Drug Discovery World

MAY 8, 2024

This webinar will detail how Oxford Nanopore evaluated long-read nanopore sequencing as a comprehensive and sensitive QC method for rAAVs which is supporting internal research activities at AstraZeneca. appeared first on Drug Discovery World (DDW). The post How can long-read nanopore sequencing support gene therapy delivery?

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Gene Therapy Gene DNA Genome 69

Drug Discovery World

MARCH 21, 2023

In a step forward for genetic engineering and synthetic biology, US researchers have modified E coli bacteria to be immune to infection by all natural viruses tested so far. Currently, viruses that infect vats of bacteria can halt production, compromise drug safety, and cost millions of dollars. “We

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Drug Discovery World

APRIL 16, 2024

This webinar will highlight how long-read nanopore sequencing as a comprehensive and sensitive QC method for rAAVs were evaluated — which is supporting internal research activities at AstraZeneca. The post rAAV Genome sequencing uncovers transgene integrity and packaging impurities appeared first on Drug Discovery World (DDW).

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Packaging Packaging Genome Genomics 52

Drug Discovery World

MAY 1, 2024

This webinar will detail how Oxford Nanopore evaluated long-read nanopore sequencing as a comprehensive and sensitive QC method for rAAVs which is supporting internal research activities at AstraZeneca. The post Uncovering packaging impurities with rAAV genome sequencing appeared first on Drug Discovery World (DDW).

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Packaging Packaging Genome Genomics 52

Drug Discovery World

APRIL 24, 2024

This webinar will detail how Oxford Nanopore evaluated long-read nanopore sequencing as a comprehensive and sensitive QC method for rAAVs which is supporting internal research activities at AstraZeneca. The post How rAAV genome sequencing uncovers transgene integrity appeared first on Drug Discovery World (DDW).

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials. Working together, the U.S.

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Druggist

AUGUST 25, 2021

The drug is contaminated with NDMA which is classified by the International Agency on Cancer Research (IARC) as “a probable human carcinogen.” Ranitidine use was associated with a statistically significant 2.4-fold ” The post Does Ranitidine Cause Cancer? appeared first on Druggist.Online.

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Contamination Drugs Research 76

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. ” Then there is a spot for a drug for cancer patients that has a forgettable name. The other issue few people talk about is that the level of talent within the DTC marketing pool has been contaminated.

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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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Drug Discovery World

MAY 22, 2023

In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

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Advarra

JULY 28, 2022

This article explores how these tools work and why biosafety cabinets are preferred in research involving cell and gene therapies. Use of hazardous materials in a clean bench can increase the risk of occupational exposure and contamination of the room in which the work is being done. What is a Biosafety Cabinet?

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Scienmag

DECEMBER 21, 2020

New research suggests that cannabis use by people in care for opioid addiction might improve their treatment outcomes and reduce their risk of being exposed to fentanyl in the contaminated unregulated drug supply.

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Contamination Drugs Research Medicine 40

pharmaphorum

FEBRUARY 15, 2022

The findings point to a “threat to environmental and global health,” say the scientists, who found that paracetamol, antibiotics epilepsy drug carbamazepine, metformin for diabetes and other compounds like caffeine and nicotine were found in samples from around the world – including in Antarctica.

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Drug Discovery World

AUGUST 16, 2022

The drug discovery sector is working to address cancer disparities. Anita Ramanathan examines the importance of inclusivity and diversity throughout the drug discovery and development process. . Here, we highlight the efforts being made to achieve cancer health equity at different stages of drug development. .

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Drug Discovery World

OCTOBER 5, 2022

DDW Editor, Reece Armstrong, sits down with Brinter CEO Tomi Kalpio to learn about the company’s approach to bioprinting and how it can be used throughout drug discovery. . RA: How can bioprinting be used to shorten drug discovery timelines? . This allows researchers to identify the best individual drugs to treat the disease. .

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Drugs Regulation Manufacturing Medicine 52

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus.

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FDA Law Blog

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. That leaves 60% that manufacture at least one application product.

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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs.

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Drug Discovery World

APRIL 25, 2024

Cell line development is an essential underpinning of the drug development process, enabling teams to test, optimise and manufacture therapeutics at a commercial scale. According to Grand View Research, the global cell line development market was valued at $4.81

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The Pharma Data

DECEMBER 17, 2020

drug overdose deaths reached a record high as the coronavirus pandemic held the country in its grip last spring, new government data shows. Ten Western states reported a more than 98% increase in synthetic opioid-involved deaths, the researchers said. THURSDAY, Dec. 17, 2020 — The number of U.S. ” © 2020 HealthDay.

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Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

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Drugs Manufacturing Medicine Compliance 71

XTalks

JUNE 14, 2022

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. While still at an early stage, the researchers hope these nano-sensors could help uncover pesticides before consumption. So, why is it important to detect pesticides on food before consumption?

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Pharmaceutical Technology

JANUARY 12, 2023

Research Associate III, who is a parenteral fill/finish and lyophilization specialist at Baxter BioPharma Solutions (BPS) – a business unit of Baxter Healthcare, Inc. PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material.

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Drug Discovery World

FEBRUARY 8, 2024

AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers. These include automated solutions, proprietary genomics protocols, specialists to advise on global cGMP repository and logistics, plus experts to guide researchers through advanced therapy development.

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Gene Therapy Gene Bioinformatics Life Science 59

pharmaphorum

AUGUST 11, 2022

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. As such, NeoFlex plungers are ideal for highly sensitive, large molecule drugs.

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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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Roots Analysis

SEPTEMBER 29, 2023

Since ice crystals form during simple cooling or freezing, it is impossible to store stem cells and other viable tissues for an extended period of time despite their immense potential for use in basic research and numerous other medical applications. This simple technique streamlines downstream processes and preserves valuable resources.

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XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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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. As our knowledge of the health effects of PFAS evolves, understanding how they get into our bodies and the environment — where they may contaminate crops and water supplies — is critical.

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Packaging Packaging Contamination Containment 98

XTalks

SEPTEMBER 29, 2023

Specialists emphasized the need for more comprehensive research to solidify the evidence concerning its possible toxicity. Nations were prompted to gather data regarding incidence, human prevalence and risk exposure channels to more comprehensively define the threat.

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XTalks

JULY 26, 2021

But several researchers and experts have brought to light some food safety concerns of plant-based meat, and why it must be treated differently than that of animal protein. While it has come along way since its inception, there are a number of factors to consider when it comes to plant-based meat safety, including: Contaminants.

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The Pharma Data

MAY 3, 2021

Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Reviewing nitrosamine contamination. Continuous professional development.

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Pharmacy Checkers

MAY 1, 2020

In late March, drug giant Bayer Pharmaceuticals, out of the goodness of its heart, agreed to donate three million tablets of chloroquine phosphate to help the Trump administration get this drug into U.S. This post isn’t about our constant partisan divide or even Bayer or other evil drug companies, although they are referenced.

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Drugs Pharmacy Manufacturing Production 53

The Pharma Data

DECEMBER 23, 2020

The FDA rapped California-based drug manufacturer Sky Systems in a Form 483 with a dozen observations after an inspection revealed the firm lacked a quality control unit. The investigator found the facility had no procedures in place to conduct annual reviews of products and had missing or incomplete batch production records.

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Pharmaceutical Technology

MAY 17, 2023

Regulatory standards are very tight in order to ensure the safety and efficacy of drugs, so biomanufacturers have to focus on establishing robust processes and using high-quality materials in order to meet these expectations. One big challenge is contamination. Sara Bursomanno (SB): There are many challenges.

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