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

Drugs.com

OCTOBER 25, 2023

25, 2023 – A new, more inclusive definition of infertility has been crafted by the American Society for Reproductive Medicine (ASRM). WEDNESDAY, Oct. While the guidance for heterosexual couples with medical reasons for being unable to.

Doctors 64

Doctors 64

Collaborative Drug

APRIL 15, 2024

Vault Snack #22 – Importing Raw File Formats

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FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Drugs 59

Drugs Pharmaceuticals Regulations 59

Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.”

FDA 59

FDA Regulations Marketing 59

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.

Clinical Trials 143

Clinical Trials Trials Disease 143

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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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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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.

Research 119

Research 119

Drugs.com

DECEMBER 5, 2024

5, 2024 -- “An ounce of prevention is worth a pound of cure,” founding father Benjamin Franklin once said.That’s definitely true of cancer, a new study has found.Cancer prevention and screening has saved more people from five types of. THURSDAY, Dec.

Treatment 94

Treatment 94

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

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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85

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.

FDA 105

FDA Compliance Regulations Engineering 105

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.

Vaccine 93

Vaccine 93

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

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.

Treatment 102

Treatment Drugs 102

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 82

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.

Clinical Trials 97

Clinical Trials Trials Clinical Research International 97

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.

Regulations 109

Regulations Government Marketing Compliance 109

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.

Marketing 52

Marketing Research Drugs 52

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.

Disease 93

Disease 93

Drug Target Review

DECEMBER 20, 2024

” Weve definitely come across people in the pharma industry who worry that AI means companies might steal our data or use it in harmful ways. Smith states, weve definitely come across people in the pharma industry who worry that AI means companies might steal our data or use it in harmful ways.

Clinical Trials 117

Clinical Trials Trials Pharmaceuticals Drug Development 117

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.”

FDA 95

FDA Regulations Production Small Molecule 95

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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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.

Research 87

Research 87

FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

FDA 105

FDA Regulations Production Drugs 105

Science Daily: Pharmacology News

SEPTEMBER 19, 2023

This seemingly simple question has been studied extensively over the past decades, but a definitive answer has long been elusive. At what age are people at their happiest? A research team has now shed light on the question in a comprehensive meta-analytic review.

Research 90

Research 90

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 […]

Science 84

Science 84

BioPharma Drive: Drug Pricing

JANUARY 12, 2024

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

FDA 69

FDA Regulations Drugs 69

Chemical Biology and Drug Design

MAY 11, 2023

The physicochemical properties of benzomorphan N -substituent are crucial in achieving a definite pharmacological profile at opioid receptors. Abstract 6,7-Benzomorphans have been investigated in medicinal chemistry for developing new drugs. This nucleus could be considered a versatile scaffold.

Drugs 100

Drugs Research 100

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.”

FDA 116

FDA FDA Approval Production Drugs 116

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.

Research 75

Research 75

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.

Regulations 59

Regulations Compliance 59

ASPET

NOVEMBER 2, 2023

Gabapentinoids have clinically been used for treating epilepsy, neuropathic pain, and several other neurological disorders for >30 years, however, the definitive molecular mechanism responsible for their therapeutic actions remained uncertain.

Regulations 100

Regulations Drugs 100

ASPET

NOVEMBER 2, 2023

CYP2E1-mediated metabolism to the hepatotoxic reactive metabolite NAPQI (N-acetyl-p-benzoquinone imine) is a minor metabolic pathway that has not been clearly linked to AAP therapeutic benefits yet definitely leads to AAP liver toxicity.

Therapies 100

Therapies Treatment 100

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions.

FDA 105

FDA Regulations Marketing Drugs 105

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.

Clinical Trials 59

Clinical Trials Trials Production Clinical Development 59