DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. pending further litigation, illustrating the increasing regulatory challenges faced by pharmaceutical companies pursuing large-scale mergers.

Pharmaceuticals 69

Pharmaceuticals Pharmaceutical Companies Marketing Therapies 69

Drug Discovery World

OCTOBER 16, 2023

The United Kingdom has established itself as a hub for drug discovery expertise worldwide. There is a range of reasons why this area has become focal point for drug discovery, one of which is the fact that it encompasses the University of Oxford and the University of Cambridge, two of the oldest and most prestigious universities in the world.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD.

Disease 52

Disease Drugs Treatment Drug Development 52

Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The post Pfizer launches Phase III trial for Lyme disease vaccine appeared first on Drug Discovery World (DDW). Official comments . February 2022. Available at:?

Vaccine 130

Vaccine Disease Trials Pharmaceutical Companies 130

Drug Discovery World

JANUARY 31, 2023

Teams must plan for post-approval activities while managing spend—and waiting nervously for regulatory approvals like their Prescription Drug User Fee Act (PDUFA) date to arrive. Savvy organisations anticipate these challenges early in the drug approval process. A key starting point is to design a digital workflow.

Production 246

Production Engineering Pharmaceutical Companies Clinical Trials 246

The Pharma Data

JANUARY 17, 2021

18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

Crown Bioscience

MAY 4, 2021

Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Not failed drugs, but failed studies. As soon as drug developers can begin to develop conviction, momentum increases.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

Molecule Blog

JANUARY 9, 2023

In this context, we are building a new intellectual property (IP) system and structure that enables broad collaboration and incentivizes the right participants (including AI drug hunters or contract research organizations) to contribute to research. How will IP-NFTs enable drug development in the future?

Research 52

Research Licensing Licensing Science 52

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). What is the regulatory landscape of medical cannabis?

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Drug Discovery World

MARCH 7, 2023

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing.

International 246

International Science Pharmaceuticals DNA 246

The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda. – Ends-.

Licensing 52

Licensing Licensing Pharmaceutical Companies Engineering 52

Molecule Blog

AUGUST 19, 2021

In drug development however, when a therapeutic is discovered, or research becomes more akin to product development, the source of funding must change. These grants are utilised by researchers to get to the point of developing a potentially life-saving therapeutic. And this is the best-case scenario. for patents)?

Research 52

Research Licensing Licensing Drug Development 52

Drug Discovery World

OCTOBER 10, 2022

Will an expansion in the use of effective digital biomarkers help improve the productivity of drug development in neuroscience? Increasingly, digital biomarkers are becoming more effectively used in the discovery and development of drugs that act in the central nervous system.

Drug Development 130

Drug Development Clinical Trials Drugs Trials 130

The Pharma Data

DECEMBER 9, 2020

Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

JANUARY 27, 2021

The Company’s validated, proprietary F.I.R.S.T technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. The FTD is designed to make important new drugs accessible to patients faster.

FDA 52

FDA Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

RNA 52

RNA Protein Expression Therapies Disease 52

Drug Discovery World

MAY 11, 2023

An ovarian cancer drug, which targets the alpha folate receptor (FRα), is set to enter Phase II trials. Idetrexed (formerly known as BTG945, ONX-0901 and CT900) was created by scientific teams in what is now The Institute of Cancer Research (ICR) Centre for Cancer Drug Discovery, London, UK.

Trials 130

Trials Small Molecule Drugs Pharmaceutical Companies 130

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease 40

Disease FDA Clinical Trials Licensing 40

Drug Discovery World

MARCH 6, 2024

To find new ways of diagnosing and treating complex diseases we first must understand the mechanisms underpinning their key pathological drivers, how these relate to different patient subgroups, and which drugs might be useful in ameliorating their effects – this is the basis of precision neuroscience. This is wholly unsurprising.

Clinical Trials 162

Clinical Trials Pharmaceutical Companies Disease Trials 162

The Pharma Data

OCTOBER 29, 2020

Food and Drug Administration with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. have collaborated on the development and commercialization of aducanumab globally.

Marketing 40

Marketing Disease Clinical Trials Treatment 40

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

Drug Development 52

Drug Development Disease Engineering Therapies 52

The Pharma Data

SEPTEMBER 8, 2020

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 8, 2020

United States Food and Drug Administration. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. About the Janssen Pharmaceutical Companies of. We’re the Pharmaceutical Companies of. www.jnj.com.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either.

Engineering 125

Engineering Virus DNA Therapies 125

Altus Drug Development

MAY 31, 2022

Thanks to oral formulation, many drugs crucial for the health and well-being of millions of people can be administered and save countless lives. The field of drug formulation is in a constant state of innovation, creating a plethora of challenges to overcome, but also opening up a world of opportunities. What is oral formulation?

Pharmaceuticals 52

Pharmaceuticals Drug Development Production Pharmaceutical Companies 52

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 118

Therapies Virus DNA Clinical Trials 118

NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

In an analysis of more than 28 million papers in the PubMed.gov database , researchers found NIH contributed to published research that was associated with every single one of the 210 new drugs approved by the Food and Drug Administration from 2010 through 2016 [1]. This first exercise resulted in a list of 210 new drugs.

Research 52

Research Science FDA Pharmaceutical Companies 52

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. Novartis is making multiple contributions to the global efforts to combat the COVID-19 pandemic. About Molecular Partners AG.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. If approved, the company can then market and distribute the therapeutic. However, centralization has its advantages in specific scenarios.

Engineering 52

Engineering Research Government Clinical Trials 52

Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

FDA 40

FDA Science Regulations Production 40

Drug Discovery World

NOVEMBER 10, 2023

AH : I am Chief Business Officer for Antibody Analytics, a collaborative immunology CRO, specialising in supporting immunotherapy developers at the discovery to pre-clinical stages of the drug development process. It was my first foray into investigational drug testing in clinical trials and I found it very rewarding.

Molecular Biology 147

Molecular Biology Clinical Trials Licensing Licensing 147

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. drug development initiative from 2012 to February 2019. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Trials Production International 40

The Pharma Data

DECEMBER 30, 2020

Food and Drug Administration (FDA), noted in December 2020 that he expected the pandemic could “effectively” be ended in 2021 with the launch of the Pfizer-BioNTech and Moderna vaccines. Then, in July, after analyzing completed data and with talks with the FDA, they decided they were going to pursue regulatory approval for the drug.

Vaccine 52

Vaccine FDA Trials Therapies 52

The Pharma Data

DECEMBER 15, 2020

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

Clinical Trials 52

Clinical Trials Trials Treatment Therapies 52