oligonucleotide synthesis into sustainable manufacturing processes.

Manufacturing 98

Manufacturing Medicine Pharmaceutical Pharma 98

European Pharmaceutical Review

NOVEMBER 30, 2022

The UK-based Centre for Process Innovation (CPI) has opened its £88 million Medicines Manufacturing Innovation Centre in Glasgow, Scotland, to help accelerate medicine development by focusing on small molecule and fine chemical manufacturing and sustainable manufacturing. The facility is part of CPI’s series of ?‘Grand

Manufacturing 98

Manufacturing Government Medicine Pharma 98

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.

Medicine 99

Medicine Specialization Networking Patients 99

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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FDA Insurance Prescription Medicine 234

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. It is located on the company’s existing Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade.

Manufacturing 105

Manufacturing Food and Drug Administration FDA Engineering 105

European Pharmaceutical Review

NOVEMBER 15, 2023

[Sandoz] has the only major remaining vertically-integrated production network for penicillins in Europe” Penicillins are the leading category of antibiotics worldwide, Sandoz highlighted. This represents a significant upgrade of penicillin active pharmaceutical ingredient (API) manufacturing, Sandoz declared.

Medicine 93

Medicine Manufacturing Networking Biopharma 93

European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialisation of exa-cel.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

FEBRUARY 7, 2024

AstraZeneca has announced a $300 million investment in a US-based manufacturing facility in Rockville, Maryland, which will focus initially on T-cell therapies for oncology indications. Currently, AstraZeneca’s manufacturing sites in the US focus on producing small molecules and biologics, the company highlighted.

Manufacturing 103

Manufacturing Medicine Networking Patients 103

European Pharmaceutical Review

NOVEMBER 10, 2022

A new wave of medicines has emerged in recent years to supplement the well-established small and large molecule platforms that have historically dominated the market. Complex medicines offer diverse therapeutic modalities, including RNA therapeutics and antibody-drug conjugates (ADCs). What constitutes a complex medicine?

Medicine 105

Medicine Distribution Engineering Electronics 105

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. How does it do this?

Manufacturing 98

Manufacturing Medicine Leads Patients 98

European Pharmaceutical Review

MAY 10, 2023

Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The investment “strengthens Bavaria’s position as a leading biotechnology hub” and will help to generate “innovation and job growth” noted Bavarian Prime Minister Dr Markus Söder.

Manufacturing 98

Manufacturing Medicine Networking Biopharma 98

European Pharmaceutical Review

SEPTEMBER 11, 2023

The Cell and Gene Therapy Catapult (CGT Catapult) is set to improve the process and efficiency of AAV manufacture for gene therapies as part of a two-year project alongside two other organisations. The new PAT project aims develop an automated gene therapy manufacturing platform.

Manufacturing 97

Manufacturing Biopharma Medicine Leads 97

European Pharmaceutical Review

OCTOBER 11, 2023

As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned.

Manufacturing 97

Manufacturing Medicine Patients Leads 97

Infuse Medical

FEBRUARY 4, 2025

Difficulty in Mastering Complex Procedures The complexity of modern medical devices and procedures often leads to steep learning curves. Consider a newly introduced robotic surgical system: without comprehensive training, even experienced surgeons may struggle to master its nuances, leading to longer procedures and potential complications.

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Training Medical Healthcare Healthcare 130

European Pharmaceutical Review

APRIL 11, 2024

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. megatonnes in the same year, and the increased demand and complexity of medicines since then will only have swollen this figure. 1 That’s more than the automotive sector, which released 46.4

Manufacturing 105

Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 105

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. Personalised medicines will also be developed at the centre.

Manufacturing 105

Manufacturing Medicine Distribution Patients 105

European Pharmaceutical Review

NOVEMBER 30, 2023

o find out about the current trends in cell and gene therapy manufacturing, EPR spoke to Cell and Gene Therapy Catapult (CGT Catapult)’s Chief Manufacturing Officer, Stephen Ward, and Chief Business Officer, Jeanette Evans. Licensing of the manufacturing suites is expected in early 2024. So now we have a really nice blend.”

Manufacturing 97

Manufacturing Recruitment Medicine Biopharma 97

European Pharmaceutical Review

DECEMBER 27, 2023

2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

APRIL 4, 2025

During the manufacturing processes, pharmaceutical products must be made correctly every time, due to the high level of regulatory oversight. The human element plays a significant role in analytical testing for pharmaceuticals, as variability between analysts can lead to inconsistencies.

Pharmaceutical products 64

Pharmaceutical products Manufacturing Pharmaceutical Safety 64

European Pharmaceutical Review

APRIL 15, 2025

New recommendations issued by the EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , aim to address supply chain vulnerabilities for radiopharmaceutical medicines.

Medicine 52

Medicine Transportation Medical Safety 52

World of DTC Marketing

NOVEMBER 18, 2021

group that reviews the value of medicines said on Tuesday. leading to an almost $1.4 spending” The Boston-based Institute for Clinical and Economic Review (ICER) said in a report that after reviewing published studies and input from drug manufacturers it found no evidence of new clinical benefits to justify the price hikes.

Pharma 202

Pharma Medicine Prescription Manufacturing 202

European Pharmaceutical Review

AUGUST 19, 2022

Rising demand for therapeutics, especially in developing markets, is expected to expand the global pharmaceutical contract manufacturing market to $130.2 billion by 2026, as contract manufacturing organisations increasingly adopt newer and efficient ways to package products, increasing demand for new machinery. billion by 2026.

Manufacturing 98

Manufacturing Marketing Pharma Pharmaceutical 98

European Pharmaceutical Review

FEBRUARY 21, 2025

Gene therapy trial facilitates major vision improvement The post First-in-human data for gene therapy signals potential in childhood blindness appeared first on European Pharmaceutical Review.

Manufacturing 52

Manufacturing Medicine Specialization Consulting 52

Medgadget

JUNE 22, 2022

The researchers hope that the technology will lead to a variety of medical robotics, such as self-steering endoscopes or drug delivery robots that can navigate to specific regions in the body. Typically, most small robots (or large robots for that matter) require a series of complex manufacturing steps to assemble various tiny components.

Manufacturing 97

Manufacturing Medical Engineering Leads 97

European Pharmaceutical Review

DECEMBER 3, 2024

Developing a potential first-in-class medicine for Huntington’s disease “This collaboration combines PTC’s expertise in developing small molecule splicing therapies with Novartis’s expertise in global development and commercialisation of neuroscience therapies. A total of up to $1.9

Biopharma 59

Biopharma Leads Pharmaceutical Manufacturing 59

European Pharmaceutical Review

OCTOBER 16, 2024

Three industry partners have agreed to collaborate to develop an intensified perfusion process for manufacturing adeno-associated virus (AAV) vectors, leading to improved gene therapy production. The post AAV gene therapy manufacturing gets £1.4m The two-year project is supported by a £1.4

Manufacturing 64

Manufacturing Medicine Leads Healthcare 64

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Worldwide sourcing and drop-ship of orphan medicines, and. Discover the top pharmaceutical wholesalers. GDP and GMP advisory.

Leads 52

Leads Pharmaceutical Customer Relationship Management Retail 52

European Pharmaceutical Review

OCTOBER 5, 2023

Maja Pedersen has been appointed as Chief Quality Officer (CQO), to lead FUJIFILM Diosynth Biotechnologies’ global quality team. Pedersen’s new role is effective immediately. As a member of the executive leadership team, she will report to President and CEO Lars Petersen, who was appointed in June this year.

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Recruitment Manufacturing Biopharma Leads 105