LifeSciVC

APRIL 2, 2024

And the experience of those around you, including Board members and internal investors. We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Science 67

Science Small Molecule International Clinical Development 67

Drug Discovery World

JUNE 19, 2024

To address these challenges, we have partnered with European Association of Nuclear Medicine (EANM), the International Atomic Energy Agency (IAEA) and other academia and medical society partners to develop the RLT Academy 13. However, there are currently gaps in education, and training pathways lack alignment across countries 6,10,12.

Therapies 147

Therapies Treatment Regulations Production 147

PPD

NOVEMBER 14, 2023

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. Here’s how we do it. We know that this cultural phenotype is equally as important as the work experience a candidate brings.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

Drug Discovery World

JANUARY 30, 2023

What’s that got to do with clinical trials? Often the opportunity to accelerate the time it takes for new innovations to reach patients comes down to a handful of pivotal moments in a clinical trial. If we focus on trials specifically – patient satisfaction is critical.

Clinical Trials 130

Clinical Trials Trials Clinical Development International 130

Drug Discovery World

SEPTEMBER 14, 2023

Chief Development Officer and Executive Vice President, will be leaving Pfizer to pursue new opportunities outside the company. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. As a result of these moves, William Pao, M.D.,

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

Drug Discovery World

MARCH 2, 2023

DDW’s Diana Spencer reports on the recent Avacta Therapeutics Science Day, which explored the latest exciting developments in targeted treatments for cancer and asked what advances the future might bring. She explained the mechanism by which AVA6000 can provide more precise treatment than current chemotherapies.

Therapies 130

Therapies Treatment Trials Disease 130

Vial

APRIL 10, 2024

IQVIA’s core strengths lie in its specialized global IT infrastructure tailored for healthcare, analytics-driven clinical development, a robust ecosystem of real-world solutions, and an expanding suite of proprietary clinical and commercial applications.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

Clinical Trials 130

Clinical Trials Pharma Companies Biosimilars Production 130

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Click here for available international numbers. UK : +44 203 481 5237. Sweden : +46 8 5052 0017.

Regulations 75

Regulations International Disease Small Molecule 75

The Pharma Data

DECEMBER 29, 2020

Stock Connect allows international and China Mainland investors to trade securities in each other’s markets through the trading and clearing platforms of their home exchange. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators.

FDA 52

FDA Clinical Development Regulations Clinical Trials 52

Drug Discovery World

MAY 16, 2023

Skills gap Bruce Levine, International Society for Cell & Gene Therapy (ISCT) Immediate Past President and Chair, Strategic Advisory Council, says a critical challenge that has become apparent for the CGT sector is the need for workforce development and training resources. What are the global innovations in cell and gene therapy?

Therapies 130

Therapies Clinical Trials Marketing Production 130

The Pharma Data

MARCH 1, 2022

It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development.”

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation. Existing published VCS may be identified internally by FDA or externally by stakeholders. Consensus does not require unanimity, but a general agreement.

Therapies 59

Therapies FDA Production Regulations 59

PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

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.

Small Molecule 52

Small Molecule Clinical Development Production Science 52

The Pharma Data

JULY 21, 2021

“This announcement reflects another important regulatory milestone in the development of this medicine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Treatment 52

Treatment Production Hospitals FDA Approval 52

LifeSciVC

NOVEMBER 16, 2022

From R&D and clinical development to regulatory approval, it takes an average of 12 to 14 years for an idea to become a reality. Developing familiarity with the rigor of SEC regulations and disclosure requirements for public companies early on is important. Biotech leaders need to embody this purpose.

International 40

International Compliance Science Clinical Development 40

Agency IQ

JULY 21, 2023

released both a coordinated plan on artificial intelligence (AI) and a proposal for a regulation. The coordinated plan intends to promote AI innovation by “setting enabling conditions for AI development and uptake in the EU” as well as ensuring “that AI works for people and is a force for good in society.” image refinement).

Science 40

Science Clinical Trials Regulations Trials 40

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. Immune Regulation – U.K.-based

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

The Pharma Data

DECEMBER 9, 2020

Uniquely positioned in the rapidly evolving local biotech ecosystem in China in addition to an expansive global presence, Overland will strategically partner to jointly develop innovative, novel therapeutics. The company will operate in three international offices, Shanghai and Beijing in China and will also have a presence in Boston. .

Therapies 52

Therapies International Disease Research 52

The Pharma Data

JANUARY 25, 2021

“The technology has a unique pharmacological profile, which is very different from other products in preclinical and clinical development in that it focuses on restoring function. All clinical development plans are subject to additional funding. Corey Davis Ph.D., for the latest news on the Company.

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group.

Drugs 237

Drugs Licensing Licensing Regulations 237

The Pharma Data

JANUARY 14, 2021

Clinical Development – Pipeline Review. He is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR) and a member of the steering committee for the International IgA Nephropathy Network. . 3:40pm. .

Clinical Trials 40

Clinical Trials Hospitals Disease International 40

The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. International Immunol. (11):1583 WO 2021/001458 A1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S. 175:1091-1101 (1992) 2 Karpusas, M et al.,

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Clinical Trials 52

Clinical Trials Regulations Therapies Clinical Development 52

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Vaccine 52

Vaccine Immune Response Disease Clinical Trials 52

The Pharma Data

JANUARY 20, 2021

We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Verquvo® (vericiguat) tablets for once daily oral use (2.5

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

Drug Discovery World

JULY 17, 2024

NK: IO builds on the discovery in Brady’s lab of E4BP4 as a central transcriptional regulator of NK cell development, with REV-ERB and Notch receptor as key control points. How soon can we expect a therapy to reach the clinical development phase? Overall, we have raised £5.1m Why did you choose this particular disease?

Therapies 130

Therapies Engineering Small Molecule Clinical Development 130

Drug Discovery World

AUGUST 2, 2023

For instance, protein palmitoylation involves the covalent attachment of fatty acyl chains, typically a palmitate to internal cysteine residues of a protein via labile thioester linkages. Those results led to further clinical development in ongoing larger studies in patients with advanced hepatocellular carcinoma and cholangiocarcinoma.

Small Molecule 130

Small Molecule Immune Response Clinical Trials International 130

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.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy. Haematologica 2010;95(4):567–573.

Treatment 52

Treatment Disease Small Molecule Production 52

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

Clinical Research 69

Clinical Research Trials Research Clinical Trials 69

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). One example of such a genetics exercise is represented in Fig.

Production 115

Production Small Molecule Regulations Trials 115

Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. the ICH quality guidelines), the draft may “introduce redundancy, potentially causing confusion and inefficiency when implementing the outlined concepts in the development of a potency strategy.”

Production 40

Production FDA Therapies Biochemical Assays 40

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. About PXL770.

Trials 52

Trials Disease Treatment Pharmacokinetics 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52