Fierce Pharma

AUGUST 22, 2023

Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, f | Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency to put the kibosh on manufacturing (..)

Manufacturing 189

Manufacturing Medicine Management 189

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. In this Q&A, EPR caught up with CEO James Short and Managing Director Arthur Wakeley from Celadon, to learn more about the company’s experience moving through, and progressing, the strict regulatory process for medicinal cannabis.

Medicine 132

Medicine Manufacturing Specialization Pharmaceutical 132

European Pharmaceutical Review

FEBRUARY 2, 2023

While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients.

Medicine 111

Medicine Manufacturing Pharmaceutical Specialization 111

Fierce Pharma

JUNE 6, 2024

Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey. Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana.

Manufacturing 178

Manufacturing Medicine Leads 178

European Pharmaceutical Review

MARCH 27, 2025

A new industry survey from the Biotechnology Innovation Organization (BIO) highlights the vulnerability of supply that proposed tariffs would put on medicines, and its impact on patient access. This makes supply of medicines vulnerable especially to proposed tariffs on the EU, China, and Canada, according to BIO.

Medicine 52

Medicine Food and Drug Administration Manufacturing Food 52

pharmaphorum

JANUARY 24, 2023

Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. Over the same period, similar countries – including Ireland, France, and Germany – have been moving to boosting manufacturing productivity, output, and exports.

Manufacturing 111

Manufacturing Medicine Government Pharmaceutical manufacturing 111

pharmaphorum

OCTOBER 14, 2024

Damage to a Baxter manufacturing facility caused by Hurricane Helene, which rolled across the east US a couple of weeks ago, has led to shortages in some critical medicines.The plant in North Cove, North Carolina, was severely affected by flooding and had to be shut down at the end of September.

Medicine 115

Medicine Manufacturing Marketing 115

MedCity News

APRIL 25, 2023

Traditionally, pharmaceutical companies have been slow to adopt these newer technologies, instead relying on well-established and proven – but usually complex – manufacturing processes. However, the time to begin investing in – and exploring – AI, machine learning, and big data is now.

Medicine 261

Medicine Manufacturing Pharmaceutical Biopharma 261

Fierce Pharma

OCTOBER 10, 2023

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies.

Prospecting 265

Prospecting Manufacturing Medicine Leads 265

Fierce Pharma

APRIL 23, 2024

grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines. . | As doctors and patients in the U.S.

Doctors 258

Doctors Manufacturing Medicine Patients 258

European Pharmaceutical Review

JANUARY 29, 2024

According to Medicines for Europe, the Munich District Court’s Supplementary Protection Certificate (SPC) manufacturing waiver , issued in Germany in October 2023, is “in conflict” with the objectives of the waiver. ” This threatens investments in manufacturing, according to Medicines for Europe.

Medicine 98

Medicine Manufacturing Competition Marketing 98

European Pharmaceutical Review

MARCH 31, 2023

The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP).

Medicine 105

Medicine Manufacturing Food and Drug Administration Food 105

European Pharmaceutical Review

SEPTEMBER 5, 2023

million to establish a Medicines Manufacturing Skills Centre of Excellence. Enhancing talent in pharmaceutical manufacturing “Talent and skills are fundamental to successful innovation and industry growth. The UK government is investing £5.5

Medicine 98

Medicine Manufacturing Biopharma Pharmaceutical manufacturing 98

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

NOVEMBER 12, 2024

To boost AstraZeneca’s research and manufacturing footprint by the end of 2026, it is dedicating $3.5 AstraZeneca’s investment in manufacturing In August, AstraZeneca announced its single biggest investment in its Sweden Biomanufacturing Center in Södertälje, since the facility opened in 2021. The post New $3.5b

Manufacturing 59

Manufacturing Biopharma Healthcare Healthcare 59

European Pharmaceutical Review

FEBRUARY 13, 2025

Based on the new cost estimates, pharmaceutical manufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.

Medicine 59

Medicine Pharmaceutical manufacturing Manufacturing Competition 59

European Pharmaceutical Review

JUNE 17, 2024

Johnson & Johnson Innovative Medicine is planning to invest a total of €580 million in Italy over the next five years. Lopez told EPR that J&J “are building capabilities for the future by investing in technology and in our workforce to ensure we remain resilient to reliably and efficiently supply our innovative medicines”.

Medicine 97

Medicine Manufacturing Management Government 97

Fierce Pharma

NOVEMBER 28, 2023

Among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages. . | Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to bolster production networks across industries.

Manufacturing 218

Manufacturing Networking Medicine 218

Fierce Pharma

AUGUST 6, 2024

The reorg comes with cost cuts across the medicine's R&D, manufacturing and commercialization support functions. After previously floating the possibility of div | After previously floating the possibility of divesting Roctavian, BioMarin has decided to keep the hemophilia A gene therapy—but with a narrowed focus.

Marketing 239

Marketing Manufacturing Medicine 239

Fierce Pharma

JULY 5, 2023

. | In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to research, develop and manufacture mRNA medicines in China.

Manufacturing 251

Manufacturing Medicine Pharmaceutical 251

European Pharmaceutical Review

JANUARY 18, 2023

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. The firm’s medicinal cannabis product will be supplied in oil form as an API.

Manufacturing 119

Manufacturing Medical Medicine Pharmaceutical 119

European Pharmaceutical Review

NOVEMBER 2, 2023

While unsolicited and burdensome, medicine shortages are an obstacle faced by the pharmaceutical industry. In 2023, a combination of factors, including increased demand (particularly for critical medicines), economic inflation, as well as international geopolitical unrest, has led to Europe’s supply chain being acutely affected.

Medicine 115

Medicine Manufacturing Pharmaceutical Safety 115

Fierce Pharma

SEPTEMBER 9, 2024

With the expiration of a contract to produce antibiotic medicines for Sandoz, GSK will shutter a 75-year-old manufacturing facility in its home country. With the expiration of a contract to produce antibiotic medicines for Sandoz, GSK will shutter a 75-year-old manufacturing facility in its home country.

Manufacturing 184

Manufacturing Medicine 184

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.

Pharmaceutical manufacturing 52

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 52

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

NOVEMBER 23, 2022

The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU).

Medicine 111

Medicine Networking Manufacturing Training 111

European Pharmaceutical Review

SEPTEMBER 12, 2024

billion in two manufacturing sites in Ireland , boosting its medicine production worldwide. Edgardo Hernandez , Executive Vice President and President of Lilly Manufacturing Operations, explained that the company ’s new investments will enhance production of medicines for diabetes, obesity and Alzheimer’s.

Manufacturing 105

Manufacturing Medicine Engineering Pharmaceutical 105

European Pharmaceutical Review

MAY 27, 2024

billion investment for Eli Lilly and Company ’s manufacturing site in Lebanon, Indiana, US, increases the firm’s total investment there from $3.7 This expansion will expand manufacturing capacity of active pharmaceutical ingredients (APIs) for Zepbound ® (tirzepatide) injection and Mounjaro ® (tirzepatide) injection. This new $5.3

Manufacturing 105

Manufacturing Medicine Engineering Pharmaceutical 105

Fierce Pharma

MARCH 14, 2024

After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy (..)

Manufacturing 195

Manufacturing Medicine Patients 195

Pharmaceutical Technology

OCTOBER 28, 2024

China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western countries.

Medicine 95

Medicine Manufacturing 95

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

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

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

pharmaphorum

MARCH 15, 2024

Consortium led by Birmingham University unveils a centre of excellence for medicines manufacturing training using VR, to answer a UK skills shortage.

Training 114

Training Medicine Manufacturing 114

PharmaTimes

OCTOBER 17, 2024

The two-year programme will use virtual reality technology to teach essential skills

Medicine 109

Medicine Manufacturing 109

European Pharmaceutical Review

APRIL 26, 2024

The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination. The post Benefits of 3D printing for personalised medicine formulation appeared first on European Pharmaceutical Review. Rodríguez-Pombo et al.

Medicine 110

Medicine Pharmaceutical Pharmaceutical products Medical 110