Formulation Development
Immunocore Announces Clinical Trial Collaboration With Sanofi
Immunocore Holdings Plc recently announced it has entered into a clinical trial collaboration and supply agreement with Sanofi…..
Zai Lab & Novocure Announce Phase 2 Pilot Study Evaluating Tumor Treating Fields Together With Standard-of-Care Chemotherapy Meets Primary Endpoint for First-Line Treatment of Gastric Cancer
Zai Lab and Novocure recently announced the EF-31 Phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields (TTFields) together with standard-of-care…
Evonik Invests $220 Million to Build New Lipid Production Facility for mRNA-based Therapies in the US
Evonik is building a new, highly flexible, global-scale production facility for pharmaceutical lipids in the US. The new plant at Evonik’s Tippecanoe site in Lafayette,…
4P-Pharma & Delta 4 Join Forces to Find & Develop Treatments for a Rare Autoimmune Chronic Liver Disease
4P-Pharma and Delta 4 recently announced the signing of a collaboration agreement in which both companies will jointly identify and develop first-in-class drug candidates for a rare autoimmune chronic liver….
Teon Therapeutics Announces FDA Acceptance of IND Application for Novel, Oral Immune Checkpoint Inhibitor
Teon Therapeutics recently announced the acceptance by the US FDA of Teon’s Investigational New Drug (IND) application for the study of TT-816. TT-816 is a novel, oral cannabinoid CB2 receptor….
PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate
PDS Biotechnology Corporation recently announced the US FDA has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). PDS0101 in combination…
Biogen & Samsung Bioepis’ & Biogen's BYOOVIZ (ranibizumab-nuna) Launches in the US
Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab), has been launched….
Vaxart Reports Positive Preliminary Data from Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults
Results of the trial show a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells (ASCs), consistent with previous…
WHITEPAPER - Protecting Workers and the Environment: Facilities and Processes Key to Safely Making Highly Potent Drug Products
Handling HPAPI drug products requires skill, expertise and knowledge of safety considerations. This whitepaper examines the importance of US based drug product manufacturing and facility requirements to safely and efficiently manufacture solid oral dosage (SOD) HPAPI products….
PLATFORM TECHNOLOGY - Confident Silence: Delivering on the Promise of siRNA Therapies
Giles Campion, MD, says while the liver offers plenty of fertile ground for developing siRNAs therapies to treat many diseases, many disease-related genes are not highly expressed in the liver. For this reason, the next great challenge in the field is delivering siRNA to tissues outside the liver.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 3, Drug Delivery and Formulation Pipeline Trends
In part 3 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, provides additional insights into the nature of the current pipeline in terms of development phase, delivery route, molecule type, and disease area taken from PharmaCircle’s Pipeline Dynamics module.
EXECUTIVE INTERVIEW - BIOVECTRA: mRNA & the Future of Pharma
Marc Sauer, PhD, discusses his new position, growth at BIOVECTRA, and how he believes mRNA technologies can best be leveraged to improve the lives of patients.
CordenPharma Increases xRNA-based Capabilities with a Strategic Investment in LNP Formulation Services at its Caponago Injectable Facility
CordenPharma has recently increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy. The company reports that it is investing over €10M in new Lipid Nanoparticle (LNP) formulation,….
BIORESORBABLE POLYMERIC MATRICES - Convergence of Materials Science & Drug Development to Treat Challenging ENT Diseases
Maria Palasis, PhD, and Robert Kern, MD, review how The XTreo platform represents a unique and powerful convergence of materials science, drug development, and formulation chemistry, enabling the local delivery of medication to anatomical spaces not accessible by conventional therapeutic approaches.
EXECUTIVE INTERVIEW - Catalent: Developing & Delivering Billions of Doses of Drugs Every Year
Alessandro Maselli, President and Chief Operating Officer of Catalent, talks about his company’s unique approach to drug development partnerships as he prepares to become the company’s new President and Chief Executive Officer on July 1, 2022.
SYNTHETIC ANTI-INFECTIVES - Synthetic Polymers Offer a New Class of Anti-Infectives
James Graham believes synthetic anti-infectives offer a potential solution to the obstacles encountered by naturally derived antibiotics in the constant arms race against antimicrobial resistance.
Lonza Completes Dedicated Early Clinical Phase Development & Manufacturing Facility in Bend (OR)
Lonza has enhanced its offering for customers in the early phases of their clinical trials by adding a dedicated Early Phase Clinical Manufacturing facility at…
Eagle Pharmaceuticals Announces Submission of NDA to FDA for a Beta-1 Adrenergic Blocker
Eagle Pharmaceuticals, Inc. recently announced that AOP Orphan Pharmaceuticals GmbH, a member of the AOP Health Group, with whom Eagle entered into a licensing agreement…
Denali Therapeutics & Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
Denali Therapeutics Inc. and Biogen Inc. recently announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety…
