Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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Manufacturing Production Contract Manufacturing Contamination 40

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. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

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Manufacturing Production Drugs FDA Compliance 59

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Packaging Packaging Containment Production 98

Pharmaceutical Technology

OCTOBER 26, 2022

Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 According to GlobalData’s Nanopharmaceuticals Thematic Research report, the vast majority of marketed and pipeline nanopharmaceuticals are being used to treat a wide range of cancer indications, highlighting the ongoing unmet needs in this area.

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Jardiance brought in $2.06

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Sales Insulin FDA Approval Drugs 52

Roots Analysis

APRIL 19, 2022

Upstream processing primarily involves the use of single-use bioreactors, sensors, filters, media bags and containers, while in downstream processes, single-use technology is used for chromatography, centrifugation, filtration, sampling system and connectors. [1] 1] The history of bioprocessing technology is mentioned below.

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Marketing Contamination Containment Manufacturing 52

FDA Law Blog

NOVEMBER 22, 2022

coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S.

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The Pharma Data

DECEMBER 28, 2020

(NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. Food and Drug Administration (FDA) for MydCombi , a unique fixed combination mydriatic (pupil dilation) agent.

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Drugs Production Marketing Contamination 52

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Aciclovir (acyclovir) is an antiviral drug, which stops the production (replication) of the virus at the site of infection. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir.

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Pharmacy Containment Sales Licensing 98

XTalks

JANUARY 25, 2023

Abbott, the maker of Similac and other popular baby formula brands, was forced to recall several powdered infant formulas and stop production after the US Food and Drug Administration (FDA) found evidence of unsanitary conditions. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? Will Abbott Ever Recover?

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Bacteria Contamination Production Regulation 52

Roots Analysis

SEPTEMBER 20, 2023

Considering the vast potential of cellular therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapy has garnered considerable attention of players engaged in the healthcare industry, in the past few years.

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Manufacturing Production Contamination Gene Therapy 40

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These allow precise and consistent delivery of a fixed dosage.

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Drug Delivery Containment Contamination Production 40

Roots Analysis

SEPTEMBER 29, 2023

A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation. A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation.

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Contamination Containment Biobanking Packaging 40

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.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. This phase-out comes after an FDA post-market scientific review and analysis from studies found bio-persistence of the grease-proofing substances.

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Packaging Packaging Contamination Containment 98

Druggist

OCTOBER 4, 2020

Drug treatment can be used alongside lifestyle measures. Most of the drugs which are recommended in the symptomatic management of IBS can be purchased over the counter from pharmacies, supermarkets and online. IBS – drug therapy IBS medications are used for symptomatic management of the condition. Drugs to stop diarrhoea.

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Containment Pharmacy Bacteria Sales 98

Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Exactly three decades later, the first CAR T cell therapy hit the market. Training T cells to target tumours. The challenge of manufacturing CAR T cells.

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Manufacturing Gene Genome Genomics 98

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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Drug Delivery Contamination Drugs Production 40

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

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Production Gene Protein Vaccination 52

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Generic Drugs Manufacturing Regulation Drugs 68

Roots Analysis

FEBRUARY 1, 2024

It is worth highlighting, in 2021, TempAid, a cold chain industry offering temperature controlled packaging products, announced the introduction of the first biodegradable shipping container. These containers are available in a single use, as well as reusable format.

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Packaging Packaging Containment Production 40

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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Drugs Packaging Packaging Contamination 130

Drug Discovery World

JANUARY 19, 2023

The market for cell and gene therapies has grown rapidly over the last few years and will likely continue, with forecasts predicting it will grow 39% to around $42.56 coli cell bank that contains the plasmid. coli residual contaminants as well as product-related impurities. billion by 2030 (BioSpace, 11 August 2022).

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DNA Manufacturing Gene Therapy Gene 52

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Exosomes are extracellular vesicles that contain molecular cargoes (such as various proteins, RNAs and DNAs) specific to the origin cell.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Transmission of the molluscum contagiosum virus occurs through direct person-to-person contact or via contaminated objects known as fomites. How Does Ycanth Work?

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FDA Approval Dermatology Trials Clinical Trials 98

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. drug development initiative from 2012 to February 2019. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Before that, Ms. Forward-Looking Statements.

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Clinical Trials Clinical Trials Production Trials 40

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

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Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. 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.

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Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

DECEMBER 8, 2022

The chemical synthesis process enables various chemical modifications to be made in order to enhance the activity of the drug produced. This can be a significant advantage when tackling issues such as drug resistance because analogues of existing drugs can provide new ways to attack drug-resistant pathogens. Free Webinar.

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Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. KB: Some formulations contain low concentrations of the active ingredient. Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility. Free eBook.

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Production Contamination Development Manufacturing 130

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Contamination Manufacturing Containment Production 130

Pharmaceutical Technology

APRIL 16, 2023

Autoinjectors have revolutionised the convenient delivery of low-volume parenteral drugs. But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible.

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Protein Containment Drug Delivery Drugs 130

FDA Law Blog

DECEMBER 14, 2023

The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).

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Regulation Production Contamination Drugs 59

Pharmaceutical Technology

JUNE 14, 2023

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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Containment Manufacturing Contract Manufacturing Bioavailability 130

FDA Law Blog

FEBRUARY 21, 2023

She also announced denial of three citizen petitions asking FDA to conduct rulemaking to allow CBD products marketed as dietary supplements. The statement explains that risk management tools could include clear labeling, prevention of contaminants, CBD content limits, and age restrictions to mitigate the risk of ingestion by children.

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Containment Production Contamination Regulation 40

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Drugs and Vaccines. billion in June.

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Vaccination Vaccine Antibody Life Science 92