Contamination, Development and Licensing - Clinical Research Informer

How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

AUGUST 4, 2022

Training and development. Staff development and training programmes were largely on pause during the pandemic. Businesses need to ensure they prioritise the recruitment and development of staff to help ensure longevity and survival. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006.

Development

Development Manufacturing In-Vitro Compliance

DeepVerge’s nanochip-based COVID breath test could be ready this year

pharmaphorum

MARCH 19, 2021

Since the third quarter of last year DeepVerge’s scientists have been working to transform an AI-based water contamination detection system into a unit that tests for the presence of the coronavirus. It has licensed in a patented breathalyser, the analysts noted. A femtogram is 0.000000000000000001 kilograms.

Contamination

Contamination Clinical Trials Clinical Trials Protein

Cyfendus Anthrax Vaccine Wins FDA Approval

XTalks

JULY 25, 2023

Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. What Is Anthrax? Anthrax is a rare, yet severe disease caused by the bacterium B.

FDA Approval

FDA Approval Vaccination Vaccine Antibody

MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

XTalks

JANUARY 4, 2023

“We also thank our partner, BARDA [US Biomedical Advanced Research and Development Authority], for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the US. This US FDA approval of NexoBrid validates our enzymatic technology platform. Clinical Trials of NexoBrid.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Contamination

In the News: July 2021 Regulatory and Development Updates

Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval.

Development

Development Production Regulation Clinical Trials

Advances in cell line development

Drug Discovery World

APRIL 25, 2024

Reece Armstrong offers an overview of cell line development and outlines the benefits the technology is bringing to biopharmaceutical developers. Cell line development is an essential underpinning of the drug development process, enabling teams to test, optimise and manufacture therapeutics at a commercial scale.

Development

Development Protein In-Vivo Life Science

Zovirax Cream for cold sores | Aciclovir (acyclovir) cream

Druggist

SEPTEMBER 15, 2020

Zovirax cream for cold sores is licensed for the treatment of infections caused by Herpes simplex virus presented on lips or face in children and adults. Zovirax over the counter availability Zovirax Cold Sore Cream is licensed as general sale list medications (GSL). What is Zovirax cream? Buy on Amazon Price incl. days versus 4.8

Pharmacy

Pharmacy Containment Sales Licensing

Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. So, we set out to solve some of the problems,” she explains.

Genome

Genome Genomics Medicine Gene Therapy

Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA

pharmaphorum

OCTOBER 7, 2020

The Pharmaceutical Microbiology Conference East Coast Virtual Conference will be commencing on 28th and 29th October 2020 and will focus on technological developments that push innovation and tackle the most pressing challenges in the world of pharmaceutical microbiology.

Contamination

Contamination Production Manufacturing Compliance

Athersys to Host a Virtual Investor Day

The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. 28, 2021 11:00 UTC. About MultiStem ®. About Athersys.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

Athersys Announces Three Appointments to Board of Directors

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. Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

DECEMBER 12, 2019

Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated. The GAO plans to follow up on that to find out why. Why do I write “exact same”?

Drugs

Drugs Manufacturing Medicine Compliance

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 previously $59.4

Vaccination

Vaccination Vaccine Production Sales

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

XTalks

MAY 20, 2022

She said it is also spread through open sores, contact with bodily fluids or by touching contaminated clothes or bedding. In the US, JYNNEOS (also known as Imvamune or Imvanex) is a vaccine that is licensed to prevent both monkeypox and smallpox. Treatments. Outbreaks Outside Africa.

Vaccination

Vaccination Vaccine Contamination Licensing

Clinical Research Informer

How can the pharma industry address the gap in talent recruitment and development?

DeepVerge’s nanochip-based COVID breath test could be ready this year

Trending Sources

Cyfendus Anthrax Vaccine Wins FDA Approval

MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

In the News: July 2021 Regulatory and Development Updates

Advances in cell line development

Zovirax Cream for cold sores | Aciclovir (acyclovir) cream

Modernizing cell culture processes for the next wave of genomic medicine

Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA

Athersys to Host a Virtual Investor Day

Athersys Announces Three Appointments to Board of Directors

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

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