Formulation Development
SAB Biotherapeutics Announces SAB-176 Met its Primary Endpoint in Phase 2a Challenge Study in Adults Infected With Influenza Virus
SAB Biotherapeutics recently announced that SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and….
BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated With Schizophrenia & Bipolar Disorders
BioXcel Therapeutics, Inc. recently announced the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of….
Arch Biopartners’ Lead Drug LSALT Peptide to Enter the Canadian Treatments for COVID-19 (CATCO) Trial
Arch Biopartners Inc. recently announced its lead drug candidate, LSALT Peptide (LSALT and Metablok) will enter the Canadian Treatments for COVID-19 (CATCO) human trial, a…
Vaxart Announces Acquisition of Second GMP Manufacturing Facility
Vaxart, Inc. has entered into an agreement with Kindred Bioscience, Inc. for the purchase of KindredBio’s manufacturing equipment and sublease of its GMP (Good Manufacturing…
2022 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Amorphous Nanoparticles for Drug Delivery of Poorly Water-Soluble Compounds
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
APTAMER TECHNOLOGY - From Postal Codes to GPS: Building Better Drug Conjugates With Aptamers
David Bunka, PhD, and Emily Robinson, PhD, focus on a new breed of affinity binders that can be used as an alternative to antibody therapeutics and has the potential to reshape the industry, delivering new medicines with improved safety and efficacy profiles and reduced healthcare costs.
EXECUTIVE INTERVIEW - Quotient Sciences: Unique Considerations & Challenges When Developing Palatable Pediatric Formulations
Nazim Kanji, Executive Director, Pediatric Services at Quotient Sciences, discusses the unique considerations and challenges when developing palatable pediatric formulations, so that molecules can become cures, fast.
INHALATION THERAPY - An Overview to Drug-Nebulizer Combination Development With Biologics
Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.
WHITE PAPER - A Safe & Efficient Analytical Method for Identity Determination of Oligonucleotides is Now Available
By: Alexandra H. Heussner, PhD, Laboratory Manager ASL, and Melanie Zerulla-Wernitz, PhD, Head of ASL, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG [caption id="attachment_132725" align="alignleft" width="150"] Alexandra H. Heussner,…
Olema Oncology Announces First Clinical Data on OP-1250 in Advanced ER+/HER2- Breast Cancer
Olema Pharmaceuticals, Inc. recently announced the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a…
Heat Biologics Unveils a Novel Cellular Vaccine Platform Targeting Known & Unknown Emerging Biological Threats
Heat Biologics, Inc. recently unveiled its new RapidVax cellular vaccine platform at the 2021 World Antiviral Congress. RapidVax is designed as a rapid programmable vaccine…
Lonza & Bioqube Ventures Sign Framework Agreement for the Future Development & Manufacture of Biologics & Small Molecules for Bioqube’s Portfolio Companies
Bioqube Ventures, a European venture capital firm with a dual investment model including venture creation, and Lonza, a global development and manufacturing partner to the…
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH
Hepion Pharmaceuticals, Inc. recently announced the US FDA has granted Fast Track designation for the company’s lead drug candidate, CRV431, for the treatment of NASH.…
Akoya Biosciences Secures CLIA Lab Certification, a Milestone for Applying its Spatial Biology Technologies to Accelerating Precision Cancer Therapies
Akoya Biosciences, Inc., The Spatial Biology Company, recently announced its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, MA, has received its Certificate of Registration from the….
TARGETED ONCOLOGY THERAPIES - Harnessing Nature’s “Cues” to Selectively Activate the Immune System to Attack Cancer
Dan Passeri, MSc, JD, reviews a new class of synthetic biologic drugs engineered and designed to leverage the beneficial effect of IL-2 to selectively stimulate the proliferation and cytotoxic activity of disease-relevant T cells against cancer.
Gb Sciences Accelerates Drug Development Via Innovative Biopharma Technology & Strategic Partnerships
Recognizing the glacial pace of traditional drug research and development processes and the adverse effect of this on patients, biopharmaceutical company Gb Sciences has taken innovative steps to speed up….
RespireRx Pharmaceuticals Announces Publication of Preclinical Results Supporting the Use of AMPAkines in the Treatment of Human Spinal Cord Injury
RespireRx Pharmaceuticals Inc. recently announced the publication by Dr. David Fuller (University of Florida) and his colleagues of two new, scientific articles in major, peer-reviewed…
Adial Pharmaceuticals Announces Positive Preclinical Data for PNV2 as a Drug Candidate for Triple Negative Breast Cancer
Adial Pharmaceuticals, Inc. recently announced positive preclinical data for PNV2 in an animal model of triple negative breast cancer (TNBC). Based on the strength of…
Ocuphire Announces Enrollment of First Patients in Second Phase 3 Pivotal Trial (MIRA-3) for Nyxol in Reversal of Mydriasis
Ocuphire Pharma, Inc. recently announced the first subjects have been enrolled in the MIRA-3 Phase 3 pivotal trial evaluating Nyxol Eye Drops in the reversal…
