The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec.

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The Pharma Data

MARCH 25, 2021

Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., However, this observational analysis differs from the randomized clinical trial in several ways. Since the initial approval by the U.S.

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DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage. While challenges persist, the weight loss drug boom shows no signs of waning.

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

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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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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. ” About Hepion Pharmaceuticals.

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Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. cell and gene therapies), with other therapeutic areas then pushing it further. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

MARCH 5, 2021

” In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL. About the BRUIN Phase 1/2 Trial. The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase.

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New Drug Approvals

DECEMBER 24, 2023

“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z. PMC 9837340. PMID 36525140. Coelho, Teresa; Marques, Wilson; Dasgupta, Noel R.; PMC 10540057.

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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. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

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Drug Target Review

OCTOBER 24, 2023

Could you elaborate on the drug being developed by Microbiotica to stimulate cancer patients to respond favourably to immune checkpoint inhibitor therapy? It is likely the combination of these mechanisms of action that will make MB310 an effective therapeutic. How does it work and what are the potential benefits?

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The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies. But metastatic breast cancer is still an unmet need.

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The Pharma Data

JANUARY 3, 2021

Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. The pharmacokinetics of nasally administered Foralumab will also be evaluated.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)? with antibodies), or correction (e.g., in the case of CFTR for Trikafta).

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The Pharma Data

MARCH 23, 2021

We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

MARCH 22, 2021

GENERATION HD1 is the largest clinical trial in Huntington’s disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. About tominersen and the clinical trials. said Levi Garraway, M.D., About Roche in Neuroscience.

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The Pharma Data

NOVEMBER 26, 2020

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. Galactosidase-A enzyme.

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The Pharma Data

JANUARY 19, 2021

This small molecule therapy is presently in Phase 1 clinical trial for mild to moderate Alzheimer’s disease (AD), which is supported by a NIA R01 grant in healthy aged volunteers. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , There is a great need for a disease-modifying treatment for the 5.3

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The Pharma Data

NOVEMBER 5, 2020

As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.

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The Pharma Data

MARCH 9, 2022

PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a pediatric clinical study PAXLOVID is currently authorized under U.S. The safety and effectiveness of PAXLOVID have not yet been directly established in pediatric patients.

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The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

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The Pharma Data

DECEMBER 15, 2020

Daratumumab induced substantial clinical responses in the patients. The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors. Receptor Inhibitors.

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Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s We are proud to support Ischemix in advancing this vital new therapy.”

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The Pharma Data

OCTOBER 27, 2020

“Once we’re in the clinic, we will continue to add multiple programs into the clinic with no rate abatement, or speed abatement, in the next five- to 10-year horizon.” . Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio . Sirnaomics.

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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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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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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

DECEMBER 27, 2020

Phase I Trial. phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. This trial also investigates the food effect on ASC42 exposure.

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The Anticancer Fund

APRIL 1, 2022

Top story Inflammatory fibroblasts mediate resistance to neoadjuvant therapy in rectal cancer Published in Cancer Cells Inflammatory cancer-associated fibroblasts (iCAFs) are associated with poor chemoradiotherapy response in rectal cancer. A small phase I clinical trial (NCT04942626) is testing this hypothesis in rectal cancer patients.

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Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence. Once the IS has been selected, a quantitation range can be set using reference solutions.

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The Pharma Data

JANUARY 26, 2021

percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. who require oxygen therapy due to COVID-19, OR.

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The Pharma Data

JULY 23, 2021

This approval is based on results from a multicenter, open-label, actively controlled clinical trial evaluating DALVANCE in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies. This analysis evaluated an early clinical response at 48 to 72 hours based on achieving a ?

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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.”. About CG-806.

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The Pharma Data

NOVEMBER 9, 2021

The company has transformed the trajectory of many liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

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