Search Results for: FORMULATION DEVELOPMENT TECHNOLOGY A Novel
Articles
Biora Therapeutics Announces Positive Clinical Trial Results for BT-600 July 1, 2024
Biora Therapeutics, Inc. recently shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in...Artelo Biosciences Presents Highly Encouraging Data Toward Developing Solid Dosage Form of ART12.11 May 29, 2024
Artelo Biosciences, Inc. recently announced Dr. Andrew Yates presented new preclinical data on ART12.11 at the CT-CANN24 conference held May...TFF Pharmaceuticals & Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing May 20, 2024
TFF Pharmaceuticals, Inc recently announced that, in collaboration with Cleveland Clinic, the company is advancing multiple multivalent universal influenza vaccines...FDA Grants Orphan Drug Designation to Biompharma’s Microbiome-Modifying Biologic May 8, 2024
BIOM Pharmaceutical Corporation recently announced Bi104, its innovative drug product, has been granted orphan-drug designation by the US FDA for...Bespak & Medicines Evaluation Unit Collaborate to Accelerate Clinical Trials on Climate-Friendly Inhalers May 3, 2024
Bespak and The Medicines Evaluation Unit (MEU) recently announced a collaboration to further accelerate the pharmaceutical industry’s transition from existing...PCI Pharma Services Begins Installation of Sterile Fill-Finish & Lyophilization Line as Part of $100-M New Facility Expansion May 2, 2024
PCI Pharma Services has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator….
Biora Therapeutics Announces Completion of Multiple-Ascending Dose Cohorts for Clinical Trial of BT-600 April 30, 2024
Biora Therapeutics, Inc. recently announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a...NeuroSense Collaborates With Lonza to Identify Exosome-Based Biomarkers to Advance Neurodegenerative Disease Treatments & Diagnostics April 9, 2024
Lonza and NeuroSense Therapeutics Ltd. recently announced a collaboration to evaluate biological changes occurring in people with neurodegenerative diseases, including...SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
Biora Therapeutics Announces Successful Completion of Single-Ascending Dose Cohorts of Phase 1 Clinical Study of BT-600 February 26, 2024
Biora Therapeutics, Inc. recently announced completion of the single-ascending dose (SAD) cohorts for its Phase 1, first-in-human clinical study of...Tarsus Announces Positive Topline Results From Phase 2a Proof-of-Concept Trial Evaluating TP-05 for the Prevention of Lyme Disease February 22, 2024
TP-05 demonstrated tolerability and statistically significant tick mortality, suggesting potential for on-demand Lyme disease prophylaxis….
SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs January 29, 2024
Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.
Vivtex Enters Research Collaboration With Astellas Pharma January 23, 2024
Vivtex Corporation recently announced it has entered a research collaboration with Astellas Pharma Inc., a global pharmaceutical company. The collaboration...Biora Therapeutics Announces Initiation of Phase 1 Clinical Study for Drug-Device combination Program January 8, 2024
Biora Therapeutics, Inc. recently announced initiation of its Phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program consisting of the orally….
Biora Therapeutics Announces New Patent for its NaviCap Targeted Oral Delivery Platform December 19, 2023
Biora Therapeutics, Inc. recently announced it received an Issue Notification from the US Patent and Trademark Office for a patent...REGULATORY AFFAIRS - Rethink the Regulatory Dynamic: A Better Approach for Being Your Product’s Best Advocate December 4, 2023
Nick Smalley says as drug device combination products grow more complex, regulations increase commensurately. However, to implement and enforce appropriate regulatory standards and truly ensure product safety, regulators must understand what it is they are regulating.
Ardena's New Aseptic Fill-Finish Plant in Ghent Receives GMP License November 29, 2023
Ardena, a leading Contract Development and Manufacturing Organization (CDMO) specializing in bringing molecules to clinic, has been granted a Good Manufacturing Practice (GMP) license by the….
Aldena Therapeutics Selects PCI Pharma Services to Manufacture & Distribute Innovative Investigational Treatment for Dermatological Diseases October 19, 2023
Aldena Therapeutics has chosen PCI Pharma Services (PCI) to formulate, package, and distribute ALD-102, an siRNA-based investigational injectable treatment for….
Daré Bioscience Announces Achievement of First Commercial Milestone Under License Agreement for XACIATO October 16, 2023
Daré to receive $1.8-million payment; eligible for additional potential milestone payments of up to $180 million and tiered double-digit royalties based on net sales…..
Company Profiles
Lyophilization Technology, Inc.
Lyophilization Technology, Inc. 30 Indian Drive Ivyland, PA 18974-1431 T: (215) 396-8373 F: (215) 396-8375 E: inquiry@lyo-t.com W: www.lyotechnology.com WHO...DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
