STAT News

NOVEMBER 3, 2022

The trial is being conducted in the U.S. Plans for a $400 million investment by Eli Lilly in a new manufacturing plant in Limerick, Ireland, have been put on hold following an objection by a local landowner over concerns of flooding of his lands by contaminated water , The Irish Examiner reports.

Vaccine 97

Vaccine Vaccination Drug Delivery Systems Sales 97

XTalks

OCTOBER 26, 2020

While some newer plastics are made from recycled food or plant materials, most are made from petroleum and contain polymers and other additives. Manufacturing packaging often pollutes the air with greenhouse gases, heavy metals and particulates and produces wastewater that contains potentially toxic contaminants.

Packaging 98

Packaging Packaging Marketing Containment 98

Pharmaceutical Technology

MAY 11, 2008

In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis. The trial allowed end-to-end traceability of haemophilia medication, which promoted secure deliveries, stock optimisation and greater patient safety.

Drugs 100

Drugs Packaging Packaging Production 100

XTalks

AUGUST 7, 2023

He also thanked the 500 patients, caregivers, investigators and healthcare professionals involved in the Phase III trials and stated that Verrica’s commercial team is actively preparing for the product’s commercial launch in September 2023. Participants in these trials ranged in age from two to 60, with a median age of six.

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

MARCH 10, 2022

Mined talc is prone to asbestos contamination because the two minerals are often found together in nature. The unsealed asbestos experiment files were unearthed in two trials last year pertaining to the baby powder. Johnson & Johnson discontinued selling the baby powder in the US and Canada in May 2020 citing a drop in demand.

Containment 98

Containment Dermatology Contamination Sales 98

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. delivery Sale Zovirax Cold Sore Treatment Cream, Tube 2 g Zovirax contains aciclovir, an anti-viral treatment; always read the label Fights the cold sore virus Works at the tingle and blister £6.19 −£1.60 £4.59 What is Zovirax cream?

Containment 98

Containment Pharmacy Sales Drugs 98

JAMA Internal Medicine

MARCH 7, 2021

-3 fatty acids eicosapentaenoic acid (20:5n-3) and docosahexaenoic acid (22:6n-3) and also contain other nutrients, such as vitamin D, riboflavin, iodine, calcium, phosphorus, magnesium, potassium, zinc, and iron.

Contamination 45

Contamination Clinical Trials Clinical Trials Containment 45

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments. Plastic accounts for 20 to 25 percent of total waste generated by healthcare facilities.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Sciensano

MARCH 27, 2024

Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021.

Contamination 52

Contamination Bacteria Packaging Packaging 52

The Pharma Data

DECEMBER 30, 2020

Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Adding to the list of sketchy hand sanitizers and mouthwashes, a hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, CBS News reported Tuesday. Shane Erickson Inc.

Contamination 52

Contamination Vaccine Vaccination Pharmacy 52

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

The Pharma Data

JANUARY 27, 2021

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

Engineer 52

Engineer Genetics Clinical Research Research 52

Roots Analysis

SEPTEMBER 18, 2023

Due to the infrastructure available for processing, freezing and storing of these container systems, blood bags are the preferred container for cell therapy biopreservation. The above figure presents a general overview of the cryopreservation process.

Engineer 52

Engineer Containment In-Vivo Production 52

The Pharma Data

DECEMBER 28, 2020

With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-Looking Statements.

Drugs 52

Drugs Production Marketing Contamination 52

The Pharma Data

NOVEMBER 15, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

Cloudbyz

AUGUST 19, 2024

Incident Response: Establishing a plan for responding to cybersecurity incidents, including detection, containment, eradication, and recovery. Facility Controls: Ensuring that manufacturing facilities are designed, maintained, and operated to prevent contamination, errors, and defects.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were investigated in various clinical trials. for a pack of three pens, each containing 1.5

Sales 52

Sales Insulin FDA Approval Drugs 52

The Pharma Data

MAY 4, 2021

Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. In March 2021, Pfizer and BioNTech announced topline results from a pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection.

Vaccination 40

Vaccination Vaccine Production Sales 40

XTalks

OCTOBER 16, 2020

However, that outbreak was controlled before Regeneron’s drug could be tested in a clinical trial. A second Ebola outbreak occurred in August 2018 in the Democratic Republic of Congo (DRC), during which evaluation of Inmazeb was initiated in a large-scale clinical trial. The PALM Trial. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

Pharmaceutical Technology

APRIL 12, 2023

The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.

Manufacturing 130

Manufacturing Production Containment Contamination 130

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Novavax has also tested its recombinant SARS-CoV-2 nanoparticle adjuvanted vaccine in a Phase I/II trial.

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Vaccination Vaccine Antibody Life Science 92