2001, Pharmaceuticals, Regulations and Trials

2001

Pharmaceuticals

Regulations

Trials

Report: huge inequalities in access to myeloma clinical trials in Europe

Drug Discovery World

DECEMBER 6, 2022

Myeloma Patients Europe (MPE) has launched an advocacy report on addressing access barriers to myeloma clinical trials in Central and Eastern Europe (CEE). . The MPE report presents clinical trial analytics, looking at the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020.

Clinical Trials

Clinical Trials Trials Nurses International

Can Europe become a major player in cell and gene therapy?

Drug Discovery World

NOVEMBER 24, 2022

A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment, particularly when it comes to Advanced Therapies Medicinal Products (ATMPs) like tissue, gene and cell therapies. .

Therapies

Therapies Clinical Trials Pharmaceuticals Government

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Trending Sources

Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Drug development and clinical trials: How drugs are discovered and developed as medicines.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Tonix Pharmaceuticals Holding Corp.

Pharmaceuticals

Pharmaceuticals Small Molecule Vaccine Protein Expression

Chipscreen and HISUN reach a strategic cooperation

The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. in 19 provinces and regions in China. in 19 provinces and regions in China. It also provides potential liver protection.

Pharmaceuticals

Pharmaceuticals Small Molecule Clinical Trials Production

Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

Trials

Trials Clinical Trials Therapies Regulations

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role. Ther Innov Regul Sci. 2001 Sep;24(9):517–26. Regul Toxicol Pharmacol RTP. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al.

Drugs

Drugs FDA Disease Animal Testing

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

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

Science FDA Packaging Production

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. Medicis Pharmaceutical Corp. , 2001), relied on these other statutes to hold that a road could not be a “product”). at 77 (citation omitted). In United States v. Brown , 348 F.3d Accord Stark v.

Production

Production International Trials Government

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

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

Testimonials Trials Science Government

Yet Another Update on Medical Abortion Litigation: PhRMA’s Amicus Brief in Support of Petition for U.S. Supreme Court Review of the Fifth Circuit Decision

Drug & Device Law

OCTOBER 20, 2023

LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. 341 (2001), is so important. FDA/Alliance for Hippocratic Medicine v.

FDA

FDA FDA Approval Pharmaceuticals Clinical Trials

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Here, Plaintiff concedes that some of the proposed designs. . .

FDA

FDA FDA Approval Testimonials Vaccine

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S.

FDA

FDA Regulations Production Government

Drug Discovery Digest

Report: huge inequalities in access to myeloma clinical trials in Europe

Can Europe become a major player in cell and gene therapy?

Trending Sources

Preparing the next generation of drug discovery scientists

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

Chipscreen and HISUN reach a strategic cooperation

Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union

Human neuronal cells: possibilities in drug safety testing

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

How the Fifty States View Electronic Data as a “Product”

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Yet Another Update on Medical Abortion Litigation: PhRMA’s Amicus Brief in Support of Petition for U.S. Supreme Court Review of the Fifth Circuit Decision

The FDA and Feasible Alternative Designs

Logical Contradiction Doctrine: Buckman for Textualists

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