Formulation Development
ADMA Biologics Highlights Expanded Intellectual Property Portfolio
ADMA Biologics recently announced that it has received another Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent application related to its…..
Evelo Biosciences Announces Biomarker Data Showing Drug is Orally Delivered Dual Cytokine Inhibitor for Inflammatory Diseases
Evelo Biosciences, Inc. recently announced biomarker data for EDP1815, its lead inflammation product candidate. Interim data from individuals in the ongoing Phase 1b clinical trial…
SPECIAL FEATURE - Improving Bioavailability & Solubility: Understand Your Molecule
Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.
INTRATUMORAL DELIVERY - Combining Local & Systemic Treatments: Could Immuno-Oncology Finally Enable Local Intratumoral Delivery?
Lewis H. Bender, MA, MBA, says cancer is a local and systemic disease, and new forms of local treatment, such as intratumoral dosing coupled with systemic immunotherapy, are being explored.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 2
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
EXECUTIVE INTERVIEW - Noxopharm: Introducing a Novel & Potentially Transformative Drug Candidate in the Treatment of Cancer
Graham Kelly, Founder, Executive Chairman, and CEO of Noxopharm, discusses the company’s innovative approach to cancer treatment.
BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications
Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2019 product approvals.
HIGH PURITY EXCIPIENTS - A Simple Solution to a Complex Problem
William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.
FORMULATION FORUM - Rational Design & Development of Long-Acting Injectable Dosage Forms
Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been….
Pii Expands Aseptic Filling Capabilities With Fully Robotic Filling Line
Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), recently announced the expansion of its aseptic filling capacity and….
Oramed Reports Positive Results in the Final Cohort of its Phase 2b Oral Insulin Trial
Oramed Pharmaceuticals Inc. recently announced positive topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of its lead…
Novavax Advances Development of Novel COVID-19 Vaccine
Novavax, Inc. recently announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19….
Arecor Achieves Second License Milestone Payment From Global Pharmaceutical Partner
Arecor Ltd recently announced it has achieved an important second, contractual milestone with one of its pharmaceutical partners….
Alimera Sciences Meets Revenue Milestone & Accesses Additional $2.5 Million
Alimera Sciences, Inc. recently announced it has drawn down the remaining $2.5 million under the $45-million term loan agreement with its current lenders, investment affiliates managed by…..
TrakCel & Ori Biotech Sign Collaboration Agreement
TrakCel and Ori Biotech Ltd recently announced a non-exclusive strategic partnership to achieve supply chain orchestration within closed system manufacturing for the cell and gene therapy sector.…
Theralase Advances Its Pivotal Phase 2 Non-Muscle Invasive Bladder Cancer Study
Theralase Technologies Inc. recently announced that Nova Scotia Health Authority (NSHA) Research Ethics Board (REB) has approved the commencement of a Pivotal Phase 2 Non-Muscle…
Spring Bank Announces New Clinical Collaboration With Roche
Spring Bank Pharmaceuticals, Inc. recently announced a new clinical collaboration with Roche to explore the co-administration of SB 11285, Spring Bank's intravenously (IV)-administered STING (STimulator…
Perrigo & Catalent Announce FDA Approval
Perrigo Company plc and its partner Catalent Pharma Solutions recently announced the US FDA has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate…
FDA Grants IND Approval to Promising Anti-Cancer Agent
Noxopharm recently announced the US FDA has approved the Investigational New Drug (IND) application for Veyonda for combination treatment with doxorubicin in patients with soft…
