The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial , which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. About the Phase 1/2 Trial. Lauren Padovan.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. is a leading global pharmaceutical company headquartered in Japan. About Alzheimer’s Disease. About Eisai Co.,

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. The International Consortium for Innovation and Quality in Pharmaceutical Development has published guidelines to qualify as a valid model for specific organ-chip applications. The US FDA Modernisation Act 2.0.,

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The Pharma Data

SEPTEMBER 1, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. The safety profile observed in the trial was consistent with previous studies of INVEGA SUSTENNA ® and INVEGA TRINZA ® with no new safety signals emerging. About the Clinical Trial. Results found that 92.5

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The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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Drug Discovery World

AUGUST 8, 2022

DDW Editor Reece Armstrong speaks to Stephanie Seremetis, Chief Medical Officer, Rare Blood Disorders at Novo Nordisk to get her response to the company’s latest study results for its Mim8 antibody. SS: In FRONTIER1, phase I and phase II was combined into a single clinical trial, thereby expediting the study time.

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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

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About ALS-4. About Aptorum Group.

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *© All rights reserved.

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The Pharma Data

JANUARY 17, 2021

Spero has previously reported data from a Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for targeting MDR Gram-negative bacterial infections. SHANGHAI , Jan.

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). TITUSVILLE, N.J. , Global Head, Janssen Research & Development, Johnson & Johnson.

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The Pharma Data

NOVEMBER 22, 2020

. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” About Molecular Partners’ anti-COVID-19 program.

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The Pharma Data

OCTOBER 27, 2020

The growth in Orenitram revenues resulted primarily from an increase in quantities sold, as the number of patients being treated with Orenitram grew following the update to Orenitram’s labeling to reflect the FREEDOM-EV clinical trial results, partially offset by the impact of the Excess Order. NON-GAAP FINANCIAL INFORMATION.

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Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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The Pharma Data

JUNE 28, 2021

“The filing of this application in the US is an important step in helping to address the burden of venous thromboembolism and provide doctors with body weight-based dosing options in pediatric patients,” said Dr Christian Rommel, Head of Research and Development and Member of the Executive Committee at Bayer Pharmaceuticals. EINSTEIN-Jr.

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Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. These information retrieval capabilities have many applications, from writing computer code and collating clinical trial results to summarizing papers on a specific topic.

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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. 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. Galactosidase-A enzyme.

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The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score.

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