The Pharma Data

JANUARY 7, 2021

a clinical-stage biopharmaceutical company, today announced that Xiaodong Yang , M.D., The Company’s presentation will be available on-demand from January 11 – 14, 2021. SAN CARLOS, Calif. , 7, 2021 /PRNewswire/ — Apexigen, Inc. , The Company will be conducting one-on-one meetings. About Apexigen.

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The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”.

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Fierce BioTech

MAY 29, 2024

Redefining Antibody Specificity Profiling for IND Assessment of antibody off-target reactivity is a regulatory requirement for clinical development, but conventional methods are often ineffective, and their predictive value for in vivo safety and toxicity is poor.

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The Pharma Data

SEPTEMBER 29, 2021

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that its CD40 targeting antibody mitazalimab will be presented at the World Immunotherapy Congress, November 2-6, 2020. The presentation will also summarize previously released clinical data from the Phase I study performed by Janssen Biotech Inc.

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The Pharma Data

JULY 28, 2021

The TAK-994 BTD was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients. 1 Currently, TAK-994 is being studied in an ongoing Phase 2 (TAK-994-1501) study.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. AR-301 (VAP). AR-101 (HAP).

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The Pharma Data

APRIL 12, 2022

20% variant allele frequency reduction – At the time of analysis with > 2 year follow up the survival estimate was 100% in patients who had improvements in bone marrow fibrosis or variant allele frequency – Results were presented at the American Association for Cancer Research annual meeting.

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The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer.

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The Pharma Data

FEBRUARY 24, 2022

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.

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The Pharma Data

OCTOBER 21, 2020

(Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present a poster on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Society of Nephrology (ASN) Kidney Week, Oct.

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The Pharma Data

NOVEMBER 14, 2020

The results were presented at The Liver Meeting Digital Experience (TLMdX), November 13–16, 2020 (Late Breaker #L02). The companies are also presenting preclinical data supporting the development of combination approaches in NASH. We are now carefully evaluating next steps together based on a thorough assessment of data.”.

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The Pharma Data

JUNE 2, 2023

Nasdaq: GILD) and Kite, a Gilead Company, will present 17 abstracts from its industry-leading cell therapy portfolio and growing blood cancer pipeline at the upcoming 2023 European Hematology Association (EHA) Annual Congress being held in Frankfurt, Germany, June 8-11, and virtually June 14-15. & SANTA MONICA, Calif.–(BUSINESS

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The Pharma Data

OCTOBER 28, 2020

Dr. Maurice Zauderer, chief executive officer of Vaccinex, will present, “Learnings from the SIGNAL Phase 2 Study of Treatment with Pepinemab Antibody,” at 10:00 am ET on Friday, October 30. These new data suggest that pepinemab has the potential to provide cognitive benefit and slow brain atrophy in HD patients.

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KIF1A

MARCH 16, 2024

The study identified 8 groups based on symptom presentation, and found over 70 disease-associated genes, including 4 patients with KIF1A mutations. While genetic disorders like KAND make up only a small part of this number, this represents the need for increased investment in neuroscience research and clinical development.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. Renowned lymphoma expert Mats Jerkeman, MD, Lund University, will give a presentation on the current treatment landscape, and unmet medical need for patients with relapsed or refractory NHL. CET ( 11:30 a.m.

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Drug Target Review

APRIL 9, 2024

Our approach to investigate the toxicity driven by nucleolar stress was to induce it with certain arginine-rich peptides, present in patients of ALS, which were known to accumulate at nucleoli and cause this type of stress. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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Drug Target Review

DECEMBER 28, 2023

These newly formed mutated proteins are called neoantigens and they are only present on tumour cells and are not found in normal, healthy cells. Findings from a leading-edge study called TRACERx have demonstrated how mutations that occur very early in the process of cancer genesis remain present in all cells of a growing tumour.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. One diagnostic example that I discussed in my presentation is autism. Enrolling adequate populations will be required to advance these programs.

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Drug Target Review

FEBRUARY 1, 2024

There are a lot of drug development challenges that are, in some cases, unique to neuroscience, including neurological diseases, psychiatric disorders, and rare diseases affecting the nervous system. Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.

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The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website. Wainberg, M.D.,

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. Factoring in cultural dynamics is key to enabling new therapy treatment success.

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The Premier Consulting Blog

JULY 9, 2023

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept.

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Drug Target Review

MAY 7, 2024

However, some biomarkers may only be present in a minority of patients, requiring a large patient population to identify such markers. Moreover, the application of synthetic control arms presents the opportunity to transform the trial process itself. Not all biomarkers have a limited prevalence.

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SCIENMAG: Medicine & Health

FEBRUARY 6, 2024

The Brain & Behavior Research Foundation (BBRF) is hosting a free webinar, “Developing Biological Markers to Improve Clinical Care in Autism” on Tuesday, February 13, 2024, at 2:00 pm ET. The presenter will be James McPartland, Ph.D.,

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Drug Target Review

AUGUST 28, 2024

This is reflected in the MATCH data recently presented at the European Association for the Study of the Liver (EASL), where two patients in the control group had a liver transplant and seven patients died, whereas there were no liver transplants and only two deaths in the treated group. Reference 1 Brennan P et al.,

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KIF1A

SEPTEMBER 30, 2023

This program will encourage therapeutic sponsors to communicate with FDA officials more regularly and as needed to improve their clinical development of gene- and cell-based therapies. What’s a pre-print? Check out this #ScienceSaturday post to learn more.

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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 observation may be important given the critical role of DC in tumor antigen presentation.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J. His remarks are worth reading in their entirety.

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Drug Target Review

APRIL 3, 2024

Our research demonstrated that GDF-15 acts as a versatile tool for tumours to inhibit the mounting of an effective antitumoral immune response at various steps of its process, including antigen presentation, immune cell activation, and their migration and infiltration into the tumour.

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Drug Target Review

JANUARY 8, 2024

Jerry has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development, and global commercialisation of more than a dozen FDA-approved drugs with multiple successful exits. What’s next for Life Bioscience’s preclinical studies?

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LifeSciVC

APRIL 2, 2024

The science presents an opportunity and a challenge for us at Sionna. The insights from these internal discussions refined our messaging and helped demonstrate the compelling opportunity we have to advance a truly groundbreaking clinical development program.

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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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FDA Law Blog: Biosimilars

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers. An earlier FDA guidance, revised in 2021.

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