XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. How personalized, targeted assays can be developed to detect somatic mutations from cfDNA. “A

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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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.

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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.

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XTalks

JANUARY 4, 2023

We appreciate and thank the burn patients who participated in our trials, the clinical investigators and our researchers for their commitment and efforts to attain this significant achievement.”. “We Clinical Trials of NexoBrid. This US FDA approval of NexoBrid validates our enzymatic technology platform.

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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. In short, the entire regulatory history of tacrolimus until now, spanning 25+ years, has been based on prospective clinical trials. Bill Stoltman, JD.

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The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart.

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XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. In March, the US Food and Drug Administration (FDA) updated the definition of “healthy,” which could impact new product development or reformulation.

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Pharmaceutical Technology

JULY 22, 2022

However, the development added to the concerns of increased monkeypox outbreaks in both the US and Canada, while confirmed cases have been reported from both Spain and Portugal, the article highlighted. Peter Hotez’s tweet on PAI Life Sciences’ phase 1 trial of its snail fever vaccine.

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Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. In contrast, most biologics are complex mixtures that are difficult to completely identify or characterize.

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Drug Discovery World

OCTOBER 5, 2022

The company has developed modular technology that can print multi-material and highly complex tissue structures in 3D, providing all the basic features needed for bioprinting. It is made as a one-size-fits-all approach, based on huge trials. Brinter is a provider of 3D bioprinting solutions based in Turku, Finland and the US.

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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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials. Why Does the IBC Need to do a Risk Assessment?

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Find Me Cure

MARCH 13, 2020

Second to respiratory droplets (someone coughing or sneezing less than 6 feet away from you), touching contaminated surfaces is the fastest way to spread the virus. . In fact, there are as many as 16 clinical trials already available on our platform ranging in purpose from observation to prevention to treatment.

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The Pharma Data

AUGUST 21, 2020

As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. We are honored that the US government has asked McKesson to play a key role in the effort to distribute Covid-19 vaccines,” Tyler added.

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The Pharma Data

DECEMBER 28, 2020

MydCombi was developed to address several needs of the eye care practitioner’s office. With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. The NDA submission was based on the MIST-1 and MIST-2 studies. About Eyenovia, Inc.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Trulicity (Dulaglutide) Trulicity sales in 2022: $7.439 billion Company/Developer: Eli Lilly & Co.

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Druggist

SEPTEMBER 15, 2020

Aciclovir cream did not prevent the development of lesions formation (filled with fluid) and the latest stage of crust formation (ibid). Acyclovir cream for the treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials. days versus 4.8 days versus 5.2 doi:10.1128/aac.46.7.2238-2243.2002

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XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., 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.

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The Pharma Data

OCTOBER 30, 2020

In particular, the Committee appreciated WHO’s critical role in developing evidence-based guidance and recommendations; providing countries with technical assistance and operational support; communicating clear information and addressing misinformation; and convening the Solidarity Trials and the Access to COVID-19 Tools (ACT) Accelerator.

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Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs). Particle analysis on a micro-scale is a significant topic in several fields of application.

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Drug Discovery World

AUGUST 10, 2022

And as researchers study all of these factors, they are also discovering that CAR T cell development and manufacturing require a new approach to quality control to ensure their safety and efficacy. Developing the first CAR T cell therapy. These treatments have shown success in treating a variety ofcancers 4.

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XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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STAT News

NOVEMBER 3, 2022

The single-dose vaccine candidate is a combination of Pfizer’s mRNA-based flu shot and the Omicron-tailored Covid-19 booster shot developed by both companies. The trial is being conducted in the U.S. and the companies aim to enroll 180 volunteers between the ages of 18 and 64.

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Drug Discovery World

JANUARY 19, 2023

Plasmid DNA: a critical reagent pDNA is the starting material for the development of many cell and gene therapy products, irrespective of the mode of action. Figure 1 shows the development pathways for non-viral and viral vector gene therapies, and cell therapy and illustrates the critical role pDNA plays in their development.

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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.

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Drug Discovery World

AUGUST 16, 2022

Anita Ramanathan examines the importance of inclusivity and diversity throughout the drug discovery and development process. . These observations may come to light in the clinic, but these disparities can be attributed to every phase of the drug development pipeline – clinical trials, translational research and, ultimately, drug discovery.

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Drug Discovery World

FEBRUARY 2, 2023

Bryan Oronsky , Chief Development Officer at EpicentRx, discucsses how one drug sourced from the defense and aerospace industry, could have many potential disese targets. A late-stage clinical trial in head and neck cancer for the treatment of severe oral blistering or oral mucositis caused by radiation therapy is planned.

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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.

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Delveinsight

SEPTEMBER 8, 2021

From discovery to development and production of any biological product, aid in decision making is given by Pharma Consultants. A pharmaceutical consultant provides companies with expert advice on pharmaceutical development and sales. Different areas where Pharma Consultancies provide aid are: Business Development.

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Pharmaceutical Technology

MAY 11, 2008

Over the last three to five years technology has been developed that makes it possible to track and trace pharmaceutical units, even down to item level. ” Laser marking solution company Datalase has developed a system where an inactive compound can be added to the tablet formulation.

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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”?

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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

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Pharmaceutical Technology

MARCH 22, 2023

Several drug development trends are driving injectables demand. A poor choice of closure or a dimensional defect on a packaging component can impact the container’s integrity, causing leaks, oxidation, and/or contamination. This was higher than the number of approvals in 2019 and 2020.

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XTalks

OCTOBER 16, 2020

The drug was developed by biotech company Regeneron Pharmaceuticals, Inc. However, that outbreak was controlled before Regeneron’s drug could be tested in a clinical trial. Inmazeb is a combination of three different antiviral monoclonal antibodies. Related: First Ebola Vaccine Cleared by European Commission.

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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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Pharmaceutical Technology

MAY 24, 2023

Xacduro was originally developed by Entasis Therapeutics. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046). The bacterial species is commonly spread in healthcare facilities through direct contact between hands and contaminated surfaces, causing further risk to patients.

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Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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