Formulation Development
AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis
AzurRx BioPharma, Inc. recently announced it has entered into an agreement with PPD, Inc. for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized….
SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies
SOTIO recently announced new preclinical data of its antibody-drug conjugate (ADC), SOT102 (formerly SO-N102), for the treatment of solid tumors in a virtual….
Artelo Biosciences Doses First Patient in CAReS Study for the Treatment of Cancer-Related Anorexia & Weight Loss
Artelo Biosciences, Inc. recently announced the first patient has been dosed in the company’s Phase 1/2 Cancer Appetite Recovery Study (CAReS) of ART27.13….
Calixar Invests in Pipeline of Highly Druggable Membrane Protein Targets & Native Antigens
Calixar recently announced its €1M ($1.2M) investment in a new pipeline of complex therapeutic targets and native antigens of high relevance for pharmaceutical companies. This…
Longeveron Announces Positive Results of Phase 1 Clinical Study of Lomecel-B Cell Therapy
Longeveron Inc. recently announced the final results of its Phase 1 clinical study evaluating the safety and efficacy of intravenous (IV) administration of Lomecel-B, an…
Akston Biosciences Launches Phase 1/2 Clinical Trial of Second-Generation COVID-19 Vaccine
Akston Biosciences Corporation recently announced the first participants have been dosed in an open-label trial of AKS-452, its COVID-19 vaccine candidate. The trial is managed…
Catalent Biologics Completes Madison Facility Expansion to Double Clinical & Commercial Drug Substance Capacity
Catalent recently announced it has completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, WI, and…
Akouos Receives Orphan Drug & Rare Pediatric Disease Designations
Akouos, Inc. recently announced the US FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy…
Where Do We Stand on Poorly Soluble Drugs and Peptides in Oral Delivery?
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
AEON Biopharma Doses First Patient in Phase 2 Trial of ABP-450 for the Treatment of Cervical Dystonia
AEON Biopharma, Inc. recently announced the initiation of patient dosing in a Phase 2 study of ABP-450 for the treatment of cervical dystonia. The company…
Yumanity Therapeutics Announces Study Demonstrating In Vivo Efficacy of YTX-7739 in a Glioblastoma Multiforme (GBM) Mouse Model
Yumanity Therapeutics recently announced results of a study that demonstrate in vivo efficacy, including increased median overall survival, of YTX-7739 in a mouse model for…
AzurRx BioPharma Initiates Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections
AzurRx BioPharma, Inc. recently announced it has initiated its Phase 2 RESERVOIR clinical trial of a proprietary oral formulation of micronized niclosamide (FW-1022) for the…
uniQure Announces Completion of Enrollment in First Cohort of Phase 1/2 Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
uniQure recently announced the completion of patient enrollment in the first dose cohort of a randomized, double-blinded, Phase 1/2 clinical trial of AMT-130 for the…
AIM ImmunoTech Posts New Developments in Intranasal COVID-19 Treatment Clinical Study
AIM ImmunoTech Inc. recently announced it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM’s drug Ampligen…
New England Journal of Medicine Publishes Results of the PULSAR Phase 2 Trial of Sotatercept in Patients With Pulmonary Arterial Hypertension
Acceleron Pharma Inc. recently announced the New England Journal of Medicine has published results of the PULSAR Phase 2 trial of sotatercept in patients with pulmonary…
I-Mab & ABL Bio Announce First Patient Dosed in Phase 1 Trial of Bispecific Antibody TJ-L14B/ABL503 in Patients With Advanced or Metastatic Solid Tumors
I-Mab and ABL Bio, Inc. recently announced the first patient has been dosed in a Phase 1 trial for bispecific antibody TJ-L14B/ABL503. The Phase 1 clinical trial is an open-label….
Cidara Therapeutics Announces Agreement With Janssen to Develop & Commercialize AVCs for the Prevention & Treatment of Influenza
Cidara Therapeutics, Inc. recently announced it has entered into an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize….
Progenity & Ionis Pharmaceuticals Enter Agreement to Evaluate Progenity’s Ingestible Oral Biotherapeutics Technology for Delivery of Antisense Therapies
Progenity, Inc. recently announced an agreement with Ionis Pharmaceuticals to evaluate the safety, tolerability, and performance of Progenity’s Oral Biotherapeutics Delivery System (OBDS) for oral systemic delivery of….
Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio
Moderna, Inc. and Catalent, Inc. recently announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other….
