Formulation Development
Fate Therapeutics Announces FDA Clearance of IND Application
Fate Therapeutics, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for FT596, the company’s first off-the-shelf chimeric antigen…
Krystal Biotech Announces Initiation of Phase 1/2 Study
Krystal Biotech Inc. recently announced the initiation of the Phase 1/2 study of KB105 in transglutaminase-1 (TGM1) deficient autosomal recessive congenital ichthyosis (ARCI). The study, termed…
Atossa Genetics Announces Completion of Enrollment & Dosing in Phase 1 Clinical Trial
Atossa Genetics Inc. recently announced that all participant activities have been completed in its Phase 1 clinical trial of a new proprietary modified-release oral tablet form…
Innovent & Lilly Set to Transform Diabetes Medication as Clinical Trials Begin
Innovent Biologics, Inc. recently signed a licensing agreement with Eli Lilly and Company (Lilly), one of America’s leading pharmaceutical companies, for the development and potential…
Apellis Dosed First Patient in Phase 3 Study
Apellis Pharmaceuticals Inc.recently announced the dosing of the first patient in the Phase 3 clinical study PRINCE (APL2-308), evaluating the efficacy and safety of APL-2…
Passage Bio Closes $110-Million Series B Financing
Passage Bio recently announced the closing of a $110-million Series B financing. The financing round was led by Access Biotechnology with participation from existing investors,…
Nkarta Therapeutics Raises $114 Million in Series B Financing to Advance Multiple Programs Into Clinical Trials
This financing is intended to support two clinical trial programs of NKX101, Nkarta’s allogenic NK cell therapy targeting NKG2D, in patients with either…..
Foamix Announces New US Patent That Expires in 2037
Foamix Pharmaceuticals Ltd. recently announced the US Patent and Trademark Office has issued US Patent No. 10,398,641 covering a method of treating…….
Kintai Therapeutics Announces Collaborations With Leading Academic Centers
Kintai Therapeutics recently announced it has established new collaborations with leading academic institutions to identify novel molecules that play a fundamental role in microbe to…
PCI Strengthens Position in Europe With Investment in Ireland
PCI Pharma Services (PCI), a leading biopharmaceutical outsourcing services provider, has solidified its leadership position in the EU with strategic investment to deepen its presence…
Adaptimmune & Noile-Immune Announce Agreement to Develop SPEAR T-Cell Products
Adaptimmune Therapeutics plc and Noile-Immune Biotech, Inc. recently announced they will co-develop next-generation SPEAR T-cell products, incorporating Noile-Immune’s PRIME (proliferation inducing and migration enhancing) technology,…
Hovione Signs Collaboration Agreement With Kiel University on High-Dose Dry Powder Inhalation Delivery
Hovione Technology recently announced it has entered into a collaboration agreement with Kiel University, Institute of Pharmacy in Germany, a reference research institution on inhaled drug delivery.
BIOLOGICS DELIVERY - Enabling Biologic Drug Delivery of Volumes Beyond 1 mL
Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
INTRATUMORAL DELIVERY - Arming the Immune System; Turning Cold Tumors Hot
Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.
ON-TARGET DELIVERY - Lipid-Based System Introduces a Novel Approach for an HIV Vaccination
Fabrice Navarro, PhD, summarizes recent disappointing clinical trial results for HIV vaccines and reports on CEA-Leti’s new approach based on engineered lipid nanoparticles that deliver p24 (a viral protein that optimizes the CpG adjuvant’s effect) with pinpoint accuracy.
Ajinomoto Bio-Pharma Services Acquires Remaining Interest in Granules OmniChem Joint Venture in India
Ajinomoto Bio-Pharma Services recently announced its intention to purchase the remaining 50% ownership interest in its Visakhapatnam, India, joint venture, Granules OmniChem Private Limited (GOC) from its….
THERANOSTICS - The Outlook for the Theranostic Radionuclide Approach to Neuroendocrine Tumors & Other Cancers
Eric P. Krenning, MD, PhD, and Rachel Levine provide a review of the evolution and development of theranostics, in general, citing the theranostic radionuclide approach to the management of neuroendocrine tumors to highlight this evolving modality.
