Formulation Development
EXECUTIVE INTERVIEW - Lonza Small Molecules: Facing Up to the Challenges of Drug Development
Jan Vertommen, Lonza’s Head of Commercial Development (Small Molecules) discusses some of the challenges facing the sector and how his company is looking to address them.
CLOUD COMPUTING - Revolutionizing Antibody Discovery: The Role of Cloud Computing
Suhani Nagpal, PhD, Laura Spector, PhD, and Frank Erasmus, PhD, discuss the role of cloud computing in antibody discovery, its benefits, and its potential applications in the field of biotechnology.
REGULATORY AFFAIRS - Rethink the Regulatory Dynamic: A Better Approach for Being Your Product’s Best Advocate
Nick Smalley says as drug device combination products grow more complex, regulations increase commensurately. However, to implement and enforce appropriate regulatory standards and truly ensure product safety, regulators must understand what it is they are regulating.
EXECUTIVE INTERVIEW - Precision NanoSystems Inc. (part of Cytiva) & SCIEX: Lipid Impurities Within mRNA-LNPs
Kerstin Pohl, Senior Manager of Cell & Gene Therapy & Nucleic Acids at SCIEX, and Scott Ripley, General Manager of Nucleic Acid Therapeutics at Cytiva, dive into the detection of a new class of impurities within mRNA drugs and the impact it has on manufacturing.
LIPOSOMAL PEPTIDE THERAPEUTICS - Revolutionizing Oncology: Unleashing Innovative Strategies to Tackle Challenging, High-Value Drug Targets
Natalia Zisman, Krishna Allamneni, PhD, and Stacy W. Blain, PhD, explain how targeting downstream signaling proteins offers a promising approach to effectively mitigate the emergence of drug resistance that precision oncology therapies leave behind.
CARBOMER CHEMISTRY - Breaking Ground in Controlled Release
Nicholas DiFranco, MEM, believes by working alone or alongside other well-established excipients for controlled release such as HPMC, the power of carbomer chemistry can help drug developers to overcome common challenges associated with controlled-release formulations without resorting to more complex techniques.
Oxford Biomedica Signs Agreement to Acquire ABL Europe, Consolidating Position as a Global Pure-Play CDMO
Oxford Biomedica plc recently announced it has entered into a sale and purchase agreement with TSGH SAS, a subsidiary of Institut Mérieux SA, for the acquisition of….
GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia
GT Biopharma, Inc. recently announced the submission of an Investigational New Drug (IND) application with the US FDA for the development of GTB-3650, a 2nd…
Absci Announces Collaboration With AstraZeneca to Advance AI-Driven Oncology Candidate
Absci Corporation recently announced a collaboration with AstraZeneca to deliver an AI-designed antibody against an oncology target. This collaboration combines Absci's Integrated Drug Creation platform…
AbbVie to Acquire ImmunoGen, Including its Flagship Cancer Therapy, Expanding Solid Tumor Portfolio
AbbVie Inc. and ImmunoGen, Inc. recently announced a definitive agreement under which AbbVie will acquire ImmunoGen and its flagship cancer therapy ELAHERE (mirvetuximab soravtansine-gynx), a first-in-class….
Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara
Samsung Bioepis Co., Ltd. has recently signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between the two…
Orchard Therapeutics Receives US FDA Fast Track Designation for OTL-203 in MPS-IH
Orchard Therapeutics recently announced the US FDA has granted Fast Track designation to OTL-203, an investigational hematopoietic stem cell gene (HSC) therapy being developed for…
Tiziana Life Sciences Announces Foralumab Dosing of Four New Patients in the Expanded Access Program for Multiple Sclerosis
Tiziana Life Sciences Ltd. recently announced it has successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham…
Hovione Expands Nasal Drug Delivery Capabilities With Development of Nasal Powder Delivery Device Technology in Collaboration With IDC
Hovione and Industrial Design Consultancy (IDC) have entered into a joint development of an innovative nasal powder delivery device technology supporting local, systemic, and nose-to-brain drug delivery….
Ardena's New Aseptic Fill-Finish Plant in Ghent Receives GMP License
Ardena, a leading Contract Development and Manufacturing Organization (CDMO) specializing in bringing molecules to clinic, has been granted a Good Manufacturing Practice (GMP) license by the….
BiomX Announces Positive Topline Results From Part 2 of the Phase 1b/2a Trial Evaluating Treatment for Chronic Pulmonary Infections in Patients With Cystic Fibrosis
BiomX Inc. recently announced positive safety and efficacy results from Part 2 of the Phase 1b/2a trial evaluating the company’s novel phage cocktail, BX004, for…
Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Received Fast Track Designation for BI 764532 for the Potential Treatment of Advanced or Metastatic Large-Cell Neuroendocrine Carcinoma of the Lung
Oxford BioTherapeutics recently announced the US FDA has granted Fast Track designation to BI 764532 for the potential treatment of advanced or metastatic large-cell neuroendocrine carcinoma of….
Dyadic Announces Top-Line Results From its Successful Phase 1 Clinical Trial for a First-in-Human Filamentous Fungal-Based Vaccine Candidate
Dyadic International, Inc. recently announced successful top-line results for the Phase 1 clinical trial of its recombinant protein RBD vaccine candidate, DYAI-100. This marks the…
Lumen Bioscience Announces $5.5-Million Funding to Support New Research Program for Mucosal Vaccine Platform Technology
Lumen Bioscience recently announced $5.5 million in new funding from the US Department of Defense, operating through the Medical CBRN Defense Consortium (MCDC), to develop…
Roivant Announces Positive IMVT-1402 Initial 600-mg MAD Results That Confirm Best-in-Class Potential
Immunovant, Inc. recently announced initial data from 600-mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults. The results show that…
