Formulation Development
Catalent Acquires Additional Facility at its Gosselies, Belgium, Campus for Commercial-Scale Plasmid DNA Manufacturing
Catalent and Promethera Biosciences recently announced that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its….
FORMULATION FORUM - A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
In this study, the authors monitor acetylsalicylic acid (ASA) hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of the ASA.
The FDA Expands Collaboration With CN Bio to Investigate Lung-on-a-Chip Model for Inhaled Drug Evaluation Applications
CN Bio recently announced the US FDA has extended its research collaboration for an additional 3 years. The scope of the research carried out with…
Scipher Applies Spectra Platform to Discover Drugs Targeting Autoimmune Patients Refractory to Existing Therapies
Scipher Medicine recently announced the launch of Scipher Therapeutics, focused on discovering new targets and drugs for patients not responding to approved therapies in the…
Recce Pharmaceuticals Announces Positive Data on Bactericidal Activity of RECCE 327 Against All Six ESKAPE Pathogens
Recce Pharmaceuticals Ltd recently announced announce RECCE 327 (R327) has demonstrated bactericidal activity against all six antibiotic resistant ESKAPE pathogens, including drug-resistant mutations (superbugs) as…
Cocrystal Pharma Provides Update on its COVID-19 Antiviral Discovery & Development Programs
Cocrystal Pharma, Inc. recently announced progress in developing broad-spectrum antiviral drug candidates that target coronaviruses including SARS-CoV-2, the coronavirus that causes COVID-19. Cocrystal initiated its…
SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
FORMULATION FORUM - Considerations in Formulation Development of Injectable Solutions
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2020
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
DRY-POWDER THERAPEUTICS - Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler
Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.
EXECUTIVE INTERVIEW - Micropore: Innovation in Drug Delivery
Dai Hayward, CEO at Micropore, discusses his company’s expertise and underpinning technology in the development of safe, efficient, and scalable continuous manufacturing of drug delivery solutions.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 3 – Mind the Axle
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
EXECUTIVE INTERVIEW - Lexaria Bioscience Corp.: Stretching Its Legs
John Docherty, President of Lexaria, discusses how the company’s recent uplist to the NASDAQ has resulted in its largest capital injection to date, which will allow it to focus on preclinical and clinical testing programs for DehydraTECH formulations across three main areas of interest.
Vetter & Rentschler Biopharma Further Strengthen Strategic Alliance
Rentschler Biopharma and Vetter, two globally operating Contract Development and Manufacturing Organizations (CDMOs), recently announced their strategic collaboration has taken key steps….
Daré Bioscience Announces the Presentation of DARE-BVFREE Phase 3 Clinical Trial Results
Daré Bioscience, Inc. recently announced that data from the DARE-BVFREE Phase 3 study of DARE-BV1, a thermosetting vaginal gel for the treatment of bacterial vaginosis, was….
InveniAI & Shionogi Enter AI-Powered Multi-Target Drug Discovery Collaboration
InveniAI LLC recently announced a multi-target drug discovery collaboration with Shionogi & Co., Ltd.; the multi-year collaboration will combine InveniAI’s AI platform….
AavantiBio & Catalent Announce Partnership to Support Development & Manufacturing of Gene Therapies
AavantiBio and Catalent recently announced a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA)….
Voyager Therapeutics Receives FDA Clearance of IND Application for Gene Therapy Candidate
Voyager Therapeutics, Inc. recently announced the US FDA has removed its clinical hold on the company’s Investigational New Drug (IND) application for VY-HTT01, a gene…
ENZYVANT Resubmits BLA to FDA for RVT-802 for Pediatric Congenital Athymia
Enzyvant recently announced the resubmission of the Biologics Licensing Application (BLA) to the US FDA for RVT-802, cultured human thymus tissue. RVT-802 is a one-time…
ImCheck Announces Initiation of US Enrollment in Phase 1/2a EVICTION Trial for ICT01
ImCheck Therapeutics recently announced the first patient in the US has been dosed at the Yale University Cancer Center in New Haven, CT, as part…
