Clinical Development, Clinical Research and Containment

WCG Publishes Report Providing Assessment of Motivators Across All Clinical Research Stakeholders

WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Alliance Pharma expands into Australia

Drug Discovery World

AUGUST 22, 2022

The new 20,000 square foot purpose-built facility will contain an expansive state-of-the-art lab, providing small and large molecule bioanalytical services for the Brisbane region. . Official comments . The post Alliance Pharma expands into Australia appeared first on Drug Discovery World (DDW).

Containment

Containment Clinical Development Clinical Research Marketing

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

FDA Approval

FDA Approval Containment Clinical Development Trials

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

Drugs

Drugs Containment Development Sales

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Galecto Appoints Anne Prener to its Board of Directors

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Gene Therapy

Gene Therapy Life Science Production Clinical Development

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. This vision is what defines us and guides our research, clinical development and partnerships. Wainberg, M.D., Wainberg, M.D.,

Trials

Trials HR Containment Development

NervGen Pharma Establishes Alzheimer’s Disease Scientific Advisory Board

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. All clinical development plans are subject to additional funding. ” “I am excited about the potential of NVG-291,” stated Dr. .”

Clinical Development

Clinical Development Containment Development Research

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

The Pharma Data

DECEMBER 14, 2020

Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis.

Clinical Trials

Clinical Trials Clinical Trials Clinical Development Antibody

Patient centricity and the changing pharmaceutical vista

pharmaphorum

JANUARY 27, 2023

Minimising any of those delays that happen throughout the clinical trial, or the clinical development is really important and, more and more, it’s about having experts involved in providing advice in that clinical development and clinical trial programme [that] is really important.”

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering – Oct 23, 2020

The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

In-Vitro

In-Vitro Clinical Trials Clinical Trials Sales

Tiziana Life Sciences announces collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn’s Disease

The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Life Science

Life Science Clinical Trials Clinical Trials Trials

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program.

Trials

Trials Clinical Trials Clinical Trials Vaccination

AI, big data and real world evidence – the challenges and opportunities

pharmaphorum

MAY 25, 2021

Opportunities are growing for real-world evidence research as the technology matures and a pioneering new partnership between Savana, utilising its AI-driven clinical research methodology, and BREATHE aims to drive innovative research using this new way of working. The benefits of RWE. About BREATHE.

Big Data

Big Data Clinical Research Research Trials

Editas Medicine Announces the FDA has Cleared Initiation of the EDIT-301 Clinical TrialEDIT-301 is in development as a best-in-class, durable medicine for people living with sickle cell disease

The Pharma Data

JANUARY 10, 2021

Editas Medicine is preparing to initiate the RUBY clinical trial, a Phase 1/2 trial designed to assess the safety and efficacy of EDIT-301 for the treatment of sickle cell disease. The Company has identified a lead principal investigator and engaged a Clinical Research Organization (CRO).

Medicine

Medicine Development Clinical Trials Clinical Trials

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

HR

HR FDA Approval Containment Genome

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

The Pharma Data

JUNE 26, 2021

Part of the industry leading EXPLORER clinical research program, EINSTEIN-Jr is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and UNIVERSE is the first clinical trial to examine a DOAC for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.

Doctors

Doctors Doctor Medicine Clinical Trials

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. Department of Defense Contract No.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

The Pharma Data

OCTOBER 27, 2020

Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423 and Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials.

Development

Development Protein Manufacturing Medicine

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

FDA Approval

FDA Approval Containment Hormones Dermatology

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

Trials

Trials Clinical Trials Clinical Trials Production

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months.

Vaccination

Vaccination Vaccine Antibody Life Science

Clinical Research Informer

WCG Publishes Report Providing Assessment of Motivators Across All Clinical Research Stakeholders

Alliance Pharma expands into Australia

Trending Sources

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Galecto Appoints Anne Prener to its Board of Directors

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

NervGen Pharma Establishes Alzheimer’s Disease Scientific Advisory Board

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

Patient centricity and the changing pharmaceutical vista

Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering – Oct 23, 2020

Tiziana Life Sciences announces collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn’s Disease

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

AI, big data and real world evidence – the challenges and opportunities

Editas Medicine Announces the FDA has Cleared Initiation of the EDIT-301 Clinical TrialEDIT-301 is in development as a best-in-class, durable medicine for people living with sickle cell disease

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

COVID-19 Pandemic Coverage

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