Formulation Development
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…
Clinical Data Shows Noxopharm’s Veyonda May Prevent Cytokine Storm
Australian clinical-stage drug development company Noxopharm Limited recently announced that in a cohort of 18 patients with moderately severe cases of COVID-19, interim data in its…
Brickell Biotech Completes Patient Enrollment in US Phase 3 Pivotal Cardigan I Study
Brickell Biotech, Inc. recently announced completion of patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed…
MacroGenics Adopts Genedata Profiler to Enhance Development of Immunotherapies
Genedata recently announced a long-term partnership agreement with MacroGenics, a biopharmaceutical company and an emerging leader in developing and commercializing innovative immune-oncology therapeutics…..
Agenus Submits Balstilimab Biologics License Application to the US FDA for Patients With Recurrent or Metastatic Cervical Cancer
Agenus Inc. recently announced the submission of a Biologics License Application (BLA) to the US FDA for the accelerated approval of….
ERS Genomics & NUVISAN ICB Sign CRISPR/Cas9 License Agreement
ERS Genomics Limited and NUVISAN Innovation Campus Berlin (ICB) GmbH recently announced a non-exclusive license agreement granting NUVISAN ICB access to….
CureVac Swiss AG Initiates Rolling Submission Process for mRNA-Based COVID-19 Vaccine Candidate
The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. recently announced initiation of a rolling submission for CVnCoV, the company’s mRNA-based COVID-19 vaccine….
XOMA’s Royalty Portfolio Grows With Addition of Three Royalty Assets
XOMA Corporation recently announced its portfolio of potential future milestone and royalty assets has increased with the addition of three Affimed N.V. innate cell engager…
