Formulation Changes and Bridging During Formulation Development – Part 2
It focus on the real-life examples of bridging studies due to formulation changes from clinical study to commercialization of drug and real-life examples of bridging studies due to Reformulation (formulation changes) post commercialization of drug.
November 22, 2024
by Deepak Hegde
Formulation Changes and Bridging During Formulation Development – Part 1
an outline of formulations change during development, details of the kind of Formulation changes from Phase 1 clinical study to commercialization of drug, Formulation changes Post-Approval and Commercialization.
November 22, 2024
by Deepak Hegde
PD-1 Inhibitor Combined with ADC, the Strong Cooperation of Innovent and Remegen
Recently, Innovent and Remegen will carry out a clinical research cooperation on the combination of Sintilimab Injection, a PD-1 inhibitor, with RC88, a novel antibody-drug conjugate targeting MSLN, and RC108, a novel ADC targeting c-MET, res.
July 25, 2023
by Far-away from the Crowd/PharmaSources
InnoCare and Keymed Jointly Announce First Subject Dosed in Clinical Trial of CCR8 Monoclonal Antibody ICP-B05
InnoCare Pharma and Keymed Biosciences that the first subject has been dosed in clinical trial of ICP-B05.
February 24, 2023
by PharmaSources
SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab
SOTIO Biotech announced today that the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and cetuximab in patients with colorectal cancer.
January 19, 2023
by PharmaSources
HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations
HighTide Therapeutics announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund.
January 5, 2023
by PharmaSources.com
Thermo Fisher Scientific Partners with Medidata Acorn AI to Optimize Clinical Research Site Selection and Speed Patient Enrollment in Clinical Trials
Thermo Fisher Scientific has announced a multiyear partnership with Medidata Acorn AI, a Dassault Systèmes company. Through this partnership, the PPD clinical research business of Thermo Fisher has collaborated with Medidata...
February 10, 2022
by AmericanPharmaceuticalReview
Taysha Gene Therapies Announces Positive Safety Data from UT Southwestern-Sponsored Clinical Trial for the Treatment of CLN7 Batten Disease at 18th Annual WORLDSymposium
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases...
February 10, 2022
by FirstWordPharma
HanAll Biopharma Reports Full-Year 2021 Results and Provides Business Update
HanAll Biopharma (KRX: 009420.KS) announced today that it achieved 101.6 billion won in sales in 2021, a 15% increase from the previous year. It had 10.1 billion won in operating profit, a 70% increase year-on-year...
January 21, 2022
by prnasia
Suvoda Exceeds 2021 Targets; Poised for Continued Growth Supporting Complex Clinical Trials in 2022
Suvoda, LLC, a global clinical trial technology company that specializes in highly complex studies, such as oncology, central nervous system (CNS) and rare disease...
January 21, 2022
by prnasia
Catalent Launches New Xpress Pharmaceutics Service
Expedites development of oral drugs for adaptive phase 1 clinical trials.
January 18, 2022
by contractpharma
Green Valley Obtains IND Approval from U.S. FDA for Sodium Oligomannate's Global Phase II Clinical Trial in Treating Parkinson's Disease
Green Valley (Shanghai) Pharmaceuticals Co., Ltd. received the letter from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the global multi-center phase-II clinical trial of Oligomannate...
January 17, 2022
by prnasia