The ChEMBL-og

APRIL 16, 2024

The definition of a chemical probe has been amended to update the field MOLECULE_DICTIONARY.CHEMICAL_PROBE.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

FDA 59

FDA Biosimilars Production Regulations 59

The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

FDA Approval 52

FDA Approval Therapies Small Molecule FDA 52

FDA Law Blog: Biosimilars

MAY 15, 2023

A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law. The goal is to create uniformity to facilitate interstate commerce.

Regulations 45

Regulations FDA Approval FDA Production 45

The Pharma Data

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus.

Laboratories 52

Laboratories FDA Approval Hospitals Regulations 52

Advarra

JULY 27, 2022

A better understanding of which post-approval changes should result in a regulatory submission. The definition of the levels of reporting categories for such changes. Products affecting regulatory pathways are typically already approved. However, obtaining approval will take a bit of time – up to a year.

Production 52

Production Pharmaceuticals FDA Approval FDA 52

The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

Treatment 52

Treatment FDA Approval FDA Therapies 52

Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Codon

JULY 14, 2024

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks.

Production 140

Production Clinical Trials Trials Therapies 140

The Pharma Data

JUNE 26, 2021

The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ?50% Patients must have metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation.

Treatment 52

Treatment Trials Disease FDA Approval 52

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

Drugs 59

Drugs Regulations International Production 59

The Pharma Data

JULY 15, 2021

EFS was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause. KEYTRUDA is currently approved under accelerated approval in the U.S. 10) as determined by an FDA-approved test.

Therapies 52

Therapies Treatment Trials FDA 52

sptlabtech

JUNE 27, 2022

Farruk Kabir | NGS Lab Manager | Aperture NextGen Laboratories Aperture NextGen Laboratories is an FDA approved CLIA lab for interdisciplinary clinical testing and research. We can do that, and it's definitely a good idea."

Laboratories 52

Laboratories FDA Approval RNA FDA 52

The Pharma Data

OCTOBER 27, 2021

Kymriah was preliminarily granted orphan medicinal product designation by the European Commission (EC) forFL.However, Kymriah would have the occasion to present an important treatment option for those cases with r/ r FL in need of potentially definitive issues, If approved in this implicit third suggestion.

FDA 52

FDA Treatment Trials FDA Approval 52

The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. [ii] Related Articles: Veklury (remdesivir) FDA Approval History. Published online on October 8, 2020.

Science 52

Science Clinical Trials Hospitals Trials 52

Eye on FDA

APRIL 15, 2020

But a new drug launch in the time of COVID-19 comes with definite challenges. Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. Recently in the U.S.

Therapies 55

Therapies Treatment FDA Approval Laboratories 55

The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

JANUARY 5, 2021

Radius” or the “Company”) (Nasdaq: RDUS) today announced a definitive agreement to acquire the global development and commercialization rights to Benuvia Therapeutics Inc. ’s PWS is an orphan disease with major endocrine and behavioral manifestations and no FDA-approved therapies for the treatment of hyperphagia.

Disease 52

Disease FDA Approval Clinical Trials Trials 52

Vial

JUNE 12, 2024

Role of PROs in drug approvals A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs. Such complications may otherwise be missed if only disease-specific PROs are used.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Molecular Design

OCTOBER 14, 2018

An 'unofficial' definition for the term PAINS has actually been published and I think that it's pretty good: "PAINS, or pan-assay interference compounds, are compounds that have been observed to show activity in multiple types of assays by interfering with the assay readout rather than through specific compound/target interactions."

Screening Hits 52

Screening Hits FDA Approval Drugs FDA 52

Drug Target Review

OCTOBER 17, 2024

This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. The first patient has been dosed in the last quarter.

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

The Pharma Data

JANUARY 22, 2021

Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care. NEW YORK , Jan. Lupus Research Alliance President and CEO Kenneth M.

Research 52

Research Treatment FDA Approval Disease 52

Advarra

JANUARY 23, 2024

FDA approval of a new drug for the condition under study) Impact of participation on alternative therapies (e.g., IRB Review of Minor Study Changes Federal regulations and guidance do not provide a singular definition for “minor” changes to research. a data breach) Decrease in expected benefits to participation (e.g.,

Research 52

Research Therapies FDA Approval Regulations 52

Practical Cheminformatics

FEBRUARY 1, 2023

As of 2021, there are over 70 FDA-approved drugs that are kinase inhibitors. Some examples of FDA-approved kinase inhibitors include imatinib (Gleevec), dasatinib (Sprycel), and lapatinib (Tykerb). While this can provide a small degree of confidence, it's far from definitive.

FDA Approval 52

FDA Approval FDA Drugs Science 52

The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. CDC widens definition of ‘close contact’ for tracking COVID infections. It is given intravenously to hospitalized patients.

Hospitals 52

Hospitals Virus FDA Government 52

Agency IQ

NOVEMBER 3, 2023

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community.

Therapies 40

Therapies Science FDA Production 40

Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? Q: What is the definition of a drug? A: It depends, but the answer is usually yes.

Packaging 52

Packaging FDA Trials Regulations 52

The Pharma Data

OCTOBER 24, 2020

Remdesivir gets full FDA approval to treat COVID-19. Remdesivir’s full approval Thursday by the U.S. The FDA also has given emergency authorization to using the blood plasma of survivors, and two companies are seeking emergency authorization for experimental antibody drugs.

Hospitals 52

Hospitals Virus FDA Government 52

Agency IQ

JUNE 7, 2024

Dietary supplements are intended for ingestion only, meaning that products that are administered through other routes, such as topically, by injection or by inhalation, do not fall within this definition. L-glutamine offers an example of a more recently approved drug product. One longstanding example is the laxative senna.

FDA 40

FDA Science Production FDA Approval 40

The Pharma Data

DECEMBER 10, 2020

Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges. and its affiliate NantKwest, Inc.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

Agency IQ

MAY 17, 2024

Following FDA approval, these products are granted seven years of marketing exclusivity, preventing FDA from approving the “same drug for the same disease or condition” if the applicant does not have the right to reference the product (i.e., DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.), TAMMY BALDWIN (D-Wisc.).

FDA 40

FDA Disease FDA Approval Production 40

The Pharma Data

APRIL 27, 2021

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7).

Vaccine 52

Vaccine Production FDA Disease 52

Agency IQ

JULY 8, 2024

One of these major changes was the addition of an entirely new section on medical gases to the Food, Drug, and Cosmetic (FD&C) Act, including a new definition of medical gases as drugs that are “manufactured or stored in a liquefied, nonliquefied, or cryogenic state” and are administered as a gas.

FDA 40

FDA Regulations Production Packaging 40

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. Definition of High-Risk Patients. REGN-COV2 (casirivimab and imdevimab) FDA Approval History.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

JANUARY 20, 2021

Approximately 1 in 10 people living with ILD cannot be given a definitive diagnosis, even after a thorough investigation, and in these cases, they are categorized as having unclassifiable interstitial lung disease (UILD). Esbriet was FDA-approved for use in people with IPF in October 2014. About the Pivotal Study. About Esbriet.

FDA 40

FDA Disease Doctors Treatment 40