Clinical Development, Clinical Research, Containment and Development

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

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

Food and Drug Administration (FDA) has cleared the initiation of the safety phase of the Company’s EDIT-301 clinical trial, and the Company can begin dosing patients. The Company is required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial.

Medicine

Medicine Development Clinical Trials Clinical 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

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. 5,6 The program was granted Fast Track designation by the U.S. FDA in July 2017.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

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

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Research and development efforts will be led by Dr. Paul Van Slyke. . – January 25, 2021) – PharmaDrug Inc.

Drugs

Drugs Containment Development Sales

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

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Development

Development Protein Manufacturing Medicine

Galecto Appoints Anne Prener to its Board of Directors

The Pharma Data

JANUARY 7, 2021

NASDAQ: GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors. “We Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta.

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. The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells.

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. He has developed new diagnostic tests for Alzheimer’s disease, as well as new preclinical models. About NervGen.

Clinical Development

Clinical Development Containment Development Research

Patient centricity and the changing pharmaceutical vista

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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

The Pharma Data

DECEMBER 14, 2020

NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc.

Clinical Trials

Clinical Trials Clinical Trials Clinical Development Antibody

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

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

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. About mRNA-1273.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

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

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

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’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. 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

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

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. head of Immunology and Fibrosis Development, Bristol Myers Squibb. Presentation Topic: Clinical Trials. Author: Selmaj.

Trials

Trials Clinical Trials Clinical Trials Vaccination

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

The Pharma Data

JUNE 26, 2021

Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. About EXPLORER The EXPLORER clinical research program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition.

Doctors

Doctors Doctor Medicine Clinical Trials

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

pharmaphorum

MAY 25, 2021

A recent pharmaphorum webinar , held in partnership with Savana and BREATHE – the Health Data Research Hub for Respiratory Health, heard that RWE is also accelerating the development of new and innovative therapies and treatments to improve patient outcomes. The benefits of RWE.

Big Data

Big Data Clinical Research Research Trials

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. The company is also in collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral treatment for COVID-19.

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.

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

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

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

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

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

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

Patient centricity and the changing pharmaceutical vista

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

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

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

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

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

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

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

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

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

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

COVID-19 Pandemic Coverage

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