2018, Clinical Development and Clinical Research

2018

Clinical Development

Clinical Research

How to Optimize Drug Development by Combining FSO and FSP Models

PPD

SEPTEMBER 6, 2023

In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Examples of Hybrid Outsourcing Strategies for Clinical Trials For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use.

Drug Development

Drug Development Clinical Trials Drugs Clinical Research

UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

The Pharma Data

JANUARY 6, 2021

“Further, PDE4-inhibition is a well-documented pharmacological target for a number of other inflammatory indications, and we look forward to advancing our clinical research to realize the full potential of orismilast for the benefit of the millions of patients living with inflammatory conditions globally,” adds Professor Sommer.

FDA Approval

FDA Approval FDA Clinical Development Clinical Research

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Trending Sources

Chemical Biology and Drug Design

Pfizer CMO Steps Down, Stanford Professor to Transition into Role

The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products.

Pharma Companies

Pharma Companies Clinical Development Clinical Research International

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. 2018 Mar;17(3):167–81.

Drugs

Drugs FDA Disease Animal Testing

Syneos Health Appoints Michael Bonello as Chief Financial Officer

The Pharma Data

MAY 2, 2023

Bonello has more than 30 years of financial leadership experience, including 15 years in the clinical research industry. a clinical trial data collection company, since 2021. a clinical trial data collection company, from November 2021 to present. a clinical trial data collection company, since 2021.

Clinical Trials

Clinical Trials Clinical Research Science Clinical Development

Tackling Hepatitis B in the Asia-Pacific Region

PPD

OCTOBER 24, 2024

Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection. Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.

Vaccine

Vaccine Virus Treatment Disease

BioSpace Movers & Shakers, Dec. 18

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

Small Molecule

Small Molecule Engineering Clinical Development Pharmaceuticals

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.

FDA

FDA Drugs Clinical Development Disease

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 Treatment Therapies Clinical Trials

Meet the Patient Advocate Panelists in Our Upcoming Webinar: Rare Disease Day 2023 Wrapped, What You Need to Take Away

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. Rob: UA first began donating funds to researchers through our annual event, the Young Investigator’s Draft, in 2018. So, I decided to pivot.

Disease

Disease Clinical Trials Trials Treatment

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

Grand View Research August 2018 ( [link] ). About Tiziana Life Sciences Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. NEW YORK and LONDON, Nov. Cited References: 1. da Cunha, A. and Weiner, H.

Clinical Trials

Clinical Trials Science Disease Trials

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

FDA Production Regulations Vaccine

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 Treatment Hospitals 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 International Production

Drug Discovery Digest

How to Optimize Drug Development by Combining FSO and FSP Models

UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

Trending Sources

Pfizer CMO Steps Down, Stanford Professor to Transition into Role

Human neuronal cells: possibilities in drug safety testing

Syneos Health Appoints Michael Bonello as Chief Financial Officer

Tackling Hepatitis B in the Asia-Pacific Region

BioSpace Movers & Shakers, Dec. 18

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

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

Meet the Patient Advocate Panelists in Our Upcoming Webinar: Rare Disease Day 2023 Wrapped, What You Need to Take Away

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

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

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

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

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