Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. 2 The specificity issue also makes it difficult to test phage therapies in a conventional clinical trial. Still, researchers are trying.

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PLOS: DNA Science

MARCH 28, 2024

The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis. Initial clinical trials introduced the gene into boys’ toes, to limit the damage should adverse effects arise.

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Drug Target Review

JUNE 19, 2024

That would provide wonderful information as we think about then going into a first-in-human clinical trial. From 2002 until 2004, Mr Culley was Director of Business Development and Marketing for Immusol, Inc. Do they affect the hearing capability of this species? Regarding your PNC1 candidate, what conditions is PNC1 intended to treat?

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Drug Target Review

SEPTEMBER 21, 2023

2004) ‘An investigation of persistent microfilaridermias despite multiple treatments with ivermectin, in two onchocerciasis-endemic foci in Ghana’, Annals of Tropical Medicine & Parasitology, 98(3), pp. doi: 10.1002/14651858.CD011146.pub2. Awadzi, K et al. doi: 10.1179/000349804225003253. doi: 10.1093/cid/civ363.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Clinical Trials Treatment Trials Small Molecule 40

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 And integration with our CDMO ensures the clinical trial drug product is available on time. Altasciences has U.S.

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Sygnature Discovery

JULY 31, 2023

Founded in 2004, the company has successfully delivered over 40 novel drug candidates into pre-clinical development and 22 into clinical trials, with its scientists named on over 170 patent applications. Its staff of over 1,000, which includes 900 scientists, partners with global pharma, biotech and NFP organisations.

Computational Chemistry 52

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Drug Target Review

OCTOBER 17, 2024

The broad regulatory function of this pathway suggests that we do not need to limit our clinical strategy until more information is gathered in the FIH trials. The results from such trials would inform whether and how future combination trials should be designed. Biomarkers are the holy grail of clinical trials.

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The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. 12,13,14,15. 12,13,14,15. Saphnelo is under regulatory review for SLE in the EU and Japan.

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The Pharma Data

SEPTEMBER 15, 2020

Enrolling study subjects, setting up patient randomization and managing drug supply are critical to the success of a clinical trial. She continued her career as a health economist and in 2004, Seredina joined S-Clinica. She began her career at S-Clinical as a business developer and progressed to be the Head of Operations.

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Clinical Supply Clinical Trials Doctors Clinical Development 52

The Pharma Data

MARCH 22, 2021

Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab. Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers).

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,040 codified at 21 C.F.R.

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The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). Roche will continue to monitor the evolving clinical evidence for Actemra/RoActemra in this setting.

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Drug Target Review

SEPTEMBER 20, 2023

How AI/ML technology has accelerated drug discovery Although AI for drug discovery (AIDD) can be viewed as being in the initial phases of development and acceptance, compounds discovered using AIDD platforms are already entering clinical trials.

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Sygnature Discovery

OCTOBER 10, 2023

Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents. Its team of over 1,000 employees, which includes 900 scientists, partners with global pharma, biotech, and NFP organizations.

Small Molecule 52

Small Molecule Drugs Disease Clinical Trials 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. 2004 Feb 6;303(5659):808-13. Sci Transl Med. 2017 Mar 29;9(383):eaag1166. Doi: 10.1126/scitranslmed.aag1166. PMID: 28356508; PMCID: PMC6321762.

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The Pharma Data

NOVEMBER 17, 2021

About global access to sotrovimab Sotrovimab is authorised for exigency use in the United States and entered a positive scientific opinion under Composition 5 (3) of Regulation726/2004 from the Committee for Human Medicinal Products (CHMP) in the European Union (EU).

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NIH Director's Blog: Drug Development

OCTOBER 27, 2020

They did the same for the related coronaviruses: SARS-CoV-1, the virus responsible for outbreaks of Severe Acute Respiratory Syndrome (SARS), which ended in 2004; and MERS-CoV, the virus that causes the now-rare Middle East Respiratory Syndrome (MERS).

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The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. 11):1583 (2004) 6 Karpusas M, et al. Collaborating with a team at Biogen Inc., International Immunol. (11):1583

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Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. These information retrieval capabilities have many applications, from writing computer code and collating clinical trial results to summarizing papers on a specific topic. What’s old is new again.

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The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. About the COMET-ICE Study Design.

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The Pharma Data

NOVEMBER 11, 2021

In parallel to the EMA’s rolling review, the CHMP issued a scientific opinion (under Composition 5 (3) of Regulation726/2004) in February 2021, supporting the use of Ronapreve as a treatment option for cases with verified COVID-19 who don’t bear oxygen supplementation and who are at high threat for progressing to severe COVID-19.

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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. Before joining Acorda, Ms.

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. ” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. Across all treatment arms, the trial will enroll up to 3,300 participants. Bamlanivimab alone.

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Treatment Hospitals Long-Term Care Facilities Therapies 40

Practical Cheminformatics

JUNE 12, 2023

In the figure below, I performed 1000 trials, selecting a random LogS value from the BSD and adding normally distributed noise from a normal distribution centered at 0 with standard deviations of 0.17, 0.5, Modeling Aqueous Solubility with ESOL John Delaney published one of the simpler methods for predicting aqueous solubility in 2004.

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Drugs Trials 121

Molecular Design

JANUARY 27, 2019

Imagine if they ran clinical trials like this? As my response below indicates, Reviewer A's comment is more what one might have expected from an inquisitor at a fifteenth century heresy trial than from an expert reviewer of a manuscript submitted to the premier medicinal chemistry journal.

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Science Clinical Trials Trials Drugs 52

The Pharma Data

JUNE 18, 2021

2,4 This analysis included data pooled from six rheumatoid arthritis Phase 3 clinical trials and included more than 3,000 patients with over 7,000 PY of exposure of RINVOQ 15 mg, as well as data of HUMIRA and MTX. More information on this trial can be found at www.clinicaltrials.gov (NCT02629159). years of treatment. doi: 10.1002/art.41032.

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Codon

MARCH 28, 2023

There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The money was earmarked for human trials and, afterward, to develop a neural prosthesis that could augment memories in healthy adults. ” Musk later wrote a check for one million dollars.

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Engineering Research Science FDA Approval 52

The Pharma Data

MAY 13, 2021

Lipitor: Thief of Memory, 2004), cancro. Un’altra analisi del 2010 riguardante 13 prove cliniche con. oltre 92 mila partecipanti ha trovato che la terapia con statine era associata ad aumento. del rischio di diabete. Fonte: Sattar, N., Murray, H., Statins and risk of. incident diabetes: A collaborative meta-analysis of randomised statin.

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FDA Production Vaccine Trials 52

Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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The Pharma Data

MAY 13, 2021

based weight loss intervention in adults with obesity: A randomized clinical trial. 2004 Oct;28(10):1344-8. Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial. 2004 May 19;124(2):134-42. De Araujo IE.

Disease 52

Disease Production Testimonials Science 52

Codon

JANUARY 26, 2025

They ran extensive trials and experiments to inoculate people against this perennial killer. Making Universal Vaccines Though none are yet approved, at least 207 universal flu vaccine candidates are in development, with 165 in preclinical trials and 42 in clinical trials, according to the Universal Influenza Vaccine Tracker.

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Vaccine Immune Response Virus Clinical Trials 101

New Drug Approvals

APRIL 5, 2025

14/L Trial II (NCT00822393), a randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation. 155 and Organic.Syntheses, (2004), Coll.Vol.10, It is pertinent to mention that Organic Syntheses (2004), Coll.Vol. Organic Syntheses, Coll.

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FDA FDA Approval Production Treatment 62

FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Despite including guidance on confirmatory trials and FDAs authority to require them, the Agency decided to publish an additional guidance focused solely on how it is interpreting the authority to require that such trials be underway prior to accelerated approval or within a specified time period after the date of accelerated approval.

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Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004.

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Codon

FEBRUARY 23, 2025

million by 2004. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. For instance, a Johnson & Johnson vaccine failed in late-stage trials in 2023, and Merck ended its Ad5 HIV vaccine trial after data suggested an increased risk of HIV infection among recipients.

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