Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” The post Trends in Oncology Study Design, from Optimus to Endpoints appeared first on Worldwide Clinical Trials.

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Drug Target Review

JUNE 6, 2023

However, the protein’s preclinical promise has not yet been replicated in clinical trials, where systemic administration is associated with dose-limiting toxicities and a narrow therapeutic index. Some approaches have already reached the clinical trial stage, with others not far behind.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. . In clinical studies, PRX-102 has been observed to have a circulatory half-life of approximately 80 hours.

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Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Read the fact sheet. Watch it now.

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Alta Sciences

JUNE 9, 2023

Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money. Speak with an expert today to discuss your next clinical program.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 This means study startup times can vary greatly.

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PPD

MAY 11, 2023

The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when. The Many Considerations of Pediatric Vaccine Clinical Trials Childhood vaccines are highly effective in the prevention of many diseases.

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The Pharma Data

MARCH 5, 2021

We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021.” About the BRUIN Phase 1/2 Trial. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e.

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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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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

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The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

OCTOBER 27, 2020

Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. Primmune aims to advance the development of their novel orally-administered, small molecule toll-like receptor 7 agonists as therapeutic-adjuvants for acute viral diseases and cancer. million in 2015.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s).

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The Pharma Data

NOVEMBER 4, 2020

Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors.

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The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The study will be conducted in South Africa. President and Chief Executive Officer of SCYNEXIS. For more information, visit www.scynexis.com. Forward Looking Statement.

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The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

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The Pharma Data

OCTOBER 18, 2020

The 450mg starting dose in AML patients was selected because that dose, when administered to CLL patients being treated in a separate Phase 1 a/b trial, appeared safe, well tolerated and achieved plasma exposure levels that effectively inhibited phospho-FLT3 activity, which is a key driver of AML.”. Forward Looking Statements.

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The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. 8] , [9] , [10] , [11] , [12]. 8] , [9] , [10] , [11] , [12]. **In

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Alta Sciences

APRIL 17, 2024

Our experts align the appropriate bioanalytical approach with the goals of the oligonucleotide drug development program, based on its size/type, the sensitivity and specificity required, as well as throughput needed based on the preclinical or clinical phase of the drug in development. Asia, and Europe.

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Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Both trials showed no difference between phenylephrine and placebo.

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The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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The Pharma Data

APRIL 11, 2021

The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor. The trial, which spans 16 countries and 89 sites, included a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). Retevmo (marketed as Retsevmo ® outside the U.S.)

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The Pharma Data

DECEMBER 13, 2020

The primary endpoint of the trial will be NASH resolution with no worsening of fibrosis assessed on histology. The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability.

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PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. Participant fatigue in GLP-1 clinical trials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.

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The Pharma Data

JULY 21, 2021

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for once-daily treatment. Our Commitment to HIV.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. 1. -- -->. -- [if lte IE 8]--> .

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