Formulation Development
Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension
Gyre Therapeutics recently announced the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (ETA) receptor…
Adcendo ApS Announces First Patient Dosed in Phase 1/2 ADCElerate1 Trial of ADCE-D01
Adcendo recently announced the first patient has been dosed in the Phase 1/2 ADCElerate1 clinical trial evaluating ADCE-D01 in patients with metastatic and/or unresectable soft…
RenaissThera Achieves Discovery Milestone in its Oral Obesity Drug Program
RenaissThera Private Limited recently announced a major milestone in its obesity drug discovery program targeting the glucose-dependent insulinotropic polypeptide receptor (GIPR). GIPR, an incretin receptor,…
Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i
Metsera, Inc. recently announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency,…
Avidity Biosciences Announces the Accelerated Approval Regulatory Pathway in the US is Open for Del-Brax & Initiates the Global, Confirmatory Phase 3 FORWARD Study in FSHD
Avidity Biosciences, Inc. recently announced the accelerated approval regulatory pathway in the United States is open for delpacibart braxlosiran (del-brax) in the treatment of facioscapulohumeral…
OBI Pharma Enters ADC Collaboration With TegMine Therapeutics Utilizing GlycOBI & TegMiner Enabling Technologies
OBI Pharma, Inc. and TegMine Therapeutics, Inc. have entered into an ADC-related Master Services Agreement (MSA). Under the terms of the MSA, OBI grants TegMine…
PCI Pharma Services to Provide Updates on New Manufacturing Facility
PCI Pharma Services will use the BIO International Convention, June 16-19 in Boston, as a platform to introduce its new purpose-built facility for large-scale sterile fill-finish…
AstriVax Therapeutics Initiates Clinical Development of a Hepatitis B Immunotherapy Using Launch-iT Technology
AstriVax Therapeutics NV recently announced the start of clinical development with AVX70371 for chronic hepatitis B virus (HBV) infection. The phase I RUBY study (NCT06989788)…
SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
Conduit Pharmaceuticals Enters Joint Development Agreement With Manoira
Conduit Pharmaceuticals Inc. recently announced it has entered into a joint development agreement with Manoira Corporation. Under the terms of the joint development agreement, Manoira…
HCW Biologics Completes Deliverable & Solidifies License Agreement With WY Biotech
HCW Biologics Inc. and WY Biotech Co., Ltd. recently announced WY Biotech has completed its due diligence related to HCWB’s technology transfer report, including the…
Elicio Therapeutics Secures $10 Million in Financing
Elicio Therapeutics, Inc. recently announced it has entered a $10-million senior secured promissory note with existing investor, GKCC, LLC. The proceeds from the Note Financing,…
FORMULATION FORUM - Manufacturing of Solid Oral Dosage Forms by Direct Compression
Jim Huang, PhD, and Shaukat Ali, PhD, say not all excipients are well suited for DC, so challenges remain to find excipients compatible to DC due to certain physicochemical properties associated with poor flowability, lack of plasticity, flexibility, and compressibility.
Trethera Secures New License, Strengthening TRE-515 Intellectual Property Portfolio & Extending Market Exclusivity to 2045
Trethera Corporation recently announced it entered an exclusive, worldwide licensing agreement with the University of California, Los Angeles (UCLA). The license expands Trethera’s intellectual property…
OUTSOURCING - The Power of Partnerships Fueling Biopharma Progress With Advanced Tools & Expert Support
Lisa V. Sellers, PhD, says as biopharma moves faster and new drug approvals reach an all-time high, relationships with critical component suppliers and expert development and manufacturing partners cannot be an afterthought.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Fast, Flexible, and Focused: The Secrets of a Successful CDMO Partnership
Steven Facer, Senior Vice President of Sales and Marketing at Adare Pharma Solutions, shares practical insights on what makes CDMO partnerships work and what can cause them to fall short.
PROTEIN BARCODING - Streamlining mRNA Therapeutic & Vaccine Development
Meredith Carpenter, PhD, reviews how lipid nanoparticles have emerged as a powerful tool for delivery due to their low immunogenicity compared to viral vectors, along with their ability to encapsulate and protect nucleic acids and facilitate their entry into cells.
Rilzabrutinib Granted Orphan Drug Designation in the US for Sickle Cell Disease
The US FDA has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation,…
Symeres & Yoneda Labs Use AI to Optimize Cross-Coupling Reactions
Yoneda Labs, a leader in computational tools for reaction optimization, has successfully collaborated with Symeres, a leading transatlantic, small molecule contract research and manufacturing organization.…
Coya Therapeutics Announces Issuance of New Patent Protecting Methods of Producing Recombinant Human Interleukin-2 Liquid Formulations
Coya Therapeutics, Inc. recently announced the issuance of a US patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the US…
