Drug Discovery World

JANUARY 6, 2023

ISA103 was developed using the company’s Synthetic Long Peptide (SLP) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein. . A total of 90 patients will be enrolled in the trial. .

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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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. Disclaimer.

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Drug Discovery World

JULY 21, 2023

Analysts Phesi revealed that a third of clinical development programmes are cancelled during Phase II, and there were significant trial results for drugs for head and neck cancer and Alzheimer’s disease. The most impactful drug discovery news this week is all linked with scientific research data.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is administered through intravenous drip route.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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pharmaphorum

MARCH 29, 2022

Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after BIIB078 (IONIS-C9Rx) failed to demonstrate clinical benefit in a Phase 1 trial. This is the latest in a string of setbacks for both companies in recent months.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. By combining chemotherapy with immunotherapy strategies, the company aims to develop new solutions for cancer patients.

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Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Clinical holds are becoming more common, especially in gene therapy programs.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. All key questions to consider and address before the therapy even leaves the lab.

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Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

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Drug Discovery World

JANUARY 19, 2023

A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint. million related deaths globally. “The trial shows promising positive results across a variety of primary and secondary endpoints.

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The Pharma Data

JANUARY 3, 2021

. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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The Pharma Data

JANUARY 10, 2021

Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements. SINGAPORE, Jan. Forward looking statements.

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The Pharma Data

JANUARY 10, 2021

IDE397 is being developed as a potential best-in-class MAT2A inhibitor for MTAP-deletion, which is prevalent in approximately 15% of all solid tumors. Morgan Healthcare Conference, including preclinical data showing tumor regressions in MTAP-deleted PDX models and proposed Phase 1 clinical plan.

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WCG Clinical

JULY 12, 2023

The report provides a 360-degree review of what motivates or deters potential volunteers from participating in clinical trials, and what steps can be taken to encourage more participation, particularly among underrepresented groups. Avoca joined the WCG family of companies in April 2021.

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The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. President and CEO of Knopp. “We study centers.

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG. About the RAISE Trial. RADNOR, Pa.–(

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

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pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. SINGAPORE, Oct. SINGAPORE, Oct. The company expects to share further details in early 2021.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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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. About SQI Diagnostics. SQI Diagnostics, Inc.

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The Pharma Data

JANUARY 13, 2021

NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. SOUTH SAN FRANCISCO, Calif.,

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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. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D.,

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pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

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The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

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The Pharma Data

OCTOBER 26, 2020

Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Synlogic anticipates that subsequent events and developments will cause its views to change.

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