Formulation Development
Context Therapeutics Announces Encouraging Preclinical Data From Two Programs
Context Therapeutics Inc. recently announced encouraging preclinical data from two pipeline programs, including in vivo combination and immunomodulation data evaluating onapristone extended release (ONA-XR), the company’s…
Enteris BioPharma Highlighted as Game Changer in Special Feature on Innovative Technologies for Improving Drug Solubility & Bioavailability
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq:…
VYNE Therapeutics Announces Positive Phase 1b Efficacy Data From Phase 1b/2a Trial
VYNE Therapeutics Inc. recently announced positive efficacy results from the Phase 1b segment of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of…
FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
Catalent Acquires Facility in Oxfordshire to Expand Biologics Capabilities in the UK & Across Europe
Catalent recently announced the acquisition from Vaccine Manufacturing and Innovation Centre UK Limited (VMIC Ltd.) of a biologics development and manufacturing facility currently under….
Rhythm Pharmaceuticals Optimizes Design of EMANATE & DAYBREAK Clinical Trials to Advance Setmelanotide for Rare Genetic Diseases of Obesity
Rhythm Pharmaceuticals, Inc. recently announced modifications intended to optimize its Phase 3 EMANATE and ongoing Phase 2 DAYBREAK trials to focus on rare patient populations,…
Arcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp & Body Psoriasis
Arcutis Biotherapeutics, Inc. recently announced the enrollment of the last subject in its ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and…
Medidata & Celsion Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial
Celsion Corporation and Medidata recently announced they presented their findings on the use of a Synthetic Control Arm (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of….
CELL & GENE THERAPY - State of the Industry – Where is C> Headed?
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
Nurix Therapeutics Doses First Patient in Phase 1 Clinical Trial of Drug-Enhanced Cell Therapy for the Treatment of Patients With Solid Tumors
Nurix Therapeutics, Inc. recently announced the first patient has been dosed in its Phase 1 clinical trial of DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte therapy and….
Sterling Pharma Solutions Expands Capabilities & Laboratory Capacity
Sterling Pharma Solution recently announced a £1 million expansion project at its Deeside, UK site, which is the company’s dedicated bioconjugation and antibody-drug conjugates (ADCs)…
Verrica Pharmaceuticals Announces First Patient Dosed in Phase 2 Study for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy
Verrica Pharmaceuticals Inc. recently announced the first patient has been dosed in the company’s Phase 2 trial of LTX-315, a potential first-in-class oncolytic peptide, for the….
Processa Pharmaceuticals Announces First Patient Enrolled in Phase 2A Trial for the Treatment of Gastroparesis
Processa Pharmaceuticals, Inc. recently announced it has enrolled its first patient in the Phase 2A clinical trial of PCS12852 in patients with moderate-to-severe gastroparesis. Gastroparesis…
Agenus’ CD137 Agonist Advances in the Clinic, Triggering Milestone Payment From Gilead
Agenus Inc. recently announced receipt of a $5-million clinical milestone payment for AGEN2373 (conditionally active CD137 agonist). AGEN2373 is being evaluated in a Phase 1b…
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
GLOBAL REPORT - 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals
In part 1 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2021 product approvals.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
EXECUTIVE INTERVIEW - Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY - Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
BATCH RELEASE - The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
