Conversations in Drug Development Trends

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

Clinical Trials 52

Clinical Trials Trials Clinical Development Drug Development 52

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. How do they stack up? Other therapeutic areas include cell and gene therapy.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Drug Target Review

JANUARY 8, 2024

With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK. We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation.

Science 145

Science Disease FDA Approval Clinical Trials 145

The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs.

Clinical Development 40

Clinical Development Disease Clinical Trials Therapies 40

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

thought leadership

JUNE 27, 2023

In recent years, Australia has emerged as a leading destination for conducting clinical trials , attracting pharmaceutical, biotech, medical device/diagnostic companies, and research organizations globally.

Clinical Trials 40

Clinical Trials Trials Clinical Development Pharmaceuticals 40

Broad Institute

NOVEMBER 2, 2023

Our joint goal is to bring innovation to cancer patients by building a robust, sustainable pipeline in oncology,” said Dominik Ruettinger, Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG.

Therapies 105

Therapies Research Small Molecule Clinical Trials 105

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

Disease 81

Disease Clinical Trials Trials Pharmaceutical Companies 81

The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link].

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

The Pharma Data

DECEMBER 1, 2020

01, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. About Allena Pharmaceuticals Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Clinical Development 52

The Pharma Data

MARCH 15, 2021

This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Local authorities, such as the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the U.S. We are committed to Good Clinical Practice. Neuroscience.

Clinical Trials 40

Clinical Trials Trials Clinical Development Clinical Research 40

The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . About CNS Pharmaceuticals, Inc.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

The Pharma Data

DECEMBER 21, 2020

The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

Vaccine 52

Vaccine Trials Clinical Trials Clinical Development 52

The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. HENDERSON, Nev.–(

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

The Pharma Data

DECEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “We About Lexicon Pharmaceuticals. THE WOODLANDS, Texas, Dec. Safe Harbor Statement.

FDA 52

FDA Pharmaceuticals Small Molecule Clinical Development 52

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). To address dose limiting toxicities seen at higher doses earlier in the trial, a new safety protocol was implemented, enabling higher doses to be administered. ROCKVILLE, Md. , and BEIJING , Jan. Nasdaq: CASI), a U.S.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

SEPTEMBER 6, 2021

The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”.

Trials 52

Trials Clinical Trials Treatment International 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

Hospitals 52

Hospitals Trials International Clinical Trials 52

The Pharma Data

JANUARY 3, 2021

03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK),

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Licensing Licensing 52

The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

Drug Development 73

Drug Development Clinical Trials Drugs Therapies 73

Conversations in Drug Development Trends

APRIL 15, 2024

Worldwide Clinical Trials recently conducted a comprehensive research study, where we included 140 key industry-decision makers from biotech and pharmaceutical companies of all sizes. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide Clinical Trials.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. (Alume) announced today that it has been awarded a $2.5M About Alume Biosciences, Inc.

Clinical Trials 52

Clinical Trials Trials Clinical Development Pharmaceuticals 52

Advarra

APRIL 4, 2024

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials FDA 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. SOURCE: Eloxx Pharmaceuticals, Inc. WALTHAM, Mass., Conference ID : 9467336. Source link.

Pharmaceuticals 52

Pharmaceuticals RNA Small Molecule Protein Production 52

Drug Target Review

FEBRUARY 1, 2024

Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinical trials. We were able to license a molecule from a multi-national pharmaceutical company.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. –( BUSINESS WIRE )– Marinus Pharmaceuticals, Inc. About the RAISE Trial. About Marinus Pharmaceuticals. Marinus Pharmaceuticals, Inc. Marinus and Ceribell, Inc. RADNOR, Pa.–(

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. NEW YORK , Jan.

Clinical Trials 52

Clinical Trials FDA Trials Production 52

Drug Target Review

OCTOBER 11, 2023

Symptoms were reversed in mouse models and a clinical trial is planned for later this year. 5 This drug candidate is progressing towards the clinic, with phase 1 trials due to start within 18 months. This restores movement and improves nerve condition, which should bring back sensation.

Disease 113

Disease Treatment Small Molecule Therapies 113