The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

Clinical Development

Drug Target Review

JUNE 6, 2023

However, the protein’s preclinical promise has not yet been replicated in clinical trials, where systemic administration is associated with dose-limiting toxicities and a narrow therapeutic index. Some approaches have already reached the clinical trial stage, with others not far behind.

Engineering

Drug Target Review

APRIL 3, 2024

Everything started in school with an experiment on isolating DNA from bananas. Making a little tangle of DNA visible to the eye and understanding that this is the basis of complex organisms, which might be altered in disease, was the defining moment for my future path in life sciences. in North America) in late 2017.

Science

Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

Drug Development

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. Genetic Factors : Certain genetic mutations, such as those in DNA repair genes, can affect how cells respond to radiation.

Clinical Trials

The Pharma Data

OCTOBER 19, 2020

With over 300 active clinical trials, Winship researchers are dedicated to taking new cancer treatments from bench to bedside. cancer centers selected as a Lead Academic Participating Site for the NCI’s National Clinical Trials Network (NCTN). Winship is one of 32 U.S.

Clinical Trials

The Pharma Data

JANUARY 27, 2021

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

Therapies

PerkinElmer

MAY 6, 2022

For example, the STimulator of InterferoN Genes (STING) pathway, which is known to play a critical role in innate immunity in response to viral and bacterial DNA, has also been shown to promote anti-tumor immune responses. Researchers are therefore exploring the development of synthetic STING activators as potential cancer therapeutics.

Immune Response

The Premier Consulting Blog

MARCH 7, 2024

Depending on the gene therapy vector, microbial systems may be employed to produce vector DNA (such as in adeno associated virus (AAV)), in which case there may be bacterial cell banks and plasmid banks. A more rigorous identity test may sometimes be required, such as DNA sequencing of the entire AAV genome.

Production

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

FDA Approval

The Pharma Data

AUGUST 6, 2020

The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers. Outside of China, BioNTech and its partner Pfizer launched their 30,000-subject phase 3 efficacy trial last week. China has several home-grown COVID-19 vaccines in clinical development.

Vaccine

The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

Pharmaceuticals

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

Small Molecule

Drug Target Review

AUGUST 16, 2024

She has also served as a leader in clinical development and medical affairs at AbbVie, Kimberly-Clark and Johnson & Johnson. In those roles, she oversaw the direction, planning, execution and interpretation of clinical trial data.

Medical Schools

Alta Sciences

APRIL 17, 2024

Several viral vectors are being used currently, in addition to non-viral vectors, such as oligonucleotides, naked DNA, and lipoplexes and polyplexes. Fifteen oligonucleotides have so far received market authorization in different countries, and several others are being test in clinical Phase I to III trials. Asia, and Europe.

Drug Development

The Pharma Data

APRIL 11, 2023

Based on these data, a first-in-human trial with BAY 2965501 in patients with advanced solid tumors was initiated and is currently enrolling patients. Both small molecule inhibitors in Immuno-Oncology are being jointly developed in a strategic research alliance with the German Cancer Research Center (DKFZ) in Heidelberg, Germany.

Research

The Pharma Data

OCTOBER 14, 2020

Assistant Professor of Medical Sciences at Columbia University Vagelos College of Physicians and Surgeons, is designed to generate DNA aptamer-based anti-idiotypes to selected monoclonal antibodies identified in Dr. Ilya Trakht’s study. The study led by Dr. Sergei Rudchenko, Ph.D., About TNX-1800.

Vaccine

Nvidia Developer: Drug Discovery

MARCH 21, 2023

New supercomputing-scale large language models (LLMs) that understand biology and chemistry text are helping scientists understand proteins, small molecules, DNA, and biomedical text. After Exscientia brought an AI-designed drug candidate to a clinical trial in 2021, several other companies have announced that their candidates are in trials.

Small Molecule

The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians. Forward-Looking Statements.

Therapies

Agency IQ

APRIL 12, 2024

Not only are assays useful tools for characterizing products early in development; they can also be used to set “benchmarks,” allowing sponsors to verify that the lots of the product used during clinical trials and eventually, for commercial distribution, continue to adhere to the same standards specified in the original product’s design.

Production

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products.

Biosimilars

Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

Research

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. 1. -- -->. -- [if lte IE 8]--> . adults age 65 and older.

Clinical Trials

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials

The Pharma Data

JANUARY 20, 2021

Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, today announced the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50

DNA

The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. Results from the CheckMate -142 trial at minimum follow-up of 46.9 To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment

The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

FDA

The Pharma Data

NOVEMBER 29, 2020

(NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. 1 Gilbert C and Boivin G.

Vaccine

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development

Codon

MARCH 20, 2023

Digital nanoreactors to control absolute stoichiometry and spatiotemporal behavior of DNA receptors within lipid bilayers. CRISPR-induced DNA reorganization for multiplexed nucleic acid detection. Combining fusion of cells with CRISPR-Cas9 editing for the cloning of large DNA fragments or complete bacterial genomes in yeast.

Virus

The Pharma Data

FEBRUARY 22, 2022

He is co-founder and non-executive board member of the Hartwig Medical Foundation (large scale DNA analyses) and is a board member of the Center for Personalized Cancer Treatment and leads several innovative precision oncology clinical trials. He began his oncology development career at Rhône Poulenc Rorer Inc.

Clinical Trials

Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

Drug Development

Codon

MARCH 24, 2024

Water accounts for 70 percent of a bacterium by mass; the other 30 percent includes everything else: proteins, RNA, DNA, lipids, and so on. by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial.

Vaccine

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. 7 Recent clinical studies highlight promising developments in c-MET-targeting ADCs for NSCLC. 2024;347:122676. BMC Cancer. 2024;24(1):898.

Therapies

The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. Frazier, chairman and chief executive officer, Merck. “I Financial Summary.

Vaccine

The Pharma Data

MARCH 15, 2022

The trial’s other dual primary endpoint, radiographic progression free survival (rPFS), was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm. In collaboration with AstraZeneca, Merck is evaluating LYNPARZA in combination with abiraterone in the Phase 3 PROpel trial.

DNA

The Pharma Data

DECEMBER 16, 2020

However, its efficacy is quite a bit lower than the mRNA vaccine developed by Pfizer and BioNTech, which has a 95% efficacy, and one developed by Moderna, which has a 94% efficacy. During Phase III trials, one of the cohorts was administered one and a half doses, as opposed to two full doses. AstraZeneca’s efficacy is at 70.4%.

Vaccine