PPD

OCTOBER 17, 2024

Drug developers of all sizes are working to optimize each step in the clinical research process from site selection to complex logistics, managing evolving regulations, and patient recruitment and retention strategies. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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Drug Target Review

AUGUST 24, 2023

Infiltration of immune cells into tissues follows a cascade of events, namely rolling, activation, adhesion and transmigration, which are mediated by different molecules. Cell adhesion molecules and their roles and regulation in the immune and tumor microenvironment. Cancer Immunology Research. 2021 Dec 1;9(12):1425-38.

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Treatment Therapies Clinical Development Cell Biology 98

Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec. Contact: Tauriga Sciences, Inc.

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SugarCone Biotech

JUNE 10, 2024

[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. This is where things get interesting due to the complexity of the immune system and its regulation.

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Immune Response Production Regulations Clinical Trials 87

The Pharma Data

JUNE 28, 2021

It was studied specifically in patients who have experienced a recent worsening heart failure event, meaning a recent hospitalization for heart failure or the use of intravenous diuretics, in order to reduce the risk of further worsening events. Verquvo (vericiguat) was approved by the U.S. About Vericiguat Vericiguat 2.5

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. View source version on accesswire.com: [link].

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Clinical Trials Clinical Development Clinical Supply Trials 52

The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Source link.

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Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

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The Pharma Data

JANUARY 19, 2021

The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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Clinical Trials Trials Clinical Development Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 11, 2021

Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. In September 2021, Wegovy was approved by the UK Medicines and Health products Regulations Agency (MHRA). Wegovy was launched in the US in June 2021 following approval by the U.S.

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Treatment Disease Clinical Trials Trials 52

The Pharma Data

AUGUST 18, 2020

And it’s not yet certain whether Beijing will help cover some of the costs for a pandemic vaccine developed by a state-run company. Virtual Event. DEVELOP A UNIFIED SCIENTIFIC VOICE. That roughly translates into $4 per dose, though the entire grant also covers funding for clinical development. government.

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The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. GSK is a science-led global healthcare company.

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The Pharma Data

OCTOBER 18, 2020

Observed adverse events (AEs) showed to be generally consistent with previous studies of guselkumab and current Summary of Product Characteristics. Both studies showed significant improvements in quality of life physical and mental component scores, and in both studies, guselkumab was well tolerated through week 24. References: 1.

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Treatment Clinical Development Therapies Production 40

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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Small Molecule Clinical Development Production Science 40

The Pharma Data

JANUARY 24, 2021

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. About Citius Pharmaceuticals, Inc. .

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The Pharma Data

JANUARY 25, 2021

“The technology has a unique pharmacological profile, which is very different from other products in preclinical and clinical development in that it focuses on restoring function. All clinical development plans are subject to additional funding. ” Dr. Corey Davis Ph.D.,

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Disease Clinical Development Molecular Biology Treatment 40

Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. INVESTOR AND MEDIA CONTACTS Innovation Pharmaceuticals Inc. Leo Ehrlich info@ipharminc.com.

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Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

JUNE 1, 2022

Zuranolone 50 mg was generally well-tolerated and demonstrated a safety profile consistent with that observed in the clinical development program to date. In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. Food & Drug Administration.

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Biosimilars Treatment Therapies Disease 52

The Pharma Data

JULY 27, 2021

As part of the collaboration, working together with AbbVie, Calico pursues discovery-stage research and development utilizing state-of-the-art technology and advanced computing capabilities. AbbVie provides scientific and clinical development support and will lend its expertise to future commercialization activities.

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The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar.

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The Pharma Data

AUGUST 29, 2020

LNP023 also demonstrated a favorable safety and tolerability profile with no serious treatment-related infections or thromboembolic events. Following the cut-off date for the presented data, one participant, who had severe lymphopenia at study entry, discontinued treatment due to a serious adverse event (AE) of lymphoproliferative disorder.

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Treatment Disease Small Molecule Production 52

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval.

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

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Clinical Trials Trials Disease Therapies 52

The Pharma Data

JANUARY 4, 2021

Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. relevant government policies and regulations relating to our industry. “We believe Prof.

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Therapies Molecular Biology Immune Response Science 40

The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Structure Based Drug Design (SBDD) Targeted Protein Degradation Drugs Disease 52

The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Amgen, along with members of?Amgen’s

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Clinical Trials Production Trials Government 52

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. NASH Investor Event Information. A replay of the event will be available on Poxel’s website following the presentation.

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The Pharma Data

OCTOBER 14, 2020

About VBL’s VB-600 Platform VBL is conducting two parallel drug development programs that are exploring the potential of MOSPD2 (motile sperm domain-containing protein 2), a protein that VBL has identified as a key regulator of cell motility, as a therapeutic target for inflammatory diseases and cancer. Source link.

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Treatment Clinical Trials Small Molecule Trials 40

The Pharma Data

JANUARY 18, 2021

His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. Enquiries: OKYO Pharma Limited. Gary S. Jacob, Chief Executive Officer.

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Science Virus Treatment Disease 40

The Pharma Data

OCTOBER 18, 2020

Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies.

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The Pharma Data

OCTOBER 28, 2020

Preliminary results from the first five patients treated indicate substantial improvements in all patients in at least two disease domains including communication, behavior, sleep, gross motor function, and fine motor function as measured by the Clinical Global Impression of Improvement Scale for Angelman Syndrome (CGI-I-AS) at day 128.

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