Drug Discovery World

OCTOBER 3, 2023

Earlier this year, DDW hosted a webinar, ‘A comprehensive guide to using adeno-associated virus (AAV) vectors in gene therapy’, supported by Azenta Life Sciences. Questions were fielded from the audience, which included: What analysis will be performed to evaluate host or other DNA contamination?

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Gene Therapy Gene Life Science Bioinformatics 52

pharmaphorum

FEBRUARY 3, 2022

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. Uncover principles in best-practice and the benefits of a robust contamination control strategy. View the full agenda: [link].

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

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XTalks

JULY 22, 2021

Pfizer is recalling three more lots of its smoking cessation drug Chantix (varenicline) after having issued a voluntary recall of the drug earlier this month due to carcinogen concerns, bringing the total number of affected lots to 12. As a result, there are currently shortages of the drug in the US. mg and 1 mg doses.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. In 2023, Ozempic was the 13 th best-selling drug globally.

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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

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). anthracis exposure.

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Drug Discovery World

MAY 22, 2023

While the global economic landscape faces a major crisis and biotech is not recession-proof, cell and gene therapy (CGT) has continued to progress with acquisitions, breaking ground on new facilities and approvals across the year – not limited to the breakout of the world’s most expensive drug. million per dose.

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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

NOVEMBER 7, 2023

The role of medical science liaisons could also entail a range of other responsibilities, such as: Designing and carrying out studies to explore medical conditions and the prevention or treatment strategies for these conditions. Implementing protocols to ensure safety and prevent contamination in their work environment.

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Roots Analysis

AUGUST 30, 2023

Breakthroughs in the biotechnology industry, over the last few decades, has provided a considerable boost to the overall development landscape of biopharmaceutical drugs. In 2022, a milestone was witnessed when the number of approvals received by biologics narrowly outpaced those reported by small molecules.

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XTalks

AUGUST 3, 2021

Concerns of asbestos contamination in Johnson & Johnson’s talc-based formulations have been around since the 1970s, with the company accused of ignoring and failing to report them to the US Food and Drug Administration (FDA).

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XTalks

FEBRUARY 21, 2022

Called the “BioNTainer,” the container solution will consist of the active drug substance and one formulation module, each called a BioNTainer. He said this is because “we know that mRNA is a new drug class, which is suitable for different types of vaccines.”.

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Advarra

SEPTEMBER 14, 2023

Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) established a set of 10 principles to guide regulation of such AI/ML-developed devices. Working together, the U.S.

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XTalks

MAY 13, 2022

In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. USP <1207.1>:

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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. The market for cell line development is currently rising due to an increased focus by the life sciences sector on biopharmaceuticals and targeted therapies.

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Pharmaceutical Technology

FEBRUARY 3, 2023

As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. Biores Open Access. 2020 Oct 16;9(1):219-228.

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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. Bahassi emphasized that each one of those methods has its own challenges that limit its clinical implementation.

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Drug Discovery World

NOVEMBER 1, 2023

Life sciences companies are set to compete in a Dragon’s Den session at the BIA’s BioProcessUK event this month. Taking place on day two of BIA BioProcess UK, the Dragon’s Den special session is focused on next generation analytical technologies and will see six companies compete for an audience vote. Chairing the session will be Julie Kerby, (..)

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Life Science Contamination Gene Therapy Manufacturing 52

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. The pharmaceutical and life sciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US.

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XTalks

FEBRUARY 26, 2021

Having become a staple in research labs, HeLa cells have been in use for over 60 years, having been used in the development of the first live polio vaccine, drugs for treating herpes, Parkinson’s and leukemia, as well as in AIDS research and determining the long-term effects of radiation.

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Scientist Research Genetics Cosmetics 69

Delveinsight

SEPTEMBER 8, 2021

Especially in the field of Pharmaceutical & Life Sciences, a company’s all-around product life-cycle stages, which consist of planning, designing, constructing, product testing, and commissioning processes are provided by a Pharma Consultant. Pharma Consultant. Pharma Consultancy Modus Operandi.

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Drug Discovery World

AUGUST 10, 2022

For example, one clinical trial examined the safety and efficacy of a CAR T cell that includes a suicide gene, which produces a toxic protein that causes the CAR T cells to die upon exposure to a drug 10. In general, cell therapies represent a new kind of ‘drug’—one that is living, and therefore cannot be fully predicted or controlled.

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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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The Pharma Data

NOVEMBER 15, 2020

She chairs the board of directors of Sellas Life Sciences, a publicly traded biotechnology company, chairs its nominations & governance committee, and is a member of its audit, compensation and finance committees. drug development initiative from 2012 to February 2019.

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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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XTalks

SEPTEMBER 14, 2020

Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. percent in 2021.

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