Drug Discovery World

OCTOBER 5, 2022

The market is growing strongly as accelerated technological, material, and methodological developments expand the potential applications for 3D bioprinting. RA: How regulated is bioprinting and is there more work needed with regulators to make it more accessible?

Pharmacogenetics 130

Pharmacogenetics Regulations Drugs Therapies 130

Drug Discovery World

FEBRUARY 22, 2023

Craig Caceci, Managing Director at Terebellum, offers guidance to pharmaceutical companies that are in the position to take their drugs to market. Market access is more difficult and supply is focused on smaller patient populations which brings its own set of challenges. before 18 months.

Specialty Pharmacies 130

Specialty Pharmacies Drugs Marketing Clinical Trials 130

Fierce BioTech

JUNE 22, 2023

In this webinar we hear from industry leaders, including a leading specialty pharmacy in Europe, on how they provide healthcare services including digital solutions to people living with a rare disease, to help them get the best outcomes from their medication. Click here to login. Listing Image Sciensus-LogoListing-8022023.png

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Drugs Disease 52

FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

FDA 111

FDA Production Trials Pharmacy 111

Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. As Crary ( 2013 , p.

Pharmacy 52

Pharmacy Regulations Production Marketing 52

FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. The assessment is to be based solely on the reporting manufacturer’s capacity and supply without regard to other manufacturers’ capacity or market demand.

FDA 59

FDA Production Marketing Pharmacy 59

The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S. More than 34 million people in the U.S.

Biosimilars 52

Biosimilars Production FDA Approval FDA 52

The Pharma Data

MAY 27, 2022

It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”. market and are made at facilities in Europe — amounts to more than 5 million full-size, 8-ounce bottles. “We continue to work closely with our U.S. as quickly as possible.

FDA 52

FDA Specialty Pharmacies Pharmacy Production 52

The Pharma Data

MAY 7, 2021

Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). International regulators and WHO call for wider public access to clinical data ( EMA ). International regulators and WHO call for wider public access to clinical data ( EMA ). What happens now?

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

Perficient: Drug Development

MARCH 19, 2024

See Also: Perficient Mentioned in Two Forrester Reports on Tech-Enabled Clinician Experiences Healthcare Trend #4: Experiences That Build Trust Historically, healthcare has experienced higher-than-average levels of consumer trust compared to other market sectors.

Pharmacy 52

Pharmacy Nurses Marketing Engineering 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g., billion for pseudoephedrine.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis of a recent listening session on the topic here. ].

FDA 40

FDA Trials Regulations Therapies 40

The Pharma Data

MAY 13, 2021

‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs ( STAT ). A non-opioid pain startup believes it can top the bupivacaine market — and it’s thinking in terms of weeks, not days ( Endpoints ). Pharma & Biotech. Medtech.

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

The Pharma Data

JANUARY 17, 2021

Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries. And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Clinical Trials 52

Clinical Trials Treatment Trials Hospitals 52

The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If Healthy kidneys act as the body’s filter, removing waste products from the blood.

Clinical Development 52

Clinical Development Disease Clinical Trials Trials 52

The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. ” Prof. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD. “Hugh Rogers” Hugh Rogers, CEO and Director.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness. Interestingly, Merck & Co.

FDA 40

FDA Science Drugs Regulations 40

The Pharma Data

JANUARY 24, 2021

The global esophageal cancer drugs market is estimated to grow by USD $1.5 Persons”, as such term is defined in Regulations under the U.S. Sairiyo is currently focused on advancing the clinical development of Cepharanthine to treat rare cancer diseases. billion during 2019-2023 (Technavio 2019).

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

Drugs 45

Drugs Biosimilars Production Treatment 45

Drug Discovery World

JULY 27, 2023

Companies and industry groups identified that there may be the chance for increased flexibility on the amount of time it takes for new products to be approved; but accepted that this would be offset by the need for separate EU and UK approvals for market access.”

Government 130

Government Drugs Science International 130

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. level, including the development of lists of critical medicines during major events that affect public health.

Regulations 40

Regulations Packaging Production FDA 40

Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

FDA 40

FDA Pharmacy Production Drugs 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Packaging Production 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. Moreover, the current landscape lacks comprehensive regulations specifically tailored to the use of AI in healthcare, leaving a gray area around the responsible deployment of LLMs. RBC Capital Markets. Accessed Jan 2024.

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

Speaking of improving data in RWD sources, the HITAC annual report also points directly to the need to improve two areas of structural challenge for the FDA: consistent data standardization for laboratories , and better connectivity of pharmacy data “with the broader health IT ecosystem.”

FDA 40

FDA Laboratories Pharmacy Government 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

Drugs 59

Drugs Regulations Government Vaccine 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. 1395w-114c(b)(4)(B)(i). had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop. Phage therapies are sold at a pharmacy in Georgia.

Therapies 121

Therapies Virus DNA Clinical Trials 121

Codon

APRIL 9, 2023

Read Probe-based bacterial single-cell RNA sequencing predicts toxin regulation. A programmable and red light-regulated CRISPR-dCas9 system for the activation of endogenous genes in Saccharomyces cerevisiae. The global VC market shrank by more than half in the first quarter of 2023 compared to the same time last year.

Therapies 52

Therapies RNA Engineering Vaccine 52

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.

FDA 40

FDA Science Clinical Trials Trials 40