Antidote

APRIL 23, 2024

Equitable access to medical care is valuable for everyone, and an important part of this equation is health literacy. Health literacy encompasses not just access to medical care, but also the ability to understand and use medical guidance.

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Science Daily: Pharmacology News

JUNE 12, 2024

Goldenrod can perceive other plants nearby without ever touching them, by sensing far-red light ratios reflected off leaves. When goldenrod is eaten by herbivores, it adapts its response based on whether or not another plant is nearby. Is this kind of flexible, real-time, adaptive response a sign of intelligence in plants?

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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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FDA Law Blog: Biosimilars

APRIL 3, 2023

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). All of these products are line extensions under CMS’s definition. Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist. times that of Medicaid ( $98 billion and $38.1

Drugs 57

Drugs Regulations Production Marketing 57

Collaborative Drug

AUGUST 24, 2023

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

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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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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.

Vaccine 72

Vaccine Nurses Virus Treatment 72

DrugBaron

OCTOBER 17, 2022

Asset-centric is a term coined by Medicxi founding partner Francesco De Rubertis to describe an investment strategy he pioneered, together with Kevin Johnson and Michele Ollier, in the early years of the 21 st Century. The key was focusing investment on a single asset to avoid the problem with pipelines in early-stage biotech companies.

Pharma Companies 100

Pharma Companies Pharmaceuticals Drug Development Production 100

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?

Regulations 40

Regulations Government Science Production 40

Agency IQ

MAY 10, 2024

FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. That draft guidance came out in 2021.

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FDA Regulations Compliance Production 40

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.

Trials 52

Trials Clinical Trials Marketing 52

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.

Disease 52

Disease 52

Collaborative Drug

APRIL 15, 2024

Vault Snack #22 – Importing Raw File Formats

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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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Marketing Research Drugs 52

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.

Virus 52

Virus Assay Development Disease Research 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.

Doctors 45

Doctors 45

Drugs.com

OCTOBER 31, 2024

31, 2024 -- Onions spread on McDonald's Quarter Pounders are the definite source of an outbreak of E. THURSDAY, Oct. coli illness that's now affected 90 people nationwide, new evidence from the U.S. Centers for Disease Control and Prevention.

Disease 105

Disease 105

Science Daily: Pharmacology News

NOVEMBER 18, 2024

The science of net zero, developed over 15 years ago, does not include these natural carbon sinks in the definition of net human-induced CO2 emissions. Yet governments and corporations are increasingly turning to them to offset emissions, rather than reducing fossil fuel use or developing more permanent CO2 disposal options.

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Government Science International 104

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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DrugBank

SEPTEMBER 12, 2024

Your Definitive Source of Truth The Data Dictionary is tailored to transform your data experience, offering the official DrugBank perspective on every piece of information in our database. Enhanced User Experience By offering immediate access to detailed data definitions, the Data Dictionary saves you time and reduces errors.

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Production Government Packaging Research 78

Drugs.com

SEPTEMBER 25, 2024

adults (38%) say they will definitely get a flu jab, and only one in four (26%) say. WEDNESDAY, Sept. 25, 2024 -- Most Americans don’t plan to get vaccinated against the flu or COVID-19 this season, a new survey has found.Fewer than two in five U.S.

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Vaccine 104

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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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 123

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

NIOSH Science Blog: Drugs

OCTOBER 23, 2024

NIOSH and OSHA do not currently have a standard definition of lone work. What is lone work? Based on information in the literature, and for the purpose of this blog, we are defining lone work as a potentially

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Collaborative Drug

SEPTEMBER 23, 2024

In order to view the AUC calculation, simply customize your search report and select ‘Area under the curve’ from your dose response curve readout definition options. This can be easily accomplished by adding a fit parameter (slope =1) in the plot readout definition and then removing it.

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Treatment Drugs 102

FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

The Court looked to the “statute’s words, structure, and historical context” and found that they “establish that, when Congress amended the [Orphan Drug Act] in 2017, it ratified and incorporated the existing regulatory definition of ‘same drug’ into the statute.”

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FDA Regulations Drugs International 109

Advarra

JUNE 18, 2024

When collecting this data, knowing if you have a strict definition of target versus actual and how system-wide your definitions are will greatly help. This is important because if you’re trying to do an analysis across your entire organization, and the definitions don’t line up, the data won’t make sense.

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Clinical Trials Trials Clinical Research International 97

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.

FDA 52

FDA Drugs Clinical Development Disease 52

Perficient: Drug Development

AUGUST 19, 2024

Traditional risk managers, by their job definition, are highly cautious of the result sets provided by the analytics teams. An additional understanding of how this would impact other forms of risk reporting, like credit risk and non-financial risk is definitely a nice to have. Notwithstanding the critical data elements.

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Regulations Government Marketing Compliance 109

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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Regulations Compliance 59

Drugs.com

SEPTEMBER 10, 2024

We found that women fulfilling the definition of asthma had a higher rate of fetal loss and a. TUESDAY, Sept. 10, 2024 -- Having asthma appears linked to raised odds for miscarriage and troubles with fertility among women, new Danish research shows.“We

Research 52

Research 52

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.

Science 52

Science 52

The Pharma Data

MARCH 14, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics (NASDAQ: GNMK) today announced that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of US$ 24.05 per share in an all-cash transaction. This corresponds to a total transaction value of approximately US$ 1.8

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Hospitals Disease Laboratories Treatment 52

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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FDA Compliance Regulations Engineering 104

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