Drug Discovery World

DECEMBER 26, 2023

Otsuka Pharmaceutical and Ionis Pharmaceuticals Otsuka Pharmaceutical and RNA therapy company Ionis have entered into a licence agreement for Otsuka to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate donidalorsen in Europe.

Small Molecule 130

Small Molecule Drugs Molecular Biology Bioinformatics 130

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. Consequently, this strategy substantially reduces the failure rate of cancer clinical trials. International Clinical Trials Registry Platform (ICTRP).

Trials 147

Trials Clinical Trials Treatment Research 147

Drug Discovery World

JULY 5, 2023

RA: How is Agilent supporting cancer research? MG: Agilent works as closely as we can with the researchers, clinicians, and pharmaceutical companies that are at the forefront of developing therapeutic strategies to understand what they need from a technical point of view. RA: What’s next for cancer research/the industry?

Research 246

Research Immune Response Pharmaceutical Companies Treatment 246

Drug Discovery World

OCTOBER 16, 2023

Next, Saleko highligts how Northumberland and the North East of the UK are recognised for pharmaceutical manufacturing prowess. According to Dr Michelle Fraser, Business Unit Manager, Base Editing at Revvity: “The UK, and especially the Cambridge region, is well known for its pharmaceutical innovation. billion in funding.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

The Pharma Data

MAY 6, 2021

INDIANAPOLIS , May 6, 2021 /PRNewswire/ — With a goal of integrating data and technology to help streamline diabetes management, Eli Lilly and Company (NYSE: LLY) signed strategic international agreements with four companies – DexCom, Inc., 1 International Diabetes Federation. Glooko Inc. About Glooko Inc. Available at: [link].

International 52

International Therapies Disease Production 52

PPD

JUNE 7, 2023

The need for pediatric pharmaceuticals and biologics to treat the disease is urgent: Estimates project roughly one in 10 children will be afflicted by NAFLD. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

Drug Discovery World

AUGUST 3, 2023

The situation in Europe follows a similar narrative of “more” – more research, more trials, and more results are needed for medical cannabis to reach its full potential. Jazz Pharmaceuticals has supplied the cannabidiol for the trials at no cost.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Drug Discovery World

APRIL 29, 2024

Vrana; Therapeutic Potential of Cannabis, Cannabidiol, and Cannabinoid-Based Pharmaceuticals. Ann Intern Med. Food and Drug Administration perspective on cannabis research and drug development. link] FDA 2023 guidance Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. [link] 2/24/2023.

Research 147

Research FDA Production Drug Development 147

The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. “Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular.

Clinical Research 52

Clinical Research International Clinical Trials Clinical Development 52

The Pharma Data

JUNE 26, 2021

Current AFT studies are funded by a number of pharmaceutical company collaborators and the Patient-Centered Outcomes Research Institute (PCORI). Both international and multidisciplinary, EORTC’s Network comprises over 2800 collaborators involved in cancer treatment and research in more than 740 institutions across 30 countries.

Clinical Trials 52

Clinical Trials International Trials Therapies 52

Vial

MAY 8, 2024

As technological advancements drive the pharmaceutical industry forward, the shift towards digitalization, particularly with electronic data capture (EDC) systems, has become increasingly prominent. Vial seeks to transform clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes.

Clinical Trials 52

Clinical Trials Trials Clinical Research Laboratories 52

Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

Alta Sciences

SEPTEMBER 13, 2023

ELECTRICAL STIMULATION MODELS Using controlled electrical currents, or impulses, scientists can investigate the effects of pharmaceutical compounds on neural muscular or physiological systems. WHY IS PAIN RESEARCH SO IMPORTANT? Some commonly used modes include the Barostat Model, the Staircase Challenge, and Skin Punch. in 2001.

Clinical Trials 52

Clinical Trials Treatment Trials Pharmacokinetics 52

The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

Research 52

Research Vaccine Doctors Pharmaceuticals 52

The Pharma Data

JANUARY 14, 2021

Dr. Dickstein enjoyed 30 years in the pharmaceutical field before retiring in 1998 as the vice president of clinical research for Transcend Therapeutics, Inc. Dickstein remains a pharmaceutical consultant in his hometown of Cohasset, Massachusetts, since 1999.

Laboratories 52

Laboratories Clinical Research Hospitals Pharmaceuticals 52

Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

Drug Discovery World

APRIL 14, 2023

She is also a Professor of Pathology at the Johns Hopkins University School of Medicine, Co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and Deputy Director of the Johns Hopkins Institute for Clinical and Translational Research.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

The Pharma Data

JANUARY 4, 2021

Rothenberg took over as Pfizer CMO in January 2019, but spent more than 12 years in total working for the pharmaceutical giant. 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 52

Pharma Companies Clinical Development Clinical Research International 52

The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. SH) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

The Pharma Data

JANUARY 17, 2021

It was co-sponsored by Merck and Bayer, conducted with the scientific oversight of the Canadian VIGOUR Centre and the Duke Clinical Research Institute. Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co.

FDA 52

FDA Small Molecule Immune Response Hospitals 52

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 52

FDA Approval FDA Clinical Development Clinical Research 52

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

Clinical Research 69

Clinical Research Trials Research Clinical Trials 69

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Drug Discovery World

JANUARY 24, 2023

According to PsychedelicHealth 8 , this sort of research is ‘creating optimism about the potential efficacy of psychedelic drugs as an alternative or supplement to traditionally manufactured pharmaceuticals to treat depression, anxiety, and addiction among other mental health conditions’. The Lancet Oncology. 2020; 21 (5): 624-627.

Clinical Trials 242

Clinical Trials Trials Drugs Treatment 242

The Pharma Data

DECEMBER 27, 2020

Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital. “We China represents a large pharmaceutical market. “Data from trials with orelabrutinib have shown sustained efficacy in the treatment of R/R MCL patients,” said Jun Zhu, M.D.,

Hospitals 52

Hospitals Science Treatment Clinical Trials 52

LifeSciVC

MARCH 20, 2023

During Women’s History Month and in recognition of International Women’s Day the biotech community is celebrating all women who are forging change in our industry. Dr. Ramsey drove cystic fibrosis clinical research to where we are today. She was the final recipient of the Richard C.

Science 40

Science Engineering Therapies Clinical Research 40

The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

Drug Discovery World

APRIL 29, 2024

Bill Dawson, Chair, Medicines Manufacturing Industry Partnership (MMIP): Dawson is Head of Biologics and Devices Manufacturing at GSK and has over 25 years’ experience in the vaccines, biopharma, pharmaceutical and clinical research (CRO) industries.

Drugs 130

Drugs Small Molecule Bioinformatics Pharmaceuticals 130

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40

PPD

APRIL 30, 2024

Our PPD FSP regulatory affairs solutions teams, part of the PPD clinical research business of Thermo Fisher Scientific, regularly gather, assess and determine the impact of CTR intelligence. Compiling a successful EU CTR submission Successful EU CTR submissions are achieved through extensive and coordinated collaboration.

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies.

Bioethics 40

Bioethics Clinical Research Regulations Compliance 40

Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot.

FDA 40

FDA Science Clinical Trials Regulations 40