Formulation Development
Ascendia Pharmaceuticals Secures Growth Equity Investment From Signet Healthcare Partners
Ascendia Pharmaceuticals, Inc. is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical-stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners….
TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility
TCR2 Therapeutics Inc. recently announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. for an existing 85,000-sq-ft cell therapy…
Provectus Biopharmaceuticals Receives Notice of Allowance for Adult Solid Tumor Cancer Combination Therapy Patent
Provectus recently announced the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 16/678,133, which covers the use of intralesional (aka…
Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection
Amphastar Pharmaceuticals, Inc. recently announced that the US FDA approved the company’s Abbreviated New Drug Application (ANDA) for Dextrose injection 50% in the 50-mL Luer-Jet…
Micropore Technologies Appoints New Sales Development Director for the Americas
UK-based particle engineering specialist Micropore Technologies has just announced the appointment of Dr. Camden Cutright as its new Sales Development Director based in the US.…
BridgeBio Pharma’s Affiliate QED Therapeutics & Helsinn Group Announce Strategic Co-Development & Commercialization Agreement
BridgeBio Pharma, Inc., through its affiliate QED Therapeutics, Inc., and Helsinn Group recently announced a global collaboration and licensing agreement to further develop and commercialize…
Tarsus Pharmaceuticals & LianBio Announce Strategic Development & Commercialization Partnership
Tarsus Pharmaceuticals, Inc. and LianBio recently announced a strategic partnership to develop and commercialize TP-03 in Greater China (mainland China, Hong Kong, Taiwan, and Macau)…..
Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
Pfizer Inc. and BioNTech SE recently announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2….
Ajinomoto & Bright Peak Therapeutics Enter Research Collaboration & License Agreement
Ajinomoto Co., Inc. and Bright Peak Therapeutics Inc. recently announced a research collaboration and exclusive license agreement to incorporate AJICAP, Ajinomoto Co.’s proprietary….
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….
SPECIAL FEATURE - Excipients: Far From Inactive
Contributor Cindy Dubin speaks with several innovative excipient companies that assert novel excipients – agglomerated, co-processed, and multifunctional – actively and safely affect formulation stability, solubility, and bioavailability as well as foster faster drug disintegration.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals of 2020
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
FORMULATION FORUM - Understanding of Amorphous Solid Dispersions & Their Downstream Development
Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.
INHALATION DELIVERY - Inhaled Drug Development: Optimizing Delivery
Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.
BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
OPEN INNOVATION PLATFORM - Incentivizing Drug Delivery Research Using an Open Sharing Platform
Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.
EXECUTIVE INTERVIEW - Celanese: Better Therapeutic Outcomes From Better Drug Delivery
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
NUCLEAR β-CATENIN INHIBITOR - TBL1 - A Novel Target for Safe & Effective Blockade of the Nuclear β-catenin Signaling Pathway
Ruolan Han, PhD, explains how targeting TBL1/TBLR1 enables specific silencing of oncogenic Wnt target gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt pathway.
EXECUTIVE INTERVIEW - SDP Oncology: Uncovering New Biology
David J. Bearss, PhD, Chief Scientific Officer and Global Head of Research at SDP Oncology, discusses his company’s unique structure that has supported its robust research in the tumor immune microenvironment as well as its investigational assets being studied in this space.
Clinical Trial Data on the Use of Probiotics in Outpatients With COVID-19
Researchers at the Hospital General Manuel Gea González in Mexico City have reported results from a study designed to assess the impact of four specific strains of probiotics on the rate of remission from infection with SARS-CoV-2….
