Formulation Development
Galecto Publishes GB0139 Phase 2a Idiopathic Pulmonary Fibrosis (IPF) Results
Galecto, Inc. recently announced the publication of a paper detailing full results from a Phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in…
Biogen & Sage Therapeutics Announce Global Development & Commercialization Collaboration
Biogen Inc. and Sage Therapeutics, Inc. recently announced they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for…
Samsung Biologics Breaks Ground on Super Plant, the World’s Largest & Most Innovative Bio-Manufacturing Facility
Samsung Biologics officially began construction of its Plant 4 in Incheon, South Korea. Dubbed the "Super Plant,” the new, multi-story 238,000-square-meter construction will be the…
Baxter Biopharma Solutions Announces $50-Million Investment
Baxter International Inc. recently announced a $50-million expansion of its sterile fill/finish manufacturing facilities located in Bloomington, IN. These facilities are operated by Baxter’s BioPharma…
Gene Therapy Market to Surpass $6.21 Billion Globally, by 2027 at 13.4% CAGR
Allied Market Research published a report, titled Gene Therapy Market by Vector Type (Viral Vector and Non-viral Vector), Gene Type (Antigen, Cytokine, Tumor Suppressor, Suicide,…
BioNTech & InstaDeep Announce Strategic Collaboration & Form AI Innovation Lab to Develop Novel Immunotherapies
BioNTech SE and InstaDeep Ltd recently announced a multi-year strategic collaboration aimed at applying the latest advances in artificial intelligence (AI) and machine learning (ML) technology to develop….
Foster Corporation Enters Marketing Partnership With Aran Biomedical
Foster Corporation recently announce a new business relationship with Aran Biomedical, a global leader in biomaterial product solutions for implantable medical devices…..
Recipharm Announces Signature of Letter of Intent for Aseptic Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Recipharm, a leading contract development and manufacturing organization (CDMO), recently announced that it has signed a letter of intent with Moderna, a US-based biotech company, to formulate, fill, and….
Aravive Announces Phase 3 Trial Design for AVB-500 in Platinum Resistant Ovarian Cancer
Aravive, Inc. recently announced the company has received guidance from the US FDA on a Phase 3 trial design for AVB-500 in platinum-resistant ovarian cancer…
uniQure Announces Positive Top-Line Data From the HOPE-B Pivotal Trial of Gene Therapy
uniQure N.V. recently announced positive top-line data from its pivotal, Phase 3 HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based…
PMV Pharma Doses First Patient in Phase 1/2 Study of First-in-Class Precision Oncology Therapy
PMV Pharmaceuticals, Inc. recently announced dosing of the first patient in its Phase 1/2 clinical trial evaluating PC14586, the company’s investigational lead compound that targets…
Ocuphire Pharma Announces First Patient Enrolled in Phase 3 Clinical Trial
Ocuphire Pharma, Inc. recently announced the enrollment of the first patient in its MIRA-2 (NCT04620213) Phase 3 registration clinical trial evaluating the safety and efficacy…
Catalent Signs Commercial Supply Agreement With Blueprint Medicines
Catalent recently announced it has entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO (pralsetinib). Developed by Blueprint Medicines, GAVRETO…
AB201 Development as a Potential Treatment for COVID-19 Receives US FDA Fast-Track Designation
ARCA biopharma, Inc. recently announced the US FDA has designated as a Fast-Track development program the investigation of AB201 as a potential treatment for COVID-19.…
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Age-Appropriate Pediatric Formulation Development
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
PLATFORM TECHNOLOGY - Overcoming the Challenges of Drug Brain Delivery With a Novel Brain Delivery Vector
Mei Mei Tian, PhD, explains how the xB3 platform has the potential to support development of treatments for CNS diseases that can treat thousands of patients in the years ahead.
POLYMERIC DELIVERY SYSTEM - Next-Generation Long-Acting Implantables Using Surface-Eroding Elastomers
Stephanie Reed, PhD, Carissa Smoot, and Dennis Shull describe how PGSU ultimately offers many advantages over other polymers for long-acting implantables, particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry.
VACCINE DEVELOPMENT - COVID-19 Vaccine Focusing on T Cells to Protect the Most Vulnerable
Jeffrey Wolf, MBA, JD, says while most vaccines in development are targeted to protect healthy people, few are focusing on those who are most at risk – seniors and those with co-morbidities like heart failure, obesity, or type 2 diabetes.
Samsung Biologics Announces Strategic Manufacturing Partnership With Lilly to Accelerate Delivery of COVID-19 Antibody Treatments
Samsung Biologics’ partnership with Eli Lilly and Company is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement….
