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. aeruginosa, S. aureus, and K.

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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.

Drug Development 52

Drug Development Clinical Trials Laboratories Compounding Pharmacies 52

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

A 2023 analysis of pooled data from 11 clinical trials of treatments for cocaine use disorder found that reduction in use, as defined by achieving at least 75 percent cocaine-negative urine screens, was associated with short- and long-term improvement in psychosocial functioning and measures of addiction severity 7. doi: 10.1111/j.1530-0277.2010.01290.x.

Treatment 69

Treatment Trials Clinical Trials Drugs 69

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?

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

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

Computational Chemistry Science Clinical Trials Pharmaceutical Companies 52

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. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric.

Clinical Supply 52

Clinical Supply Clinical Trials Doctors Clinical Development 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. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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Disease Clinical Trials Therapies Science 111

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.

Regulations 52

Regulations Production Drugs Clinical Trials 52

Drug Target Review

OCTOBER 17, 2024

Biomarkers are the holy grail of clinical trials. What factors should decision makers consider when selecting patient populations for clinical trials of CD24/Siglec-10-targeted therapies, especially in cases where patients have failed to respond to existing immunotherapies?

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

The Pharma Data

MARCH 22, 2021

Together with our partner Regeneron, we are grateful to the patients and investigators who have participated in ongoing clinical trials and look forward to discussing the growing body of evidence with health authorities and to bringing the treatment to as many people as possible.” About the REGN-COV 2067 trial.

Clinical Trials 52

Clinical Trials Virus Trials FDA 52

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.

Drugs 105

Drugs Metabolic Stability Computational Chemistry Pharmaceuticals 105

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

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.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

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).

Drug Development 52

Drug Development Drugs Virus Science 52

Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. Many of these groups demonstrated the ability of LLMs to ingest large bodies of unstructured clinical data and subsequently generate tables and reports based on natural language queries.

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Drugs Small Molecule Bioinformatics Packaging 139

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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Clinical Trials Trials Production Therapies 40

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).

Government 52

Government Treatment Vaccine Clinical Trials 52

The Pharma Data

AUGUST 1, 2021

The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough. 12,13,14,15.

Trials 52

Trials Therapies Disease Treatment 52

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.

Disease 40

Disease Government Clinical Trials Treatment 40

The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. GlaxoSmithKline plc and Vir Biotechnology, Inc. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

Treatment 40

Treatment Vaccine Virus Trials 40

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.

Science 52

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.

Treatment 40

Treatment Disease Therapies Clinical Trials 40

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. The CHMP scientific opinion under Article 5.3 The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

MAY 13, 2021

based weight loss intervention in adults with obesity: A randomized clinical trial. 2004 Oct;28(10):1344-8. 2004 May 19;124(2):134-42. Journal of Obesity. 2011;2011:651936. DOI: 10.1155/2011/651936. . Daubenmier J, Moran PJ, Kristeller J, et al. Effects of a mindfulness?based Obesity (Silver Spring, Md). DOI: 10.1002/oby.21396.

Disease 52

Disease Production Testimonials Science 52

Codon

JANUARY 26, 2025

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. It’s still in preclinical development, but the hope is to move into clinical trials soon.

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Vaccine Immune Response Virus Clinical Trials 98

FDA Law Blog: Drug Discovery

JANUARY 12, 2025

This may also help to derisk parallel product development amongst multiple products for the same condition, where another product in development may gain traditional approval or another product already on the market under accelerated approval may confirm clinical benefit prior to completion of clinical trials to support accelerated approval (e.g.,

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FDA Clinical Trials Trials Therapies 64

New Drug Approvals

APRIL 5, 2025

15] In February 2004, orphan designation (EU/3/04/186) was granted by the European Commission to medac Gesellschaft fuer klinische Spezialprparate mbH, Germany, for treosulfan for the conditioning treatment prior to haematopoietic progenitor cell transplantation. [16] 155 and Organic.Syntheses, (2004), Coll.Vol.10, to 105 C (214.7

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FDA FDA Approval Production Treatment 62

Codon

NOVEMBER 24, 2024

Petrucci apparently destroyed the embryo, however, because it became “deformed and enlarged, a monstrosity,” according to a 2004 article in The New York Times. The scientific community was immediately skeptical of Petrucci’s claims because his results appeared in a Roman newspaper but never in a scientific journal.

Regulations 62

Regulations DNA Hospitals Trials 62

Codon

FEBRUARY 23, 2025

million by 2004. Near-Perfect Scores Lenacapavir’s excellent features encouraged Gilead to run clinical trials in humans. As 90 percent of drugs that enter clinical trials don’t progress beyond them, pharmaceutical companies capitalize on their wins to continue funding research into new drugs.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68

Drug & Device Law

JANUARY 15, 2024

Indeed, in making [defendant’s] failure to conduct clinical trials or studies of the [product] a central theme of their case, plaintiffs “opened the door” to the admission of 510(k) evidence, notwithstanding the trial court’s exclusion. Ethicon, Inc. , 3d 1245 (N.J. at 354 (citations omitted). Blaw-Knox , 360 F.3d

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Compliance Government Production FDA Compliance 52