European Pharmaceutical Review

FEBRUARY 27, 2024

It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen.

Manufacturing 99

Manufacturing Food and Drug Administration Food Networking 99

Pharmaceutical Commerce

APRIL 10, 2024

If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.

Patients 105

Patients Manufacturing 105

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 81

Manufacturing Medicine Networking Patients 81

European Pharmaceutical Review

FEBRUARY 2, 2024

Orano Med (a subsidiary of the Orano Group), has begun to build a new manufacturing site for targeted alpha therapies (TAT) for oncology indications. So construction of the new radioligand therapy manufacturing site in France is a major step towards making these promising new treatments available to cancer patients with high unmet needs.

Manufacturing 85

Manufacturing Distribution Leads Pharmaceutical 85

European Pharmaceutical Review

JANUARY 12, 2024

New technologies at the facility will support the increased manufacturing capacity, the company stated on X. The post Boehringer plans €120m European manufacturing expansion appeared first on European Pharmaceutical Review. The expansion will boost exports of medicines from Greece to the US market.

Manufacturing 94

Manufacturing Medicine Pharmaceutical Pharma 94

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. There is a massive gap in the supply and demand for this innovative technology.

Manufacturing 82

Manufacturing Medicine Government Pharmaceutical 82

Pharmaceutical Commerce

FEBRUARY 9, 2024

Researchers explore the proportion of approved drugs in the Canadian marketplace that utilize manufacturer-sponsored patient support programs, along with the types of medications that are more likely to do so.

Patients 105

Patients Manufacturing Medical 105

European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. The contact is valued at some $411 million, according to a company filing.

Manufacturing 92

Manufacturing Patients Management Pharmaceutical 92

European Pharmaceutical Review

NOVEMBER 10, 2023

Novo Nordisk has announced plans to invest over 42 billion Danish kroner (nearly £5 billion) starting in 2023, to expand its manufacturing facilities in Kalundborg, Denmark. According to the pharma company , the financing will add to global capacity: from manufacturing of active pharmaceutical ingredients (API) through to packaging.

Manufacturing 94

Manufacturing Pharmaceutical manufacturing Pharmaceutical Medicine 94

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 77

Manufacturing Medicine Patients Leads 77

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. The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said. “The

Manufacturing 91

Manufacturing Food and Drug Administration FDA Engineering 91

PharmaTech

DECEMBER 16, 2022

Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care.

Manufacturing 83

Manufacturing Patients 83

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 95

Pharmaceutical manufacturing Manufacturing Pharmaceutical Medicine 95

European Pharmaceutical Review

MAY 16, 2023

Sandoz and Just – Evotec Biologics have announced a partnership to develop and manufacture multiple biosimilars. Within the agreement, Sandoz will gain access to an artificial intelligence (AI) -driven technology platform that delivers fully integrated drug substance development and continuous manufacturing.

Manufacturing 84

Manufacturing Pharmaceutical Patients 84

European Pharmaceutical Review

FEBRUARY 21, 2023

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

Medicine 128

Medicine Manufacturing Specialization Pharmaceutical 128

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. Thus, the MHRA’s approval supports improved regulation of medical cannabis manufacturing.

Manufacturing 106

Manufacturing Medical Medicine Pharmaceutical 106

Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Manufacturing 131

Manufacturing Insurance Pharmaceutical Marketing 131

European Pharmaceutical Review

JUNE 27, 2023

Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US.

Manufacturing 93

Manufacturing Pharmaceutical Patients 93

European Pharmaceutical Review

NOVEMBER 20, 2023

billion parenteral (injectable) manufacturing site in Alzey, Rhineland-Palatinate, Germany. This includes automation and high-speed manufacturing lines. With the planned additional manufacturing facility in Alzey, the company will operate a total of six manufacturing sites in Europe.

Manufacturing 83

Manufacturing Medicine Biopharma Engineering 83

European Pharmaceutical Review

DECEMBER 4, 2023

To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.

Pharmaceutical manufacturing 89

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 89

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. This is important due to the UK’s currently limited short-scale manufacturing capacity.

Manufacturing 105

Manufacturing Distribution Medicine Patients 105

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 86

Manufacturing Medicine Consulting Engineering 86

European Pharmaceutical Review

MAY 1, 2023

After agreeing to acquire a US-based manufacturing facility and its operations from Novartis, Bristol Myers Squibb (BMS) adds in-house production of viral vectors to its capabilities. This move will support the expansion of the company’s global cell therapy manufacturing network.

Manufacturing 80

Manufacturing Engineering Networking Patients 80

Fierce Pharma

APRIL 10, 2024

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)

Recruitment 238

Recruitment FDA Manufacturing Patients 238

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 227

Manufacturing Medicine Patients 227

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 85

Manufacturing Medicine Pharmaceutical Pharma 85

European Pharmaceutical Review

DECEMBER 21, 2022

AstraZeneca has announced it is expanding its current partnership with AI-based company G42 Healthcare, by signing an agreement to manufacture innovative drugs in Abu Dhabi, aligning with Abu Dhabi’s Industrial Strategy to double the size of its manufacturing sector by 2031. Manufacturing drugs in Abu Dhabi.

Manufacturing 83

Manufacturing Pharmaceutical Healthcare Healthcare 83

Pharmaceutical Technology

MARCH 6, 2024

To protect patient safety and reduce recall risks, drug manufacturers must reduce particle contamination sources wherever possible.

Manufacturing 52

Manufacturing Safety Patients 52

European Pharmaceutical Review

DECEMBER 23, 2022

With over 90,000 employees across the globe, Sanofi supplies over 5 billion doses of medicines and vaccines every year, supporting the health needs of millions of patients in more than 170 countries. Standardise manufacturing . Digitalise manufacturing: artificial intelligence and machine learning.

Manufacturing 82

Manufacturing Networking Medicine Electronics 82

MedCity News

APRIL 10, 2023

Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.

Manufacturing 95

Manufacturing Medical Healthcare Provider Safety 95

European Pharmaceutical Review

DECEMBER 2, 2022

billion in its manufacturing site in Grange Castle , Dublin, the company’s biggest expansion investment to date in Ireland. A new facility will be built on the site premises, doubling the capacity for biologics manufacturing at the facility. The firm’s manufacturing sites in Grange Castle, Newbridge, Co. Pfizer Inc.

Manufacturing 93

Manufacturing Medicine Networking Medical 93

Pharmaceutical Commerce

APRIL 2, 2024

Why manufacturers should leverage technology to address low adherence rates.

Patients 110

Patients Manufacturing 110

European Pharmaceutical Review

APRIL 27, 2023

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.

Manufacturing 77

Manufacturing Food and Drug Administration Pharmaceutical products Food 77

World of DTC Marketing

MARCH 23, 2022

Do patients care? Do patients care? If you’re a cancer patient and your oncologist is prescribing a drug approved via accelerated Approval, are you going to refuse treatment? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”? Of course not.

Patients 200

Patients FDA Doctors Physicians 200

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

Manufacturing 111

Manufacturing Pharma Biopharma Management 111

European Pharmaceutical Review

JUNE 15, 2023

This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures. Importantly, they identify potential sources of microbial contamination and assess their risk to patients. Medical devices are essential tools for diagnosing, monitoring and treating a variety of conditions.

Manufacturing 79

Manufacturing Medical Safety Transportation 79

Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK.

Manufacturing 105

Manufacturing Government Medicine Healthcare 105