Drug Discovery World

FEBRUARY 20, 2024

Industry experts explain how blockchain can fundamentally enhance clinical trials. Obtaining consent from patients or healthy volunteers is a fundamental requirement for enrolling participants on to clinical trials. Along the study, patients are usually reconsented multiple times following a change in the trial protocol, eg.

Clinical Trials 130

Clinical Trials Pharma Companies Trials Compliance 130

The Pharma Data

DECEMBER 15, 2020

Founded in 2003, Athenex, Inc. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros. For more information, please visit almirall.com. About Athenex, Inc.

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

Drug Target Review

MAY 18, 2023

Results of the Multicenter Study of Hydroxyurea in Sickle Cell Anaemia published in the Journal of the American Medical Association in 2003, indicated that the use of hydroxyurea, the only drug approved at the time, reduced mortality as it reduced pain crises and increased foetal haemoglobin.

Disease 80

Disease Clinical Trials Drugs Trials 80

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. from 2003 to 2006, covering the biotechnology and life-science tools sectors.

Therapies 104

Therapies Engineering Molecular Biology Immune Response 104

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 1, 2023

The linchpin of our proposed language, or anything similar, is – of course – the requirement that trial judges act as “gatekeepers” to preclude the admission of inadequately supported – under whatever test a particular jurisdiction applies – expert opinions. So we did it by state. Ex parte George , So.3d 3d , 2021 WL 68997, at *23 (Ala.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. Lederle Laboratories recognized that courts, generally, are “reluctan[t]. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

NOVEMBER 16, 2023

The trial court ordered JAMA to produce a privilege log and copies of the documents for in camera review. GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). After the court concluded that the documents were covered by the privilege, the plaintiff filed a motion to divest JAMA of the privilege, which is conditional under Illinois law.

Government 64

Government FDA Pharmaceutical Companies Regulations 64

Drug & Device Law

MARCH 28, 2022

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. 2003 WL 22416000, at *4 (E.D. at *13 (citations and quotation marks omitted). In Sadler v.

Testimonials 59

Testimonials FDA Regulations Production 59