The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. RYBREVANT™ IMPORTANT SAFETY INFORMATION 7. In 2018, Janssen Biotech, Inc.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964.

Research 40

Research Clinical Trials Small Molecule Trials 40

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. For more information, please visit www.bioxceltherapeutics.com. Contact Information: BioXcel Therapeutics, Inc. Forward-Looking Statements. www.bioxceltherapeutics.com.

Treatment 52

Treatment Trials FDA Hospitals 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

Treatment 52

Treatment Disease Small Molecule Production 52

The Premier Consulting Blog

JULY 31, 2024

A key difference is that the Sponsor of a 505(b)(1) NDA owns or has right of reference to the safety and effectiveness information versus the Sponsor of a 505(b)(2) NDA leverages information from other drug approval packages and/or published information they do not own or have right of reference to.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Drug Target Review

OCTOBER 3, 2024

In light of these key developments, the need for flexible yet highly specific and sensitive tools that provide vital information on a drug’s safety and efficacy are essential to help determine the best drug candidates for preclinical and clinical progression. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

JULY 21, 2021

For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-Looking Statement of Merck & Co.,

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. IMPORTANT SAFETY INFORMATION. For additional safety information, please see the full.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. NASH Investor Event Information. For more information, please visit: www.poxelpharma.com.

Trials 52

Trials Disease Treatment Pharmacokinetics 52

The Pharma Data

APRIL 11, 2021

i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION FOR RETEVMO ® (selpercatinib). Please see full Prescribing Information for Retevmo. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 4, 2020

Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). For more information, please visit www.polyphor.com.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). Human and mouse genetics can inform not only efficacy but also safety.

Production 117

Production Small Molecule Regulations Trials 117

Agency IQ

AUGUST 9, 2024

Per Section 3602 of the Consolidated Appropriations Act, this guidance should include information about the specific format and content of the plans, such as the rationale for enrollment goals (e.g., For products under an IDE, DAP information must be submitted with the IDE. What programs or products need a DAP?

Science 40

Science FDA Production Trials 40

Metabolite Tales Blog

JANUARY 23, 2024

[link] [3] FDA prescribing information for daprodustat. link] [5] FDA prescribing information for fezolinetant. link] [10] FDA prescribing information for gepirone. Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As For more information, visit www.selvarx.com. Source link.

Treatment 52

Treatment Small Molecule Virus Pharmacokinetics 52

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. These data may help advance the understanding of HD and inform future treatment approaches for this rare, neurological condition. Spinal Muscular Atrophy (SMA).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

PPD

JUNE 20, 2023

Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy? A strong CRO partner will also talk through your holistic data strategy early, pinpointing milestones at which data could expedite development and approval. Make sure your CRO stays ahead of the curve.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

Agency IQ

AUGUST 16, 2024

The MTD approach evaluates only a few patients at each dose, utilizes a short observation period to observe dose-limiting toxicities (DLTs), and provides limited information on safety beyond DLTs, making it challenging to get a realistic picture of long-term safety and tolerability.

Production 40

Production FDA Science Clinical Trials 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. The enrollment goals should be informed by the estimated prevalence or incidence of the disease or condition in the U.S.

FDA 59

FDA Clinical Trials Disease Trials 59

Metabolite Tales Blog

APRIL 4, 2023

The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer. Acta Pharm Sin B. 2018 Sep;8(5):721-732. link] [3] Bauman et al., J Am Acad Dermatol.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. For more information, please visit www.ascendispharma.com.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib). 30-89 mL/min).

Trials 52

Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

MAY 7, 2021

About the Sotrovimab Clinical Development Program. For further information please visit www.gsk.com/about-us. Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. About Vir Biotechnology.

Treatment 52

Treatment Vaccine Virus Trials 52

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. .

Small Molecule 40

Small Molecule Clinical Trials Trials Therapies 40

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product.

FDA 40

FDA Small Molecule Science Immune Response 40

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 40

Clinical Trials Trials Treatment Disease 40

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52