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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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 Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China.

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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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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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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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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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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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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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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

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. ” All 34 patients (100%) experienced at least one adverse event (AE), and 15 (44%) experienced a serious adverse event (SAE).2 The BCL-2 family of proteins are known regulators of the apoptosis pathway.3

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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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The Pharma Data

NOVEMBER 11, 2021

The VICTOR study will explore the efficacity of vericiguat in habitual heart failure cases and reduced ejection bit of 40 percent or lower who haven’t had a recent worsening HF event, a population similar to those of several other recent heart failure studies. Grounded on the VICTORIA study, vericiguat was lately approved in theU.S.,

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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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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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Drug Target Review

OCTOBER 10, 2024

Diseased cells can respond differently to treatment, leading to unforeseen adverse events, including severe toxicity and even death. Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinical development and escalate costs.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Persons”, as such term is defined in Regulations under the U.S.

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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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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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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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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 ).

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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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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.

Molecular Biology 40

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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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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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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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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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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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The Pharma Data

JANUARY 4, 2021

The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). ” Reference. Cancer Treatment and Survivorship Statistics, 2014.

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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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The Pharma Data

OCTOBER 25, 2020

BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. These forward-looking statements are based on management’s current expectations and beliefs.

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