The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

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The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

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Drug Patent Watch

DECEMBER 10, 2024

The typical cost of developing a biosimilar ranges from $100 million to $300 million, with clinical trials accounting for more than half of the budget. Additionally, the production process must be optimized to minimize variability and ensure consistency across different batches. Another significant challenge is the high cost of development.

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The Pharma Data

JANUARY 6, 2021

The REVIVAL Phase III pivotal trial is a randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI. Seminars in Nephrology, 2015; 35(1): 2-11. pharma.com.

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Drug Target Review

OCTOBER 26, 2023

Subsequent roles at the Institute of Cancer Research and The Scripps Research Institute solidified his expertise in protein design and vaccine development, leading to the 2015 Scripps CHAVI-ID Young Investigator Award. Nature Communications 6 , 6246 (2015). Russell S, et al. The Lancet 390 , 849-860 (2017). Wang D, Tai PW, Gao G.

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Drug Target Review

NOVEMBER 6, 2023

Throughout his career, he has published more than 300 papers in peer-reviewed journals, served as the principal investigator of more than 60 clinical trials and led two independent National Cancer Institute–funded Specialized Programs of Research Excellence at MDACC and MSKCC. 2015);126(1):9-16. 2015);126(4):454-462.

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The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. 2015; Chevallier et al. . SOUTH PLAINFIELD, N.J. ,

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DrugBank

AUGUST 15, 2024

This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks. Their established infrastructure, including access to patient populations and clinical trial sites, can significantly accelerate the development timeline.

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The Pharma Data

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P, BARCELONA, Spain , Jan.

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The Pharma Data

SEPTEMBER 29, 2020

. Sosei Heptares has received a $5m milestone payment from its strategic alliance partner Pfizer after the first subject in a clinical trial was dosed with a new drug candidate from the collaboration between the two companies. At the time, Pfizer made a $33m equity investment in Sosei as part of the collaboration agreement.

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Drug Target Review

AUGUST 17, 2023

As a result of this study a Phase I clinical trial sponsored by BioInvent International is currently underway (ClinicalTrials.gov ID: NCT05555251), which aims to investigate the efficacy of an engineered Fc-null anti-FcγRIIB (clone BI-1607) in combination with Transtuzumab (anti-HER2) in HER2-positive advanced solid tumours. Immunol Rev.

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The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2024

The Breakthrough program started in 2015. Even for higher-prevalence conditions, CDRH’s recent feedback in pre-submission meetings shows just how far apart the review teams are from the reality of what it takes to run a robust clinical trial. The reality, however, is quite different.

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The Pharma Data

OCTOBER 22, 2020

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate. “W Additional details on the INTERLINK-1 clinical trial can be found here. . MARSEILLE, France, Oct. The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. 2015 Sep 29;6:8382. 2015 Nov 19;163(5):1204-1213. Epub 2015 Nov 12. Sci Transl Med. 2017 Mar 29;9(383):eaag1166. medRxiv; 2023. Nat Commun.

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The Pharma Data

AUGUST 8, 2020

With its latest trial win, Eli Lilly and its Chinese partner Innovent Biologics are eyeing an all-important front-line non-small cell lung cancer approval in China for their PD-1 checkpoint inhibitor, Tyvyt. In November, Keytruda nabbed its chemo combo squamous go-ahead in China based on data from the phase 3 Keynote-407 trial.

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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The Pharma Data

AUGUST 5, 2020

Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015 8. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. December 21, 2015. Hauser S, Bar-Or A, Cohen J, et al.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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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. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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LifeSciVC

JULY 11, 2023

The meeting brings together tens of thousands of physicians, scientists, patients, advocates, innovators, and those involved in oncology drug development from around the world in order to explore the latest advances in cancer treatment, clinical trials, and translational and clinical research.

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The Pharma Data

SEPTEMBER 28, 2020

This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Nucala was first approved in 2015 to treat severe eosinophilic asthma as an add-on maintenance therapy for the condition, and for the treatment of eosinophilic granulomatosis with polyangiitis.

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The Pharma Data

JANUARY 6, 2021

ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021.

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Broad Institute

MAY 9, 2024

Initially announced in March 2015, this renewed agreement extends the collaboration until September 2029 and will continue to support ongoing programs focused on the biology and genetics of aging as well as early-stage drug discovery.

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The Pharma Data

MARCH 13, 2021

“Tau has become increasingly validated as a predictive biomarker for Alzheimer’s disease progression, as shown again in this trial,” said Liana G. Patients with treatment discontinuations were allowed to continue in the trial. In the US alone, there was an increase of 8 million new caregivers from 2015 to 2020 5.

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Drug Target Review

SEPTEMBER 21, 2023

Debrah, AY et al (2015) ‘Doxycycline Leads to Sterility and Enhanced Killing of Female Onchocerca volvulus Worms in an Area with Persistent Microfilaridermia after Repeated Ivermectin Treatment: A Randomized, Placebo-Controlled, Double-Blind Trial’, Clinical Infectious Diseases, 61(4), pp. Awadzi, K et al. doi: 10.1093/cid/civ363.

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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Drug Target Review

SEPTEMBER 6, 2024

VIVEbiotech is involved in the manufacture of more than 50 different LVVs since 2015, eight of these programmes being for in vivo applications. Finally, the market demand has increased as clinical trials are advancing towards more advanced phases and more vectors are being approved for commercial use.

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Drug Target Review

OCTOBER 17, 2024

The broad regulatory function of this pathway suggests that we do not need to limit our clinical strategy until more information is gathered in the FIH trials. The results from such trials would inform whether and how future combination trials should be designed. Biomarkers are the holy grail of clinical trials.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 18] In February 2015, Cerecor Inc. 18] In February 2015, Cerecor Inc. 11 December 2015.

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The Pharma Data

JANUARY 11, 2021

MediciNova intends to use the proceeds received from the private placement primarily for the following three programs: 1) To initiate a new clinical trial of MN-166 (ibudilast) for glioblastoma, which could be a pivotal trial. 3) To initiate a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).

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The Pharma Data

AUGUST 12, 2020

The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. Clinical trial diversity needs acceleration. The company achieved gender parity across its workforce in 2015. geographies.

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The Pharma Data

MARCH 27, 2021

The CHMP opinion is based on the results of a phase 3 trial published last year in the New England Journal of Medicine, which demonstrated a significant reduction in Body Mass Index (BMI) Standard Deviation Score (SDS), and reduction in BMI, body weight and other weight? About the phase 3 trial (NCT02918279).

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The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

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The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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