The Pharma Data

NOVEMBER 8, 2021

Bristol Myers Squibb moment blazoned the Phase 3 CheckMate-816 trial met the primary endpoint of bettered event-free survival (EFS) in cases with resectable stage IB to IIIAnon-small cell lung cancer (NSCLC). vice chairman, thoracic cancers development lead, Bristol Myers Squibb. “ About Lung Cancer.

Trials 52

Trials Clinical Trials Treatment Clinical Development 52

The Pharma Data

JUNE 30, 2021

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. This press release features multimedia.

Therapies 52

Therapies Treatment Virus Vaccine 52

Alta Sciences

AUGUST 18, 2023

Don’t miss out: [link] Event End Date Thu, 10/26/2023 - 12:00 Event Start Date Thu, 10/26/2023 - 12:00 Weight 1

Drug Development 40

Drug Development Compliance Clinical Development FDA 40

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

The Open Targets Blog

JUNE 26, 2023

Gene essentiality Core essential genes are unlikely to tolerate inhibition, and are therefore susceptible to cause adverse events if modulated. This is crucial safety information for drug discovery scientists looking to develop inhibition strategies. Users can view a specific list of adverse events, mapped to EFO terms.

Disease 59

Disease Clinical Development Clinical Trials Drugs 59

The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024. CEST / 8 a.m.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

Clinical Development 52

Clinical Development Therapies Disease Research 52

The Pharma Data

APRIL 24, 2023

“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

FDA 40

FDA Clinical Development Trials Treatment 40

The Pharma Data

JUNE 7, 2023

Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 31% of patients receiving doublet therapy and 58% of patients receiving triplet therapy. Across treatment cohorts, there were 27 interstitial lung disease (ILD) or pneumonitis events adjudicated as drug-related by an independent committee.

Trials 40

Trials Protein Expression Therapies Treatment 40

The Pharma Data

OCTOBER 26, 2020

Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. The conference ID number for the call is 8557525.

Clinical Trials 52

Clinical Trials Clinical Development Trials Engineering 52

Conversations in Drug Development Trends

APRIL 5, 2024

Each day throughout the month of February, we heard what was on the minds and hearts of patients and patient advocacy organizations, clinical developers driving treatments, and family members supporting people with rare diseases. We were overwhelmed by how excited the community was to participate!

Disease 52

Disease Clinical Trials Trials Treatment 52

Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? Also known as a clinical event committee (CEC), EAC members evaluate a clinical event in the context of the protocol and the individual participant’s medical information.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

The Pharma Data

APRIL 28, 2022

In the trial, there was no statistical difference in estimated hypoglycaemia rates, and no severe hypoglycaemia events were observed for people treated with insulin icodec. The rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) were 0.73 events per patient-year exposed to insulin degludec.

Trials 52

Trials Clinical Trials Treatment Clinical Development 52

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. The company expects to share further details in early 2021.

Pharmaceuticals 40

Pharmaceuticals Cell Based Assays Clinical Development Treatment 40

The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

Disease 52

Disease FDA FDA Approval Treatment 52

Advarra

APRIL 4, 2024

Moreover, familiarity with the drug and its development process allows DSMB members to detect subtle changes or trends in safety data over time. Faster Setup Establishing a new DSMB can take months for member identification, charter development, technology system setup, and other setup activities.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials FDA 52

The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement. Source link.

FDA 52

FDA Pharmaceuticals Small Molecule Clinical Development 52

The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. ” About Ascentage Pharma.

Clinical Development 52

Clinical Development FDA Regulations Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec. Contact: Tauriga Sciences, Inc.

Science 52

Science Pharmaceuticals Clinical Development Production 52

The Pharma Data

FEBRUARY 13, 2022

Asundexian is currently in Phase II clinical trials in all three indications either as a standalone therapy, or in combination with anti-platelet therapy. Inhibition of FXIa by asundexian is hypothesized to provide protection from thrombotic events without increasing the risk of bleeding.

FDA 40

FDA Clinical Trials Trials Therapies 40

Drug Target Review

JANUARY 15, 2024

Gaining access inside cells Fortunately, evolution has provided a mechanism, found in all higher vertebrates, for the immune system to monitor intracellular events. Previously, as a member of the faculty at Harvard Medical School , Dr Kavanagh was engaged in preclinical and clinical development of cellular immunotherapy and products.

Engineering 110

Engineering DNA Virus Immune Response 110

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. Upcoming E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

The Pharma Data

MARCH 18, 2021

The most common adverse events were gastrointestinal. Across all groups, 5–14% of people discontinued any trial treatment due to adverse events. The study met its primary endpoint, demonstrating that all regimens were well tolerated over 24 weeks.

Treatment 52

Treatment FDA Science Disease 52

The Pharma Data

JANUARY 7, 2021

a clinical-stage biopharmaceutical company, today announced that Xiaodong Yang , M.D., President and Chief Executive Officer, will participate in two upcoming virtual investor healthcare conferences: The Solebury Trout Virtual Management Access Event being held January 6 – 15, 2021. SAN CARLOS, Calif. , About Apexigen.

Clinical Development 40

Clinical Development International Production Drugs 40

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

The Pharma Data

APRIL 1, 2021

Among the patients who died after receiving Tecartus, one had a fatal CRS event. Serious events associated with CRS included hypotension, fever, hypoxia, acute kidney injury, and tachycardia. In ZUMA-2, neurologic events occurred in 81% of patients, 37% of whom experienced Grade ?3 Grade 3 CRS in 18% of patients.

Treatment 52

Treatment Virus Therapies FDA 52

Drug Target Review

AUGUST 24, 2023

Infiltration of immune cells into tissues follows a cascade of events, namely rolling, activation, adhesion and transmigration, which are mediated by different molecules. How does GDF-15 impact the tumour microenvironment and the infiltration of T cells into the tumour?

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

JANUARY 14, 2021

The incidence of all grade adverse events was similar in the bemarituzumab and placebo arms of the study (100% vs 98.7%, respectively). Corneal events were reported more frequently in the bemarituzumab arm (67.1% Grade 3 and higher adverse events (82.9% vs 74.0%), serious adverse events (31.6%

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

NOVEMBER 11, 2021

The VICTOR study will explore the efficacity of vericiguat in habitual heart failure cases and reduced ejection bit of 40 percent or lower who haven’t had a recent worsening HF event, a population similar to those of several other recent heart failure studies. Grounded on the VICTORIA study, vericiguat was lately approved in theU.S.,

Treatment 40

Treatment Production Clinical Development Hospitals 40

The Pharma Data

OCTOBER 28, 2020

Interested participants may register for the event free of charge here. A further signal of benefit was provided by analysis of treating physicians’ Clinical Global Impression of Change in a subpopulation of patients with more advanced disease progression. About Vaccinex, Inc. Vaccinex, Inc.

Clinical Trials 40

Clinical Trials Treatment Clinical Development Disease 40

The Pharma Data

SEPTEMBER 6, 2021

In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. These results will guide us to advance our clinical development strategy of eliapixant.”.

Trials 52

Trials Clinical Trials International Treatment 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna. View source version on businesswire.com: [link].

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 52

The Pharma Data

JANUARY 20, 2021

The CEC comprises clinical experts in cardiology and Intensive Care and has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events. In order to ensure an unbiased endpoint assessment, members of the CEC are blinded to treatment assignment. About Cardiol Therapeutics.

Hospitals 52

Hospitals Trials International Clinical Trials 52

The Pharma Data

MAY 27, 2022

Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS. Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events.¹.

Treatment 52

Treatment Therapies Clinical Trials Disease 52

The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

Clinical Trials 52

Clinical Trials Trials Therapies Production 52

The Pharma Data

AUGUST 30, 2021

A kidney outcome event occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo. Despite current treatment options, patients remain at high risk of progression to kidney failure and cardiovascular events,” said Professor Gerasimos Filippatos, M.D., The majority of adverse events were mild or moderate.

Disease 52

Disease Clinical Trials Hospitals Therapies 52