European Pharmaceutical Review

AUGUST 31, 2023

[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.

Manufacturing 97

Manufacturing Medicine Management Pharmaceutical 97

European Pharmaceutical Review

AUGUST 30, 2023

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products.

Medicine 105

Medicine Marketing Government Safety 105

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

AUGUST 17, 2023

The National Institutes of Health (NIH) has chosen contract development, and manufacturing organisation (CDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19. MHRA authorises new COVID-19 vaccine What will the intranasal vaccine manufacturing project involve?

Manufacturing 98

Manufacturing Medicine Physicians Safety 98

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 98

Manufacturing Medicine Biopharma Engineering 98

PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. This can result in shareholders’ resentment, negatively impacting the valuation of the manufacturing company.

Medicine 98

Medicine Marketing Pharma Manufacturing 98

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

APRIL 4, 2025

Analytical testing is an essential part of guaranteeing the quality, safety and effectiveness of pharmaceutical products. During the manufacturing processes, pharmaceutical products must be made correctly every time, due to the high level of regulatory oversight.

Pharmaceutical products 64

Pharmaceutical products Manufacturing Pharmaceutical Safety 64

European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. London: European Medicines Agency; 2016 [cited May 2022].

Ethics 98

Ethics Safety Manufacturing Medicine 98

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

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

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

MARCH 27, 2024

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

Safety 94

Safety Marketing Food and Drug Administration Pharmaceutical 94

European Pharmaceutical Review

JUNE 22, 2023

On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety.

Manufacturing 97

Manufacturing Transportation Management Healthcare 97

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

Pharma Pathway

FEBRUARY 11, 2023

Cipla Limited – Walk-In Drive for Production-Formulations/ API/ Sterile Manufacturing/ Quality On 12th Feb’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India.

Manufacturing 88

Manufacturing Safety Pharma Medicine 88

Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. Securing the supply chain.

Medicine 98

Medicine Transportation Manufacturing Biopharma 98

Infuse Medical

FEBRUARY 4, 2025

Inadequate training can result in increased procedural errors, slower adoption of new technologies, and compromised patient safety. For example, a medical device manufacturer seeking to train clinicians worldwide faces logistical hurdles in ensuring uniformity in their training programs.

Training 130

Training Medical Healthcare Healthcare 130

European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The aim is to remove the regulatory burden of reassessment following certain changes and updates to a medical device by a manufacturer.

Medical 105

Medical Food and Drug Administration Manufacturing Safety 105

European Pharmaceutical Review

JANUARY 16, 2023

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The FDA already has a MRA in place with the European Union (EU) and one with the UK.

Food and Drug Administration 122

Food and Drug Administration FDA Manufacturing Food 122

European Pharmaceutical Review

FEBRUARY 21, 2025

Only one eye was treated to mitigate any potential safety issues. The therapy, known as rAAV8.hRKp.AIPL1, hRKp.AIPL1, is designed to enable the retinal cells to work better and to survive longer, by replacing the defective gene with healthy copies, according to the researchers.

Manufacturing 52

Manufacturing Medicine Specialization Consulting 52

Pharma Pathway

SEPTEMBER 14, 2022

Walk-In Interviews for Manufacturing On 18th Sept’ 2022. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Department: Manufacturing. Walk-In Interviews for Manufacturing On 18th Sept’ 2022. Reddy’s Laboratories Ltd.-Walk-In

Manufacturing 77

Manufacturing Engineering Pharmaceutical Safety 77

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

SEPTEMBER 14, 2023

This includes its Macclesfield campus, the UK’s largest pharma manufacturing site. The pharmaceutical firm is investing greatly in its existing infrastructure to facilitate the shift to renewable gas and support a transition to 100 percent renewable energy. This increases renewable energy capacity to the national gas grid.

Manufacturing 111

Manufacturing Medicine Pharmaceutical manufacturing Pharma 111

European Pharmaceutical Review

JULY 19, 2023

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency have published recommendations for avoiding antibiotic shortages in the autumn/winter 2023-2024 season. These suggested actions have been developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

Medicine 98

Medicine Manufacturing Safety Pharmaceutical 98

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

JANUARY 6, 2025

Under the agreement, Roche gains the rights to develop, manufacture and commercialise the ADC IBI3009. The ADC offers encouraging anti-tumour activity in multiple tumour-bearing mouse models, particularly in chemo-resistant tumour types, and has demonstrated a favourable safety profile, the company continued.

Safety 52

Safety Manufacturing Medicine Sales 52

European Pharmaceutical Review

AUGUST 23, 2024

EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1 EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1

Manufacturing 72

Manufacturing Medicine Safety Pharmaceutical 72

European Pharmaceutical Review

JANUARY 23, 2023

The European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , are closely monitoring and responding to current antibiotic shortages in the EU.

Medicine 98

Medicine Manufacturing Safety Patients 98

European Pharmaceutical Review

JULY 25, 2022

As the world now looks to a post-pandemic future, despite the counterfeit medicine trade showing no signs of slowing, industry bodies must come together to tackle the production and trade of fake products. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.

Pharmaceutical 104

Pharmaceutical Medicine Manufacturing Pharmaceutical manufacturing 104

European Pharmaceutical Review

AUGUST 22, 2024

1 Clinical data demonstrating long-term advantage of GLP-1R medicines Recent data shared about tirzepatide (Zepbound® and Mounjaro) by Eli Lilly and Company revealed the promise of these drugs as long-term treatments for obesity and pre-diabetes. The treatment was also shown to hold a “good safety and tolerability” profile.

Medicine 59

Medicine Marketing Manufacturing Sales 59

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. Manufacture and development of Ximluci ®. “We A biosimilar for biologic ophthalmic treatments.

Manufacturing 104

Manufacturing Marketing Medicine Leads 104

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 114

Safety Side effects Patients Medicine 114

European Pharmaceutical Review

FEBRUARY 24, 2023

#atccnews [link] pic.twitter.com/LF38xxYvWM — ATCC (@officialatcc) February 23, 2023 The solutions the organisations will launch together include: Genomic DNA from top cell lines used in bioproduction Measurement of cellular DNA left over following purification is required by regulatory authorities to ensure product safety.

Safety 96

Safety Manufacturing Medicine Management 96