Perficient: Drug Development

OCTOBER 20, 2023

While it proved to be tricky to find an opening for an infant, we endeavored to compare in-home daycares and licensed facilities. In contrast, the licensed facilities we used maintained extended afternoon hours, providing a tad more flexibility for evening pickups. Luckily, Perficient is very family friendly.

Licensing 52

Licensing Licensing Doctors Regulations 52

Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors. Get ahead now by requesting a trial. already a member?

Targeted Protein Degradation 130

Targeted Protein Degradation Computational Chemistry Trials Licensing 130

Drug Target Review

MARCH 17, 2025

Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD). Donello has led numerous international scientific collaborations, acquisition integrations, and the in-licensing and out-licensing of various drug programmes.

Treatment 52

Treatment Licensing Licensing Science 52

Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall. Obesity is rising worldwide, driven by lifestyle, diet, and genetics.

Therapies 52

Therapies Treatment Clinical Trials Science 52

The Pharma Data

DECEMBER 2, 2020

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates. ” Dr. .”

Licensing 52

Licensing Licensing Vaccine Virus 52

Broad Institute

JULY 25, 2024

Researchers identify cheap and effective biomarkers for DCIS tumor stage By Tom Ulrich July 25, 2024 Breadcrumb Home Researchers identify cheap and effective biomarkers for DCIS tumor stage New study shows how leveraging unsupervised learning can decode DCIS progression from chromatin images.

Research 69

Research Disease Treatment Clinical Trials 69

Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

Research 52

Research Clinical Trials Licensing Licensing 52

DrugBank

AUGUST 15, 2024

This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks. Their established infrastructure, including access to patient populations and clinical trial sites, can significantly accelerate the development timeline.

Drug Development 98

Drug Development Clinical Trials Drugs Therapies 98

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 123

Vaccine Trials Disease Treatment 123

Drug Target Review

FEBRUARY 9, 2024

What are the current challenges and limitations surrounding stem cell therapy in preclinical studies, and how are these issues addressed to ensure the safety and efficacy of potential treatments before advancing to clinical trials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.

Therapies 105

Therapies Immune Response Clinical Trials Treatment 105

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Licensing 52

Licensing Licensing Therapies Engineering 52

Drug Hunter

APRIL 20, 2023

The molecule was the first allosteric TYK2 inhibitor to enter clinical trials, is the first JAK-family kinase inhibitor approved for psoriasis, and is also the first approved drug targeting a pseudokinase domain. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: LP0200 has completed a Ph.

Small Molecule 130

Small Molecule Clinical Trials Trials Licensing 130

Codon

FEBRUARY 13, 2024

Goodsell, RCSB Protein Data Bank and Scripps Research. 1 Yet even after more than two decades of research, media hype, and dozens of clinical trials and biotech start-ups that have come and gone, phage therapy has not scaled. Tom Ireland writes about the companies and technologies that are reimagining phage therapy.

Therapies 128

Therapies Virus DNA Clinical Trials 128

The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

Vaccine 52

Vaccine Trials Licensing Licensing 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

New Drug Approvals

APRIL 2, 2025

acting director of the FDA’s Center for Drug Evaluation and Research. The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. ESI-MS m/z calc.475.0922, 475.0922, found 476.4 (M+1)

FDA 62

FDA Therapies Trials Treatment 62

Molecule Blog

JANUARY 9, 2023

The future of research is collaborative, digital, and highly autonomous. Research is built on data (and sometimes code) that routinely isn’t shared, affecting our ability to replicate science. Researchers make proposals to the system for projects that contribute to solving the disease. Patents today are not.

Research 52

Research Licensing Licensing Science 52

The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology. “As Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements.

Licensing 52

Licensing Licensing Production Clinical Trials 52

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 In Britain, 2.88 In Britain, 2.88

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52

Trials Virus Long-Term Care Facilities Government 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

JANUARY 24, 2021

“We are delighted to be collaborating with the world-renowned researchers at BIDMC, as their cutting-edge research and development work is crucial in bringing potentially life-saving medicines to patients in need of new treatment options.” ZUG, Switzerland , Jan. Chief Medical Officer of Quercis Pharma.

Licensing 40

Licensing Licensing Clinical Trials Medical Schools 40

The Pharma Data

AUGUST 20, 2020

Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1

FDA Approval 52

FDA Approval Vaccine Trials Licensing 52

The Pharma Data

OCTOBER 19, 2020

We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.” In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Treatment 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

Drug Target Review

DECEMBER 11, 2024

As a contract research organisation, we have supported numerous clients in overcoming matrix interference, particularly small and emerging biotherapeutics developers who may lack the in-house expertise to navigate such complex problems. This highlights its vital role in modern biotherapeutic research.

International 52

International Laboratories Drugs Pharmacokinetics 52

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows). based sites.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. BioDAOs fund and incubate projects during the initial stages of translational research, often through IP-NFTs, even before a company is established.

Engineering 52

Engineering Research Clinical Trials Government 52

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Codon

JULY 14, 2024

The creation of synthetic blood is one of the holy grails of biomedical research as it would alleviate such shortages and overcome current barriers to obtaining and storing blood products. However, the subsequent death of another patient thrust Denys into a contentious trial. to the European and Pacific fronts unfeasible.

Production 140

Production Clinical Trials Trials Therapies 140

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., Join the club.

Small Molecule 140

Small Molecule Trials Therapies Disease 140

The Pharma Data

MARCH 30, 2021

In particular, our expectations regarding the FAP targeting agents, including FAPI-46 and FAPI-74,could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global (..)

Therapies 52

Therapies Licensing Licensing Protein Expression 52

The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52