Formulation Development
SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination With Cetuximab
SOTIO Biotech recently announced the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and….
Evaxion Receives FDA Fast-Track Designation for Personalized Cancer Immunotherapy
Evaxion Biotech A/S recently announced the US FDA has granted fast track designation for the company’s personalized cancer therapy, EVX-01, in combination….
Strata Oncology Announces Addition of Gilead as Strata PATH Trial Collaborator
Strata Oncology, Inc. recently announced Gilead Sciences, Inc. has agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH) trial by providing…
(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
BriaCell Announces Positive End of Phase 2 Meeting With the FDA for Bria-IMT Combination in Advanced Metastatic Breast Cancer
BriaCell Therapeutics Corp. is pleased to announce that it has received agreement and positive feedback from its End of Phase 2 meeting with the FDA…
Avidity Biosciences Granted FDA Fast Track Designation for the Treatment of Facioscapulohumeral Muscular Dystrophy
Avidity Biosciences, Inc. recently announced the US FDA has granted Fast Track designation to AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD…
Teon Therapeutics Announces Clinical Trial Collaboration With Merck to Evaluate Novel Oral Immune Response Modifier in Combination with KEYTRUDA
Teon Therapeutics (Teon) recently announced it has entered into the clinical trial collaboration agreement with Merck for the combination arm of Teon’s ongoing, two-armed, open-label, dose….
Ingenza Collaborates With Amplifica to Advance Novel Alopecia Treatments
Industrial biotech specialist Ingenza recently announce it is collaborating with clinical-stage biopharmaceutical company Amplifica Holdings Group, Inc. to develop an innovative treatment to address androgenic…
Needle-Free Patch Technology for mRNA Vaccines Aims to End Need for Frozen Storage & Improve Access
CEPI, the Coalition for Epidemic Preparedness Innovations, and Vaxxas have recently signed a partnership agreement to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology in a project….
Kinarus Therapeutics Reports Preclinical Data in Lung Fibrosis & Discloses Clinical Development Plan
Kinarus Therapeutics AG recently announced preclinical data supporting the potential effectiveness of its lead clinical candidate, KIN001, as an oral treatment for idiopathic pulmonary fibrosis…
TTP introduces Cellular Origins, Focused on Delivering Ccalable Manufacture of Cell & Gene Therapies
TTP plc recently announced the launch of Cellular Origins, a TTP Company. Cellular Origins is a TTP spin-out, created to enable scalable, cost-effective, and efficient…
Scaling Up Capacity, Eitan Medical Opens New Manufacturing Facility Bolstered by Semi-Automated Production Lines
Eitan Medical recently announced today the opening of its new manufacturing facility at the company’s headquarters. On-site manufacturing will support Eitan Medical’s production scale of its…
Catalent Appoints Ricardo Zayas as North American Biologics Operations Leader
[caption id="attachment_137073" align="alignleft" width="138"] Ricardo Zaya[/caption] Catalent, Inc. recently announced the appointment of Ricardo Zayas as Senior Vice President, Operations, Biologics North America. Mr. Zayas…
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
FORMULATION FORUM - Sterile & Non-Sterile Formulation Capabilities - A CDMO Perspective
Jim Huang, PhD, and Shaukat Ali, PhD, explain how their company is expanding its footprints in sterile manufacturing to handle innovative molecules and leverage its services to emerging and specialty and biopharma companies requiring cGMP materials for preclinical tox and clinical studies.
DRUG-ELUTING IMPLANTS - Sustained-Release Implants - A Targeted Approach to Drug Delivery
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 2023?
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
FUNCTIONAL EXCIPIENTS - Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs)
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
CLINICAL TRIALS - Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
DISCOVERY PLATFORM - Reverse-Engineering Targeted Immunotherapy
Bob Lechleider, MD, explains how by applying a patient-first technology and looking for clues in the immune system, a powerful tool can be harnessed – the human body – to identify and produce new molecules to make medicines for cancer patients.
