Collaborative Drug

SEPTEMBER 28, 2023

Recorded Webinar: Manage Protocol/Assay Definitions in CDD Vault Dive deep into the latest advancements for managing biological assay data within the CDD Vault.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Does this guidance offer the formal definition of “orphan device” we’ve been waiting for?

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Trials Marketing Clinical Trials Regulations 40

Agency IQ

OCTOBER 6, 2023

The EPA has a new, enforceable definition for PFAS. As part of its new PFAS reporting rule, the Environmental Protection Agency has published a newly enforceable definition of PFAS that significantly increases the number of chemicals covered by the definition, and therefore, the rule. What does it actually cover?

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Collaborative Drug

AUGUST 24, 2023

Vault Snack #20 - Manage Protocol/Assay Definitions in CDD Vault

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Eye on FDA

DECEMBER 15, 2021

It would seem that Omicron has rendered that definition outmoded. Because so many decisions, both institutional and personal, rely on that definition, it is clear that it needs to be changed to incorporate the role of additional vaccination.

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Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

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Trials Clinical Trials Marketing 52

Drug Channels

JUNE 13, 2024

Today’s guest post comes from Christine Juday, Head of Market Access at Real Chemistry. Chris discusses new research on how patients perceive out-of-pocket costs. As she explains, many patients and unpaid caregivers consider out-of-pocket costs for medication within the context of their total spending.

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Collaborative Drug

APRIL 15, 2024

Vault Snack #22 – Importing Raw File Formats

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The Pharma Data

OCTOBER 22, 2020

CDC Broadens Definition of ‘Close Contact’ in Tracing COVID-19 Infections. State and local health departments rely on this definition to conduct contact tracing, The Post reported. Professional. THURSDAY, Oct. 22, 2020 — In a move that widens the pool of people considered at risk for COVID-19 infection, U.S.

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Disease 52

Drugs.com

OCTOBER 13, 2023

THURSDAY, Oct. 12, 2023 -- A new guideline from four leading medical organizations should help doctors determine if someone is brain dead. “Until now, there have been two separate guidelines for determining brain death, one for adults and one.

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The Pharma Data

SEPTEMBER 8, 2021

Roche today announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. The acquisition enables Roche to further expand the portfolio of currently over 45 CE-IVD assays and more than 100 research use assays on Roche`s LightCycler PCR instruments.

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Virus Assay Development Disease Research 52

Drug Discovery World

JUNE 4, 2024

Aspects of the programme will see companies work with experts to develop comprehensive commercialisation plans for areas including market space definition, proposition framing, customer definition, distribution, marketing and sales, IP management, and funding.

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Science Daily: Pharmacology News

APRIL 24, 2024

Researchers have invented a new optical element that brings us one step closer to mixing the real and virtual worlds in an ordinary pair of eyeglasses using high-definition 3D holographic images.

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Research 122

Science Daily: Pharmacology News

SEPTEMBER 25, 2023

The Gulf Stream transport of water through the Florida Strait has slowed by 4% over the past four decades, with a 99% certainty that this weakening is more than expected from random chance, according to a new study.

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Collaborative Drug

APRIL 26, 2024

New Interface for Protocol Readout Definitions We are excited to announce a new, modern GUI for creating Protocol readout definitions in CDD Vault. Key Features: Modular Approach to Readout Definitions: Dose-Response:: Users must define their concentration and raw data values independently.

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BioPharma Drive: Drug Pricing

JANUARY 2, 2024

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

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Clinical Trials Trials Disease 143

Fierce BioTech

JUNE 20, 2024

2024 Life Sciences Industry Outlook The definitive report on the state of our industry. lbarrick Thu, 06/20/2024 - 13:16 The definitive report on the state of our industry.

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Science 52

Drug Discovery World

DECEMBER 7, 2023

Our work with Neumora is the very definition of translational research and the work we aim to do every day, which is applying innovation and discovery to help address the world’s most complex challenges.”

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Agency IQ

APRIL 12, 2024

There are a wide variety of definitions for PFAS and consistent debate on which definition is most applicable. Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s. Fill out the form to read the full article.

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Cytel

APRIL 22, 2024

Each definition of probability of success has benefits and limitations both in the way it is measured, and the way it is accounted for in study design and execution.

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Clinical Trials Trials Production Clinical Development 59

Drug Discovery World

JANUARY 16, 2024

It is enabling computational protein design for vaccine immunogen discovery, and high-throughput and high-definition assays for quicker and more comprehensive characterisation of vaccine candidates and vaccine-elicited immunity. “Technology plays multiple roles in all stages of vaccine development,” Kanekiyo said. “It

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

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Drug Discovery World

MARCH 7, 2024

Biotechnology company Akari Therapeutics and biopharmaceutical company Peak Bio have announced a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX.

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Clinical Trials Licensing Licensing Clinical Development 147

The Pharma Data

JANUARY 24, 2021

Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. Following completion of the transaction Sairiyo will be a wholly-owned subsidiary of the Company.

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Drugs.com

JULY 19, 2023

WEDNESDAY, July 19, 2023 -- A definitive diagnosis of Alzheimer’s disease now requires a series of complicated and expensive imaging scans that look for abnormal protein plaques and tangles in the brain. But in the near future, detecting signs of.

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Drug Discovery World

AUGUST 30, 2023

The comprehensive process engaged with over 30 potential counterparties, including more than 20 potential strategic acquirers before entering into a definitive agreement with Danaher.

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Science Drugs Research 130

Drugs.com

SEPTEMBER 18, 2023

18, 2023 -- Perhaps succumbing to fraudsters or facing mounting bills, older Americans begin losing wealth in the years preceding a definitive dementia diagnosis, new research shows. MONDAY, Sept. For example, the median household net worth of the.

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Research 89

Perficient: Drug Development

MARCH 29, 2024

While SQL encompasses a wide array of commands, understanding the distinctions between Data Manipulation Language (DML), Data Definition Language (DDL), and Data Control Language (DCL) is fundamental for wielding this powerful tool with finesse. DDL: DDL stands for Data Definition Language.

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Drugs.com

NOVEMBER 7, 2023

That provides some of the first definitive evidence that executive function matures by that time. MONDAY, Nov. 6, 2023 -- An adolescent starts thinking like an adult right around the age of 18, according to new research. Executive function is a.

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Research 75

FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

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SCIENMAG: Medicine & Health

AUGUST 3, 2023

Given this scenario, their correct definition and characterization become a key element in defining possible future scenarios. The climate crisis is severely affecting marine ecosystems around the world and the Mediterranean is not an exception. Credit: Copernicus / ICM-CSIC The […]

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Science 84

NIOSH Science Blog: Drugs

MAY 14, 2024

There are no commonly accepted definitions for traditional or for nonstandard (also referred to as alternative) work arrangements. Among the changes anticipated in the Future of Work is an increasing prevalence of nonstandard work arrangements, such as contingent, platform-based, seasonal, on-call, or other “nonstandard” work.

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Research 58

BioPharma Drive: Drug Pricing

JANUARY 12, 2024

Regulators will continue to evaluate suicide ideation as the data don't "definitively rule out" an association.

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FDA Regulations Drugs 64

Agency IQ

MARCH 15, 2024

Today, the agency published a draft version of those “select updates,” which delineate how the FDA will interpret key statutory definitions and provide expectations for documentation and for bringing existing devices into compliance. Fill out the form to read the full article.

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Advarra

MARCH 5, 2024

This leaves it up to individual institutional review boards (IRBs) to establish a definition, policies/procedures, and reporting requirements for sponsors, contract research organizations (CROs), and investigative sites to follow. Understandably, this can cause confusion for researchers working with multiple IRBs.

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Regulations Clinical Research Research Government 52

Science Daily: Pharmacology News

OCTOBER 17, 2023

Researchers say they have found 'definitive' archaeological evidence that seaweeds and other local freshwater plants were eaten in the mesolithic, through the Neolithic transition to farming and into the Early Middle Ages, suggesting that these resources, now rarely eaten in Europe, only became marginal much more recently.

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Research 76

FDA Law Blog: Biosimilars

JUNE 13, 2024

Though the Court acknowledged that the definition of the term “drug” is broad enough to include the ProAir HFA inhaler, the Court found that “this broad statutory definition of drug does not suffice to establish the Inhaler Patents claim the drug for which Teva submitted its application.”

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