Formulation Development
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….
Assembly Biosciences & Door Pharmaceuticals Sign Collaboration & Option Agreement
Assembly Biosciences, Inc. and Door Pharmaceuticals, LLC recently announced the companies have signed an exclusive, 2-year collaboration and option agreement focused on the development of….
XOMA Earns $2-Million Milestone From Takeda
XOMA Corporation recently announced it has earned a $2-million milestone payment from Takeda Pharmaceutical Company Limited as the first patient has been dosed….
Albireo Pharma Announces New Phase 3 Data That Shows Durable Response to Odevixibat in a Rare Pediatric Liver Disease
Albireo Pharma, Inc. recently announced new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions in serum bile acids (sBAs) and improvements in…
Beam Therapeutics Presents First Data Highlighting Base Editing Program for Glycogen Storage Disease Type Ia
Beam Therapeutics Inc. recently announced the company will present preclinical data from its liver-focused programs, including the first data highlighting its novel base-editing strategy for…
Cambrex to Invest $50 Million to Expand Multipurpose Large-Scale Manufacturing Capabilities in the US
Cambrex recently announced it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet…
CalciMedica Announces Publication of Preclinical Data Demonstrating the Pathological Role of Microglial CRAC Channels in Ischemic Stroke
CalciMedica Inc. recently announced the publication of preclinical data demonstrating a pathological role for CRAC channel-mediated microglial calcium activity in ischemic brain injury in the…
