Article, Licensing and Pharmacokinetics

Toxicology transformed: Why accuracy now leads the way

Drug Target Review

DECEMBER 11, 2024

In this article, we share our hard-earned insights into overcoming these critical challenges. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

International

International Laboratories Drugs Pharmacokinetics

The future of mental health treatment: Zelquistinel’s role

Drug Target Review

MARCH 17, 2025

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. Donello was most recently Vice President of External Science & Innovation at Allergan/AbbVie, where he led R&D innovation efforts to develop strategic collaborations, in-license clinical-stage assets and evaluate M&A opportunities.

Treatment

Treatment Licensing Licensing Science

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

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

Clinical Development Disease Treatment Licensing

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. This study is planned to start in late 2024 and conclude in late 2025.

FDA

FDA Trials Therapies Regulations

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. Ronapreve is being jointly developed by Roche and Regeneron.

Treatment

Treatment Virus Clinical Trials Pharmaceuticals

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Thanks for skimming. ❤️ Subscribe to support human writers. Ricciardi M.J.

DNA

DNA RNA Engineering Licensing

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.”

Biosimilars

Biosimilars Science FDA Production

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

The article, entitled “Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study,” is available online at: [link]. License and research and development revenue. CTP-692: An Investigational Adjunctive Treatment for Schizophrenia. 2019. .

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Treatment

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

The CHMP scientific opinion under Article 5.3 Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

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.

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

BENZGALANTAMINE

New Drug Approvals

APRIL 2, 2025

Article ] Bakker C, van der Aart J, Hart EP, Klaassen ES, Bergmann KR, van Esdonk MJ, Kay DG, Groeneveld GJ: Safety, pharmacokinetics, and pharmacodynamics of Gln-1062, a prodrug of galantamine. Alzheimers Dement (N Y). 2016 Jan 20;2(1):13-22. doi: 10.1016/j.trci.2015.12.003. 2015.12.003. eCollection 2016 Jan. Alzheimers Dement (N Y).

FDA

FDA FDA Approval Treatment Disease

TREOSULFAN

New Drug Approvals

APRIL 5, 2025

“Treosulfan Pharmacokinetics and its Variability in Pediatric and Adult Patients Undergoing Conditioning Prior to Hematopoietic Stem Cell Transplantation: Current State of the Art, In-Depth Analysis, and Perspectives” Clinical Pharmacokinetics. This article incorporates text from this source, which is in the public domain.

FDA

FDA FDA Approval Production Treatment

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

This article concludes Issue 05. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Pharmaceutical developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted. million by 2004.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Drug Discovery Digest

Toxicology transformed: Why accuracy now leads the way

The future of mental health treatment: Zelquistinel’s role

Webinars

Trending Sources

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

Webinars

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Codon Digest: Injected Gene Editors

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

BENZGALANTAMINE

TREOSULFAN

Making a “Miracle” HIV Medicine

Stay Connected